{ "description": "Every record of the Maternal & Newborn Atlas in release 15708f235d73cd42, public channel.", "provenance": { "release_id": "15708f235d73cd42", "atlas": { "id": "maternal", "name": "Maternal & Newborn Atlas" }, "channel": "public", "schema_version": "0.5", "built_at": "2026-10-13T19:41:58Z", "content_digest": "15708f235d73cd4261d1862715516d5e3d111ee30c5a42a27945c5eda8858048", "runtime": { "node": "v26.0.0", "sqlite": "3.53.4" }, "engine": { "repository": "github.com/bengreen927/medical-atlas-core#engine", "commit_sha": "9b6ed54443317de51bece77ee7d6c9ee91b36402", "commit_date": "2026-10-13T19:41:28Z", "content_digest": "167936e4c6fd5d336782ceba059c194270939f2cce087bb7f5f1f49ce16aff36" }, "inputs": [ { "repository": "github.com/bengreen927/maternal-newborn-atlas/atlas/maternal.json", "commit_sha": "b7796f7c072ad715b3ee16711309e682578b676f", "commit_date": "2026-10-13T19:41:58Z", "content_digest": "71b4d6117444246e2d9a44de2b37c75220e1115a1322118ef4e9f2dcdd0eacd3" }, { "repository": "github.com/bengreen927/maternal-newborn-atlas/corpus", "commit_sha": "b7796f7c072ad715b3ee16711309e682578b676f", "commit_date": "2026-10-13T19:41:58Z", "content_digest": "8a28eae799a46a95349d9cfff100130a47eaaa32013ebd3ffef534a1861db6b1" }, { "repository": "github.com/bengreen927/maternal-newborn-atlas/research#quotes", "commit_sha": "b7796f7c072ad715b3ee16711309e682578b676f", "commit_date": "2026-10-13T19:41:58Z", "content_digest": "4d02cb16db9cdd73df039e33ea58077504d033b9d34b074b6deeff9898ab608c" }, { "repository": "github.com/bengreen927/medical-atlas-core/corpus/common", "commit_sha": "9b6ed54443317de51bece77ee7d6c9ee91b36402", "commit_date": "2026-10-13T19:41:28Z", "content_digest": "47e0ca41b1741f40dc239795b1a78ce900283aecdd94ef11cd75994b7dc0a29e" }, { "repository": "github.com/bengreen927/medical-atlas-core/research#quotes", "commit_sha": "9b6ed54443317de51bece77ee7d6c9ee91b36402", "commit_date": "2026-10-13T19:41:28Z", "content_digest": "736c2295d8a845d354e4f7ed0d0b81da570dfa6ec9bc8c1efedfb5f210f8d93d" } ], "release_metadata": "api/v1/meta.json", "about_page": "about/", "citations": { "note": "Each claim lists its citations, each naming a source snapshot: the retrieval date and content hash of what was read. Each source gives its reuse_basis.", "json": [ "downloads/15708f235d73cd42/atlas.json#/records/claims", "downloads/15708f235d73cd42/atlas.json#/records/sources" ], "csv": [ "downloads/15708f235d73cd42/csv/citation.csv", "downloads/15708f235d73cd42/csv/source.csv", "downloads/15708f235d73cd42/csv/source_snapshot.csv" ], "sqlite_tables": [ "citation", "source", "source_snapshot" ] }, "paths": "Paths are relative to the release root, the directory that holds index.html and api/." }, "reuse_terms": { "status": "chosen", "id": "CC-BY-NC-4.0", "name": "Creative Commons Attribution-NonCommercial 4.0 International", "short_name": "CC BY-NC 4.0", "url": "https://creativecommons.org/licenses/by-nc/4.0/", "summary": "credit the atlas, and do not use it commercially", "statement": "The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page.", "label": "Reuse terms: CC BY-NC 4.0", "about_path": "about/#reuse", "third_party_quotations": "Text quoted from a source stays under that source's own terms, given as the source's reuse_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third_party_quotations." }, "null_means": "Every field the schema defines is present. null means the record does not state it; it never means zero or none.", "schema": "downloads/15708f235d73cd42/schema.json", "records": { "atlas": { "id": "maternal", "name": "Maternal & Newborn Atlas", "scope": "Preconception; normal pregnancy and physiology; fetal development; pregnancy conditions; labor and childbirth; postpartum and lactation; premature and term newborn care; maternal mental health; infant follow-up and transition beyond neonatal care", "headline": "Pregnancy and newborn evidence, with who each claim applies to.", "lede": "This atlas connects conditions, treatments, studies and the organizations behind them. Pages start in plain words, and every result keeps its population, follow-up and source.", "theme": "sand-petrol", "sections": [ { "id": "explore", "label": "Explore", "description": "Search, conditions, care topics, technologies, interventions, products, comparison, graph explorer" }, { "id": "understand-care", "label": "Understand care", "description": "Prevention, symptoms/diagnosis, normal physiology, care pathways, biological pathways, glossary" }, { "id": "evidence-and-progress", "label": "Evidence & progress", "description": "Studies, publications, guidelines, results, historical timeline, evidence gaps and recent changes" }, { "id": "people-and-organizations", "label": "People & organizations", "description": "Researchers, clinicians, companies, institutions, journals, funders and datasets" }, { "id": "living-and-support", "label": "Living & support", "description": "Life-stage or condition reading guides, everyday impacts, recovery, rehabilitation, access and questions to ask" }, { "id": "open-questions", "label": "Open questions", "description": "Bottlenecks, existing efforts, hypotheses, proposed experiments and technology roadmaps" }, { "id": "about-and-contribute", "label": "About & contribute", "description": "Methodology, coverage, disclaimer, corrections, contributors, source licenses, API and downloads" } ], "navigation": [ { "id": "life-stage", "label": "Life stage", "description": "Browse by the stage of life a page is about, from before pregnancy to infant follow-up.", "terms": [ { "id": "preconception", "label": "Preconception", "description": "Health and care before a pregnancy begins." }, { "id": "pregnancy", "label": "Pregnancy", "description": "Health and care during pregnancy, for the mother and the fetus." }, { "id": "childbirth", "label": "Childbirth", "description": "Labor and birth." }, { "id": "postpartum", "label": "Postpartum", "description": "Health and care for the mother in the weeks after birth, including breastfeeding." }, { "id": "newborn", "label": "Newborn", "description": "Care for the baby in the newborn period, including babies born early or small." }, { "id": "infant-follow-up", "label": "Infant follow-up", "description": "Care for the baby after the newborn period, and the move beyond newborn care." } ] } ], "publication": "unreviewed", "base_url": "https://maternal.openmedicalatlas.org/" }, "entities": [ { "id": "core:blood-pressure", "owner": "core", "slug": "blood-pressure", "name": "Blood pressure", "aliases": [ "BP" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "How hard the blood pushes on the arteries and other blood vessels. Oscillometric blood pressure devices estimate a systolic value and a diastolic value.", "summary_technical": "MeSH descriptor D001794, Blood Pressure. Systolic and diastolic pressure are the two values that oscillometric devices estimate. Diagnostic thresholds and targets are not part of this identity. Each belongs in a cited claim about a named guideline edition.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [ { "namespace": "mesh", "value": "D001794" } ], "relationships": [], "navigation": { "cardio": { "system": [ "blood-vessels" ] } }, "kind": "biomarker", "payload": { "measure": "How hard the blood pushes on the arteries and other blood vessels. Oscillometric devices estimate it as a systolic value and a diastolic value.", "assay_context": null, "interpretation_claims": [] } }, { "id": "core:hypertension", "owner": "core", "slug": "hypertension", "name": "Hypertension (high blood pressure)", "aliases": [ "High blood pressure" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "Blood pressure that stays higher than it should over time.", "summary_technical": "Persistently raised arterial pressure. Diagnostic and treatment thresholds differ by guideline and measurement method, so each threshold or target must be cited to a specific guideline edition.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "cardio": { "system": [ "blood-vessels" ], "condition-area": [ "hypertension" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "core:home-bp-monitoring", "owner": "core", "slug": "home-bp-monitoring", "name": "Home blood pressure monitoring", "aliases": [ "Self-measured blood pressure monitoring", "SMBP", "HBPM" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "Measuring your own blood pressure with a device, at home or somewhere else outside the clinic.", "summary_technical": "Also called self-measured blood pressure (SMBP) monitoring. The CDC describes the patient measuring blood pressure regularly outside the clinic, at home or elsewhere, with a home device and at different times. The JACC panel says self-monitored blood pressure is frequently measured in the home and also in public places, so the home is one setting of it. MeSH has a concept named Blood Pressure Monitoring, Home (M0456886), filed under the descriptor Blood Pressure Monitoring, Ambulatory (D018660). That concept's label and scope note name only the home, so it is not an exact match and no MeSH id is recorded. Recommendations, accuracy and effects belong in cited claims.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "cardio": { "system": [ "blood-vessels" ] } }, "kind": "intervention", "payload": { "subtype": "test", "mechanism": "The person measures their own blood pressure with a home blood pressure device, at different points in time, outside the clinic.", "taxonomy_codes": [] } }, { "id": "core:lancet", "owner": "core", "slug": "lancet", "name": "The Lancet", "aliases": [ "Lancet" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "A medical journal published by Elsevier.", "summary_technical": "Crossref, the NLM Catalog and the ISSN Portal agree on the print ISSN 0140-6736 and the electronic ISSN 1474-547X, with ISSN-L 0140-6736. The NLM Catalog unique id is 2985213R.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [ { "namespace": "issn-print", "value": "0140-6736" }, { "namespace": "issn-electronic", "value": "1474-547X" }, { "namespace": "nlm-unique-id", "value": "2985213R" } ], "relationships": [], "navigation": null, "kind": "journal", "payload": { "publisher": "Elsevier", "scope": null } }, { "id": "core:nejm", "owner": "core", "slug": "nejm", "name": "The New England Journal of Medicine", "aliases": [ "N Engl J Med", "NEJM" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "A general medical journal that published the main reports of the SPRINT and iKMC trials.", "summary_technical": "Published by the Massachusetts Medical Society, per Crossref.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "journal", "payload": { "publisher": "Massachusetts Medical Society", "scope": null } }, { "id": "core:fda", "owner": "core", "slug": "fda", "name": "U.S. Food and Drug Administration", "aliases": [ "FDA", "United States Food and Drug Administration" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "The US federal agency that regulates drugs, biological products and medical devices, and that is also responsible for the safety of food and cosmetics.", "summary_technical": "A US federal agency with regulatory duties, housed in the Department of Health and Human Services. This identity states nothing about any decision. Device clearances and other decisions belong to the records that cite them.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [ { "namespace": "ror", "value": "034xvzb47" } ], "relationships": [], "navigation": null, "kind": "organization", "payload": { "roles": [ "regulator" ] } }, { "id": "core:outcome-death-any-cause", "owner": "core", "slug": "outcome-death-any-cause", "name": "Death from any cause", "aliases": [ "All-cause mortality" ], "atlases": [ "cardio", "maternal" ], "summary_plain": "Dying for any reason during a study's follow-up.", "summary_technical": "All-cause mortality. The time window belongs to each finding, not to this outcome.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Death from any cause", "unit": null, "components": [] } }, { "id": "core:automated-upper-arm-cuff-device", "owner": "core", "slug": "automated-upper-arm-cuff-device", "name": "Automated upper-arm cuff blood pressure device", "aliases": [], "atlases": [ "cardio", "maternal" ], "summary_plain": "A blood pressure device with a cuff for the upper arm that works out the reading itself from signals in the cuff.", "summary_technical": "The oscillometric method on the upper arm, as the JACC Scientific Expert Panel describes it. Automated follows the panel's meaning, in which a device can take several readings at set intervals from one start. The panel sets these apart from semi-automated devices, which need a manual start for every reading. FDA classifies noninvasive blood pressure measurement systems under product code DXN and 21 CFR 870.1130 as class II. That is a broader device type than this technology, so DXN is a broad mapping. This identity says nothing about the accuracy or validation of any device or the authorization of any product.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "cardio": { "system": [ "blood-vessels" ] } }, "kind": "technology", "payload": { "principle": "The device reads pulse waves in a cuff on the upper arm, usually while the cuff deflates, and a device-specific algorithm turns them into systolic and diastolic readings (the oscillometric method). An automated device can take several readings at set intervals from one start.", "taxonomy_codes": [ { "system": "FDA product code", "version": "classification page last updated 2026-10-05, shown on the page as 10/05/2026", "code": "DXN", "label": "system, measurement, blood-pressure, non-invasive" } ], "strengths": [ "An automated device can take several readings at set intervals with a single start." ], "limitations": [ "Each manufacturer uses its own undisclosed algorithm to estimate the readings.", "Even validated devices must be used in a standardized way, which includes a cuff of the right size that fits correctly and sits at heart level on a bare upper arm." ], "required_infrastructure": [] } }, { "id": "maternal:sflt1-plgf-ratio", "owner": "maternal", "slug": "sflt1-plgf-ratio", "name": "sFlt-1/PlGF ratio", "aliases": [ "sFlt-1 to PlGF ratio", "soluble fms-like tyrosine kinase-1 to placental growth factor ratio" ], "atlases": [ "maternal" ], "summary_plain": "A blood test result for a pregnant woman: two proteins, sFlt-1 and placental growth factor (PlGF), are measured in the same sample, and the first is divided by the second. The test is used in two different ways in two countries. In the United States, the FDA clears one version as an aid for judging, within two weeks, the risk of pre-eclampsia with severe features (the FDA term) in women already in hospital with high blood pressure, and the FDA regulation for prognostic tests of this kind says they are not intended for diagnosis. In England, NICE recommends two named ratio tests (DELFIA Xpress and Elecsys) and two PlGF-only tests to help rule pre-eclampsia in or out when it is suspected between 20 weeks and 36 weeks and 6 days, and does not recommend a third ratio test, the BRAHMS Kryptor ratio, for routine NHS use. The two uses are not interchangeable.", "summary_technical": "The ratio of soluble fms-like tyrosine kinase-1 (sFlt-1) to placental growth factor (PlGF) measured by a matched pair of immunoassays, in human serum (Elecsys) or in serum or K2-EDTA plasma (KRYPTOR). Interpretation depends on the stated intended use. US: 21 CFR 862.1602 describes a prognostic aid device type for the development or progression of pre-eclampsia and says that device is not intended for diagnosis; the K241453 indication covers singleton pregnancies at 23+0 to 34+6/7 weeks hospitalized for a hypertensive disorder of pregnancy, with progression to pre-eclampsia with severe features within two weeks from testing. England: in NICE HTG630 the Elecsys company labelling is reported to present the test as an aid to diagnosing pre-eclampsia and to predicting it in the short term, with cut-offs that depend on use and stage of pregnancy. A cut-off printed in one document must not be applied to the other document's use. This record gives no cut-off as a general rule.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "related_to", "object": "maternal:preeclampsia", "claim": null, "label": "Measured in blood tests that NICE and the FDA each describe for pre-eclampsia, for different uses" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "biomarker", "payload": { "measure": "Ratio of the sFlt-1 concentration to the PlGF concentration in a single sample (serum for the Elecsys pair, serum or K2-EDTA plasma for the KRYPTOR pair), from two paired immunoassays.", "assay_context": "Laboratory immunoassays on an automated analyzer. Roche's K241453 510(k) Summary says values from other manufacturers' assays \"may result in significantly different ratios\" and that only the Elecsys sFlt-1 and Elecsys PlGF assays should be used to calculate the Elecsys ratio. Uses and cut-offs differ by jurisdiction and are kept in separate claims and contexts.", "interpretation_claims": [ "maternal:claim-sflt1-plgf-ratio-us-prognostic-use", "maternal:claim-sflt1-plgf-ratio-nice-rule-in-out-use" ] } }, { "id": "maternal:bottleneck-pph-detection", "owner": "maternal", "slug": "bottleneck-pph-detection", "name": "Late detection of postpartum haemorrhage", "aliases": [ "PPH detection gap" ], "atlases": [ "maternal" ], "summary_plain": "Heavy bleeding after birth is often missed or noticed late when blood loss is judged by eye, which is frequently inaccurate. The response WHO now recommends is to measure blood loss objectively and to start a standard set of treatments straight away.", "summary_technical": "WHO says visual estimation is frequently inaccurate, so PPH often goes unrecognised or is identified too late for a life-saving intervention. WHO also says life-saving interventions may be used inconsistently or deployed late because of delayed diagnosis. The two WHO burden figures (2023 and 2025) have different bases and stay separate. Current efforts listed here are an objective-measurement tool, a package that pairs measurement with treatment, and WHO itself as the issuer of the recommendations.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ] } }, "kind": "bottleneck", "payload": { "stage": "Detection and diagnosis in the first hours after birth", "scope": "Women giving birth, with the strongest evidence for vaginal birth in secondary-level facilities; the burden is concentrated in low- and middle-income countries.", "severity_rationale": "Delays in detection or treatment can result in complications or death (E-MOTIVE abstract); WHO says deaths from PPH are largely preventable but the interventions are used inconsistently or late.", "burden_claims": [ "maternal:claim-who-2023-burden", "maternal:claim-who-2025-burden" ], "current_efforts": [ "maternal:calibrated-blood-collection-drape", "maternal:pph-detection-and-first-response-bundle", "maternal:who" ] } }, { "id": "maternal:newborn-thermal-care", "owner": "maternal", "slug": "newborn-thermal-care", "name": "Newborn thermal care", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Keeping a newborn warm and preventing a low body temperature.", "summary_technical": "Prevention and management of low body temperature (hypothermia) in newborns. The iKMC trial measured hypothermia as a secondary outcome, using its own definition. The WHO 2022 preterm and low-birth-weight guideline lists thermal care as covered by separate WHO guidance, which this atlas does not yet record.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "care_topic", "payload": { "scope": "Prevention and management of low body temperature in newborns", "life_stages": [ "newborn" ], "care_setting": null } }, { "id": "maternal:preterm-lbw-care", "owner": "maternal", "slug": "preterm-lbw-care", "name": "Care of the preterm or low-birth-weight infant", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The care of a baby born early or small, from birth through the first two years. It includes skin-to-skin care with a parent, feeding with the mother's own milk, breathing support when it is needed, keeping the baby warm, and support for the family in hospital and after going home.", "summary_technical": "WHO scope (2022): infants born before 37 weeks or weighing under 2.5 kg, in any health-care facility or community setting, from birth to 24 months of age. The WHO guideline has 25 recommendations and one good practice statement in three groups: preventive and promotive care, care for complications, and family involvement and support. The atlas records the WHO immediate KMC recommendation (A.1b) on the immediate KMC page; records for the other recommendations are not yet written.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "related_to", "object": "maternal:newborn-thermal-care", "claim": null, "label": "Related care topic" }, { "predicate": "related_to", "object": "maternal:kangaroo-mother-care", "claim": null, "label": "Skin-to-skin care for small and early babies" }, { "predicate": "related_to", "object": "maternal:preterm-birth", "claim": null, "label": "The WHO guideline on this care covers infants born before 37 weeks of gestation" }, { "predicate": "related_to", "object": "maternal:low-birth-weight", "claim": null, "label": "The WHO guideline on this care covers infants weighing under 2.5 kg" } ], "navigation": { "maternal": { "life-stage": [ "newborn", "infant-follow-up" ] } }, "kind": "care_topic", "payload": { "scope": "Care of preterm (under 37 weeks) or low-birth-weight (under 2.5 kg) infants from birth to 24 months of age, covering preventive and promotive care, care for complications, and family involvement and support", "life_stages": [ "newborn", "infant follow-up" ], "care_setting": null } }, { "id": "maternal:chronic-hypertension-in-pregnancy", "owner": "maternal", "slug": "chronic-hypertension-in-pregnancy", "name": "Chronic hypertension in pregnancy", "aliases": [ "Chronic hypertension" ], "atlases": [ "maternal" ], "summary_plain": "High blood pressure that a woman already has when she becomes pregnant, or that is found in the first 20 weeks. It is a form of high blood pressure, but decisions in pregnancy differ: some blood pressure medicines are not advised, and whether to treat mildly raised pressure has been debated.", "summary_technical": "Pre-existing or early-pregnancy hypertension. NICE NG133 (terms used): high blood pressure that is found at the first antenatal (booking) appointment or before 20 weeks, or that a woman is already on medicine for when she is referred to maternity care; it can be primary or secondary. NG133 treats a systolic pressure of 140 mmHg or more, or a diastolic pressure of 90 mmHg or more, as hypertension. The CHAP trial used its own entry definition, given on the CHAP trial page, which is close to NICE’s but not identical. NG133 advises stopping ACE inhibitors or ARBs if a woman becomes pregnant. CHAP’s authors describe treatment of mild chronic hypertension in pregnancy as controversial before the trial. Pre-eclampsia can develop in women who have chronic hypertension (NG133 1.3.12). The recipient is the pregnant woman; effects on the fetus or newborn sit in claims with their own contexts.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "subtype_of", "object": "maternal:hypertensive-disorders-of-pregnancy", "claim": null, "label": "One of the three groups NICE lists under hypertensive disorders of pregnancy" }, { "predicate": "related_to", "object": "core:hypertension", "claim": null, "label": "Hypertension that is present before or early in pregnancy" } ], "navigation": { "maternal": { "life-stage": [ "preconception", "pregnancy", "postpartum" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "maternal:hypertensive-disorders-of-pregnancy", "owner": "maternal", "slug": "hypertensive-disorders-of-pregnancy", "name": "Hypertensive disorders of pregnancy", "aliases": [ "Hypertension in pregnancy", "HDP" ], "atlases": [ "maternal" ], "summary_plain": "High blood pressure that is present before pregnancy or starts during it. NICE groups these disorders in three ways: high blood pressure that was there before pregnancy or appeared in the first 20 weeks (chronic hypertension), new high blood pressure that starts in the second half of pregnancy (called gestational hypertension), and new high blood pressure with signs that other organs are affected (pre-eclampsia). NICE puts the share of pregnant women affected at about 8% to 10%.", "summary_technical": "Umbrella for chronic hypertension, gestational hypertension and pre-eclampsia, as the NICE guideline NG133 groups them in its Context chapter. NG133 treats a systolic pressure of 140 mmHg or more, or a diastolic pressure of 90 mmHg or more, as hypertension, and gestational hypertension as high blood pressure that starts after 20 weeks of pregnancy with no significant protein in the urine. This atlas has records for chronic hypertension in pregnancy and for pre-eclampsia; gestational hypertension has no record of its own yet. Some guidance applies to the whole group (NG133 recommendations 1.9 and 1.10, and WHO 2020 for non-severe hypertension), which is why this umbrella exists. NG133 notes that its update did not review treatment for the three types of hypertension in pregnancy as one group. The maternal context is the default here; effects on the fetus or newborn sit in claims with their own contexts. WHO’s 2020 guideline says they are behind about 14% of maternal deaths around the world.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "increases_risk_of", "object": "core:hypertension", "claim": "maternal:claim-nice-ng133-1-10-2-later-cvd", "label": "Hypertensive disorders of pregnancy are associated with a higher later risk of hypertension and cardiovascular disease (NICE NG133 1.10.2)" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy", "postpartum" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "maternal:low-birth-weight", "owner": "maternal", "slug": "low-birth-weight", "name": "Low birth weight", "aliases": [ "LBW" ], "atlases": [ "maternal" ], "summary_plain": "A baby who is born small. The exact weight threshold depends on the source and is not recorded here yet.", "summary_technical": "Birth weight below a defined threshold. This atlas does not yet record the general definition, so each study's birth-weight band (for example 1.0 to under 1.8 kg) is kept with that study's context.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "maternal:postpartum-hemorrhage", "owner": "maternal", "slug": "postpartum-hemorrhage", "name": "Postpartum haemorrhage", "aliases": [ "Postpartum hemorrhage", "PPH" ], "atlases": [ "maternal" ], "summary_plain": "Heavy bleeding after a baby is born. It is one of the most common complications of childbirth. It is also a leading cause of death for mothers worldwide, and most of those deaths happen in low- and middle-income countries.", "summary_technical": "Two definitions appear in this atlas and each belongs to its source. WOMAN let hospitals treat a woman as having PPH on a clinical diagnosis, based on estimated blood loss of more than 500 mL after vaginal birth or 1000 mL after caesarean section, or any loss that compromised haemodynamic stability. That is the trial eligibility wording, not WHO wording. WHO 2025 Recommendation 22 gives a \"therapeutic definition\" meant to start treatment, built on objectively measured blood loss: 300 mL or more with any abnormal haemodynamic sign, or 500 mL or more, whichever occurs first within 24 hours after birth. The older rule of thumb is a loss of more than 500 mL within 24 hours. The two burden figures from WHO (2023 and 2025) have different bases and are kept as separate claims.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": "Bleeding is often noticed late when blood loss is judged by eye. WHO says visual estimation is frequently inaccurate and recommends measuring blood loss objectively (Recommendation 21).", "assessment": "WHO 2025 Recommendation 22 uses objectively measured loss of 300 mL or more with any abnormal haemodynamic sign (pulse above 100 beats a minute, shock index above 1, systolic pressure below 100 mmHg or diastolic pressure below 60 mmHg), or 500 mL or more, whichever occurs first within 24 hours after birth, with particular vigilance during the first 2 hours.", "burden_claims": [ "maternal:claim-who-2023-burden", "maternal:claim-who-2025-burden" ] } }, { "id": "maternal:preeclampsia", "owner": "maternal", "slug": "preeclampsia", "name": "Pre-eclampsia", "aliases": [ "Preeclampsia" ], "atlases": [ "maternal" ], "summary_plain": "A condition of pregnancy in which blood pressure rises after 20 weeks and, at the same time, there are signs that other parts of the body are affected. These can include protein in the urine, or problems with the kidneys, liver, blood or brain, or with the placenta and the baby’s growth.", "summary_technical": "NICE NG133 (terms used) defines it as high blood pressure first seen after 20 weeks of pregnancy, above 140 mmHg systolic or above 90 diastolic, together with at least one new problem: protein in the urine, or dysfunction of the kidneys, liver, nervous system or blood, or of the uteroplacental unit (for example poor fetal growth, abnormal umbilical artery doppler results or stillbirth). Other guidelines and trials define it differently; the CHAP trial used ACOG criteria, and this atlas has not compared the two. Pre-eclampsia can develop in women who have chronic hypertension (NG133 1.3.12; CHAP registry description). The recipient is the pregnant woman; fetal and newborn consequences sit in claims with their own contexts.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "subtype_of", "object": "maternal:hypertensive-disorders-of-pregnancy", "claim": null, "label": "One of the three groups NICE lists under hypertensive disorders of pregnancy" }, { "predicate": "related_to", "object": "maternal:chronic-hypertension-in-pregnancy", "claim": null, "label": "Pre-eclampsia can develop in women who already have chronic hypertension" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy", "postpartum" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "maternal:preterm-birth", "owner": "maternal", "slug": "preterm-birth", "name": "Preterm birth", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Birth before 37 completed weeks of pregnancy. The term covers two things: the baby who is born early, and the pregnancy that is likely to end early. WHO writes its advice on steroid injections before an early birth for women who are likely to give birth early, and its advice on the care of the baby for babies born early.", "summary_technical": "WHO 2022 (antenatal corticosteroid guideline) defines preterm birth as \"a baby born prior to 37 completed weeks of gestation\". WHO 2022 (care of the preterm or low-birthweight infant) writes the preterm infant as under 37 weeks of gestation. The cut-off is WHO’s. Claims on this record state their recipient and keep the sides apart. For treatment given to the woman before the birth, the WHO recommendation is about women with a high likelihood of preterm birth (maternal recipient), while the ACTION-I result counts the newborn’s deaths (newborn recipient). Claims about the care of the baby after the birth concern the baby born early (WHO immediate kangaroo mother care). Other definitions, subdivisions by gestational age and causes are not recorded here.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "pregnancy", "childbirth", "newborn" ] } }, "kind": "condition", "payload": { "taxonomy_codes": [], "recognition": null, "assessment": null, "burden_claims": [] } }, { "id": "maternal:idea-immediate-kmc-high-resource-nicu", "owner": "maternal", "slug": "idea-immediate-kmc-high-resource-nicu", "name": "Immediate KMC in high-resource neonatal intensive care units", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "An untested question. Starting skin-to-skin care right after birth lowered deaths of small babies in the WHO iKMC trial, which ran in five hospitals in Africa and India. Would it also help small babies in well-equipped intensive care units? The trial's authors say this is not yet known.", "summary_technical": "Hypothesis, not a result. The iKMC authors write that further studies in well-resourced settings could help determine whether the survival results are relevant to low-mortality settings with intensive infant monitoring. No test in a high-resource unit is recorded in this atlas.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "related_to", "object": "maternal:immediate-kmc", "claim": null, "label": "Asks whether immediate KMC also helps in high-resource units" }, { "predicate": "related_to", "object": "maternal:ikmc-study", "claim": null, "label": "Builds on the iKMC trial" } ], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "idea", "payload": { "hypothesis": "In high-resource neonatal intensive care units, starting continuous skin-to-skin care immediately after birth, before stabilization, would lower death or illness among infants of 1.0 to under 1.8 kg compared with starting it after stabilization.", "rationale": "The iKMC trial found fewer deaths with immediate KMC in five tertiary hospitals in Ghana, India, Malawi, Nigeria and Tanzania. Its authors say that relevance to low-mortality settings with intensive infant monitoring is not known.", "test": "A randomized comparison of immediate with after-stabilization KMC in a high-resource unit, in infants of 1.0 to under 1.8 kg. None is recorded here.", "maturity": "concept", "proponents": [], "objections": [ "The iKMC authors say the benefit cannot be split between immediate starting and the mother's continuous presence, because both are part of the intervention.", "High-resource units have intensive monitoring and a different level of mortality, so the low-resource result may not carry over." ] } }, { "id": "maternal:antenatal-corticosteroids", "owner": "maternal", "slug": "antenatal-corticosteroids", "name": "Antenatal corticosteroids", "aliases": [ "Antenatal glucocorticoids" ], "atlases": [ "maternal" ], "summary_plain": "Steroid medicines, dexamethasone or betamethasone, given by injection to a pregnant woman who is likely to give birth early. The medicine reaches the baby and helps the lungs mature, which can protect the baby's breathing after an early birth. The mother receives the medicine and the baby is the one who is meant to benefit.", "summary_technical": "Glucocorticoids given to women with a high likelihood of preterm birth. WHO 2022 recommends intramuscular dexamethasone or betamethasone, total 24 mg in divided doses (Recommendation 1.9). ACTION-I gave intramuscular dexamethasone 6 mg every 12 hours for up to four doses, against placebo, in 29 hospitals in five low-resource countries. The recipient is the woman and the outcome of interest is the infant's, so each claim on this page states both.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "recommended_for", "object": "maternal:preterm-birth", "claim": "maternal:claim-who-2022-acs-1-0", "label": "WHO 2022 Recommendation 1.0 (context-specific): for women with a high likelihood of preterm birth from 24 to 34 weeks, when five conditions are met" }, { "predicate": "evaluated_for", "object": "maternal:preterm-birth", "claim": "maternal:claim-action-i-neonatal-death", "label": "Tested in ACTION-I: given to the mother, outcome counted in the infant (death by 28 days)" }, { "predicate": "related_to", "object": "maternal:preterm-lbw-care", "claim": null, "label": "Care of the preterm newborn after birth" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "intervention", "payload": { "subtype": "medicine", "mechanism": "Per WHO 2022, the glucocorticoid crosses the placenta and helps the fetal lungs mature, including faster production of surfactant, which can prevent breathing-related illness and death in preterm newborns.", "taxonomy_codes": [] } }, { "id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "owner": "maternal", "slug": "antihypertensive-treatment-non-severe-hypertension-pregnancy", "name": "Antihypertensive drug treatment for non-severe hypertension in pregnancy", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Using blood pressure medicines in pregnancy when blood pressure is raised but not yet severe, instead of waiting until it becomes severe. This is a treatment strategy, not one drug. Different sources use different cut-offs and targets, so each target is kept with the claim that reports it.", "summary_technical": "Strategy of drug treatment for non-severe hypertension in pregnancy. CHAP treated mild chronic hypertension to a goal below 140/90 mm Hg, compared with treatment only if severe hypertension developed (systolic 160 or diastolic 105 mm Hg or higher); first-line drugs were labetalol or extended-release nifedipine. NICE NG133 1.3.9 gives a target of 135/85 mmHg whenever medicines are used to treat hypertension in pregnancy, and its management tables for gestational hypertension and pre-eclampsia say 135/85 mmHg or less. WHO 2020 recommends offering drug treatment for non-severe hypertension (140 to 159 systolic and/or 90 to 109 diastolic) with no numeric target. WHO also says calcium channel blockers should be avoided, and WHO’s evidence summary lists nifedipine among the calcium channel blockers, while CHAP used extended-release nifedipine as first line; the atlas records this difference and does not reconcile it. The WHO 2020 recommendation predates the CHAP report (2022). Targets belong to each claim’s context.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "evaluated_for", "object": "maternal:chronic-hypertension-in-pregnancy", "claim": "maternal:claim-chap-primary-composite", "label": "Evaluated in CHAP against a combined measure of serious pregnancy problems, in women with mild chronic hypertension" }, { "predicate": "evaluated_for", "object": "maternal:preeclampsia", "claim": "maternal:claim-chap-any-preeclampsia", "label": "Evaluated in CHAP for pre-eclampsia in women with mild chronic hypertension" }, { "predicate": "recommended_for", "object": "maternal:hypertensive-disorders-of-pregnancy", "claim": "maternal:claim-nice-ng133-1-3-9-target", "label": "NICE NG133 1.3.9: target of 135/85 mmHg when medicines are used to treat hypertension in pregnancy" }, { "predicate": "recommended_for", "object": "maternal:hypertensive-disorders-of-pregnancy", "claim": "maternal:claim-who-2020-nonsevere-htn", "label": "WHO 2020: offer drug treatment when hypertension in pregnancy is non-severe (context-specific recommendation)" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "intervention", "payload": { "subtype": "medicine", "mechanism": null, "taxonomy_codes": [] } }, { "id": "maternal:immediate-kmc", "owner": "maternal", "slug": "immediate-kmc", "name": "Immediate kangaroo mother care", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Starting skin-to-skin care within hours of birth, even before a small baby is fully stable, with the mother staying in the newborn unit.", "summary_technical": "KMC started as soon as possible after birth, before clinical stabilization. WHO's evidence review counts KMC started within 24 hours of birth as early. In the iKMC trial it was delivered in a Mother-NICU.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "subtype_of", "object": "maternal:kangaroo-mother-care", "claim": null, "label": "KMC started as soon as possible after birth" }, { "predicate": "evaluated_for", "object": "maternal:low-birth-weight", "claim": "maternal:claim-ikmc-28d-mortality", "label": "Evaluated in iKMC for death by 28 days, in infants of 1.0 to under 1.8 kg" }, { "predicate": "recommended_for", "object": "maternal:low-birth-weight", "claim": "maternal:claim-who-a1b-immediate-kmc", "label": "WHO 2022 A.1b: strong recommendation, high-certainty evidence" }, { "predicate": "recommended_for", "object": "maternal:preterm-birth", "claim": "maternal:claim-who-a1b-immediate-kmc", "label": "WHO 2022 A.1b: strong recommendation, high-certainty evidence" } ], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "intervention", "payload": { "subtype": "service", "mechanism": null, "taxonomy_codes": [] } }, { "id": "maternal:kangaroo-mother-care", "owner": "maternal", "slug": "kangaroo-mother-care", "name": "Kangaroo mother care (KMC)", "aliases": [ "KMC" ], "atlases": [ "maternal" ], "summary_plain": "Holding the baby skin-to-skin on the mother's chest for long periods, together with breastfeeding.", "summary_technical": "WHO describes KMC as early, continuous and prolonged skin-to-skin contact between the mother (or another caregiver) and the baby, with exclusive breastfeeding (WHO 2022, A.1 Background).", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "related_to", "object": "maternal:newborn-thermal-care", "claim": null, "label": "Related care topic" } ], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "intervention", "payload": { "subtype": "service", "mechanism": null, "taxonomy_codes": [] } }, { "id": "maternal:low-dose-aspirin-preeclampsia-prevention", "owner": "maternal", "slug": "low-dose-aspirin-preeclampsia-prevention", "name": "Low-dose aspirin to prevent pre-eclampsia", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A small daily dose of aspirin taken during pregnancy by women at higher risk of pre-eclampsia, to help prevent it. In England, NICE tells clinicians to advise 75 mg to 150 mg a day, from 12 weeks of pregnancy until the birth, for women at high risk and for women with more than one moderate risk factor. NICE notes that for this use aspirin has to be prescribed, and that community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine. WHO gives different advice: 75 mg a day for women at moderate or high risk, using its own lists of risk factors.", "summary_technical": "Aspirin (acetylsalicylic acid) at 75 mg to 150 mg daily from week 12 of pregnancy to the birth, as in NICE NG133 recommendations 1.1.2 and 1.1.3, both marked [2010, amended 2019]. The NICE page notes that at publication in June 2019 aspirin had no UK marketing authorisation, and says that community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine, and that aspirin for this use must be prescribed. A recommendation is not an authorization. WHO 2021 recommends 75 mg per day for women at moderate or high risk and says treatment should start by 20 weeks or as soon as antenatal care starts (WHO labels this a \"Context-specific recommendation\"). The risk lists, doses and start times differ between issuers, so each is kept in its own claim and context. NICE NG133 gives no effect size; this record does not state one.", "editorial_state": "draft", "last_substantive_edit": "2026-10-13", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "recommended_for", "object": "maternal:preeclampsia", "claim": "maternal:claim-nice-ng133-1-1-2-aspirin-high-risk", "label": "NICE NG133 1.1.2: 75 to 150 mg daily from 12 weeks for women at high risk (any one of five listed factors)" }, { "predicate": "recommended_for", "object": "maternal:preeclampsia", "claim": "maternal:claim-nice-ng133-1-1-3-aspirin-moderate-risk", "label": "NICE NG133 1.1.3: 75 to 150 mg daily from 12 weeks for women with more than one of six moderate risk factors" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "intervention", "payload": { "subtype": "medicine", "mechanism": null, "taxonomy_codes": [] } }, { "id": "maternal:objective-blood-loss-measurement", "owner": "maternal", "slug": "objective-blood-loss-measurement", "name": "Objective measurement of postpartum blood loss", "aliases": [ "Objective blood-loss measurement" ], "atlases": [ "maternal" ], "summary_plain": "Measuring the blood a woman loses after birth with a tool, instead of judging it by eye. WHO recommends doing this for every woman giving birth, and uses measured amounts in its criteria for deciding when to start treatment.", "summary_technical": "WHO 2025 Recommendation 21 (Revalidated, Recommended) recommends routine objective measurement for all women giving birth; calibrated drapes at vaginal birth are named as one method. Recommendation 22 (New, Recommended) gives the diagnostic criteria built on measured loss: 300 mL or more with any abnormal haemodynamic sign, or 500 mL or more, whichever occurs first within 24 hours after birth. WHO says measurement is effective only when linked to a standardized treatment protocol.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "uses_technology", "object": "maternal:calibrated-blood-collection-drape", "claim": null, "label": "Calibrated drapes are the named method for vaginal birth" }, { "predicate": "recommended_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-who-2025-pph-21-objective-measurement", "label": "WHO 2025 Recommendation 21: recommended for all women giving birth" } ], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ] } }, "kind": "intervention", "payload": { "subtype": "test", "mechanism": "Quantifies blood loss objectively, for example with a calibrated drape after vaginal birth, so bleeding is detected sooner than with visual estimation.", "taxonomy_codes": [] } }, { "id": "maternal:plgf-based-testing", "owner": "maternal", "slug": "plgf-based-testing", "name": "PlGF-based testing for suspected preterm pre-eclampsia", "aliases": [ "PLGF-based testing" ], "atlases": [ "maternal" ], "summary_plain": "A blood test for placental growth factor (PlGF), alone or as a ratio with a second protein, used together with a clinician's usual assessment when pre-eclampsia is suspected before 37 weeks (preterm). NICE in England recommends four named tests to help rule pre-eclampsia in or out between 20 weeks and 36 weeks and 6 days. NICE recommends against using the tests to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia.", "summary_technical": "The intervention NICE HTG630 (formerly DG49) recommends in recommendation 1.1: four named tests, to be used alongside the usual clinical assessment, two measuring PLGF alone (DELFIA Xpress PLGF 1-2-3 and Triage PLGF Test) and two using the sFlt-1/PLGF ratio (DELFIA Xpress sFlt-1/PLGF 1-2-3 ratio and Elecsys immunoassay sFlt-1/PLGF ratio). Each test is to be used within its manufacturer's stated indications for use, and some manufacturers do not indicate their tests for the whole gestational range. Recommendations 1.4 and 1.5 limit the use. This record is the NICE intervention only. It is not the US FDA-cleared use of the Elecsys test, which has a different stated purpose and population.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "related_to", "object": "maternal:sflt1-plgf-immunoassay", "claim": null, "label": "Two of the four NICE-recommended tests use the sFlt-1/PlGF ratio; two measure PlGF alone" }, { "predicate": "recommended_for", "object": "maternal:preeclampsia", "claim": "maternal:claim-nice-htg630-1-1", "label": "NICE HTG630 1.1: used with standard clinical assessment to help rule pre-eclampsia in or out when preterm pre-eclampsia is suspected (20 weeks to 36 weeks 6 days)" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "intervention", "payload": { "subtype": "test", "mechanism": null, "taxonomy_codes": [] } }, { "id": "maternal:pph-detection-and-first-response-bundle", "owner": "maternal", "slug": "pph-detection-and-first-response-bundle", "name": "PPH detection and first-response treatment bundle", "aliases": [ "E-MOTIVE package", "MOTIVE bundle" ], "atlases": [ "maternal" ], "summary_plain": "A package for hospitals. Staff measure blood loss at vaginal births with a calibrated drape, and when heavy bleeding is detected they start a standard set of treatments straight away. The set covers uterine massage, a uterus-contracting medicine, tranexamic acid, fluids into a vein, a check for the source of bleeding and calling for more help. Staff training and feedback support the package.", "summary_technical": "The package combines objective blood-loss assessment with a calibrated drape, a first-response bundle (uterine massage, an oxytocic drug, tranexamic acid, intravenous fluids, examination of the genital tract and escalation of care) and an implementation strategy. WHO 2025 Recommendation 29 (Revalidated, Recommended) recommends it for all women having a vaginal birth. E-MOTIVE tested the whole package; the drape alone was not tested, and the effect cannot be assigned to any component. WHO says the supporting evidence comes largely from vaginal births in secondary-level facilities and that more research is needed before recommending bundle care at caesarean birth.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "uses_technology", "object": "maternal:calibrated-blood-collection-drape", "claim": null, "label": "Uses a calibrated drape for early detection" }, { "predicate": "requires", "object": "maternal:objective-blood-loss-measurement", "claim": null, "label": "Detection depends on measured blood loss" }, { "predicate": "requires", "object": "maternal:tranexamic-acid-pph-treatment", "claim": null, "label": "Tranexamic acid is one part of the treatment bundle" }, { "predicate": "recommended_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-who-2025-pph-29-bundle", "label": "WHO 2025 Recommendation 29: recommended for vaginal birth" }, { "predicate": "evaluated_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-emotive-detection", "label": "Evaluated as a package in E-MOTIVE" } ], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ] } }, "kind": "intervention", "payload": { "subtype": "service", "mechanism": "Early objective detection triggers a coordinated set of treatments, supported by training, audit and feedback and an emergency supply trolley or carry case (implementation strategy).", "taxonomy_codes": [] } }, { "id": "maternal:tranexamic-acid-pph-treatment", "owner": "maternal", "slug": "tranexamic-acid-pph-treatment", "name": "Tranexamic acid for treating postpartum haemorrhage", "aliases": [ "TXA for PPH treatment", "Tranexamic acid" ], "atlases": [ "maternal" ], "summary_plain": "A medicine given into a vein, on top of usual care, to women who are bleeding heavily after birth. It works by slowing the breakdown of blood clots. In the WOMAN trial it lowered deaths from bleeding but did not clearly change deaths from all causes or hysterectomy. WHO recommends giving it early, within 3 hours of birth. This page is about treating bleeding that has started. WHO 2025 does not recommend the medicine to prevent bleeding in women who are not bleeding heavily.", "summary_technical": "Added to standard care as 1 g (100 mg/mL) intravenously at 1 mL per minute, with a second 1 g dose if bleeding continues after 30 minutes or restarts within 24 hours, as in WOMAN and as supported by WHO 2025 Recommendation 27. The overall WOMAN result covers all treatment times; the within-3-hours result is a pre-specified subgroup with its own claim and context. WHO 2025 Recommendations 14 and 15 do not recommend it for prevention at vaginal or caesarean birth; that is a different use with its own claim and context, and treatment evidence does not transfer to it. No treats relationship is recorded: the claims and the WHO recommendation say what is known, and a clinical reviewer can decide whether a stronger link is warranted.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "evaluated_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-woman-death-due-to-bleeding", "label": "Evaluated in WOMAN for death due to bleeding" }, { "predicate": "evaluated_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-woman-composite-primary", "label": "Evaluated in WOMAN for death or hysterectomy, with no clear difference" }, { "predicate": "recommended_for", "object": "maternal:postpartum-hemorrhage", "claim": "maternal:claim-who-2025-pph-27-txa", "label": "WHO 2025 Recommendation 27: recommended, within 3 hours of birth" } ], "navigation": { "maternal": { "life-stage": [ "postpartum" ] } }, "kind": "intervention", "payload": { "subtype": "medicine", "mechanism": "Inhibits the enzymatic breakdown of fibrinogen and fibrin by plasmin (WOMAN introduction).", "taxonomy_codes": [] } }, { "id": "maternal:gates-foundation", "owner": "maternal", "slug": "gates-foundation", "name": "Bill & Melinda Gates Foundation", "aliases": [ "Bill and Melinda Gates Foundation" ], "atlases": [ "maternal" ], "summary_plain": "A private foundation that funds global health research.", "summary_technical": "Funder of the WHO Immediate KMC Study according to the abstract funding statement, the ANZCTR funding source and the ICTRP funding field.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "organization", "payload": { "roles": [ "funder" ] } }, { "id": "maternal:nhlbi", "owner": "maternal", "slug": "nhlbi", "name": "National Heart, Lung, and Blood Institute (NHLBI)", "aliases": [ "NHLBI" ], "atlases": [ "maternal" ], "summary_plain": "A research institute of the US National Institutes of Health that works on heart, lung, blood and sleep disorders. It funded the CHAP trial.", "summary_technical": "One of the institutes of the National Institutes of Health. Funder of the CHAP trial (Chronic Hypertension and Pregnancy) according to the funding statement in the PubMed abstract.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "organization", "payload": { "roles": [ "funder" ] } }, { "id": "maternal:nice", "owner": "maternal", "slug": "nice", "name": "National Institute for Health and Care Excellence (NICE)", "aliases": [ "NICE" ], "atlases": [ "maternal" ], "summary_plain": "An organization that writes guidance for health and care practitioners. Here it is the issuer of two pieces of guidance: the guideline on hypertension in pregnancy (NG133) and the HealthTech guidance on tests based on placental growth factor (PlGF) for suspected preterm pre-eclampsia (HTG630, formerly DG49).", "summary_technical": "Issuer of every NICE document the atlas cites. NICE guideline NG133 (Hypertension in pregnancy: diagnosis and management) is behind the recommendations on aspirin and the blood pressure target. NICE HealthTech guidance HTG630 (PLGF-based testing to help diagnose suspected preterm pre-eclampsia, formerly diagnostics guidance DG49) is behind the recommendation on PlGF-based testing. The institution role is a placeholder that the schema requires. The fetched pages do not state NICE’s jurisdiction, so the atlas does not attach one to NICE itself. Each NICE decision record states the jurisdiction it uses. Whether NICE becomes a shared core identity is open (the request for core:nice is in requests/shared-core-identities.md): the cardiovascular atlas holds its own cardio:nice.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "organization", "payload": { "roles": [ "institution" ] } }, { "id": "maternal:who", "owner": "maternal", "slug": "who", "name": "World Health Organization", "aliases": [ "WHO" ], "atlases": [ "maternal" ], "summary_plain": "The United Nations agency for international public health.", "summary_technical": "Primary sponsor of the WHO Immediate KMC Study (ANZCTR, ICTRP) and issuer of the 2022 guideline on care of the preterm or low-birth-weight infant. It also issued postpartum haemorrhage guidance: the 2017 recommendation on tranexamic acid for treatment, the 2023 recommendations on assessing blood loss and on a treatment bundle, and the 2025 consolidated guideline on prevention, diagnosis and treatment. The institution role is a placeholder that the schema requires.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "addresses", "object": "maternal:bottleneck-pph-detection", "claim": null, "label": "Issued the 2023 and 2025 recommendations on objective blood-loss measurement" } ], "navigation": null, "kind": "organization", "payload": { "roles": [ "institution" ] } }, { "id": "maternal:outcome-chap-any-preeclampsia", "owner": "maternal", "slug": "outcome-chap-any-preeclampsia", "name": "Any pre-eclampsia (CHAP definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the mother developed pre-eclampsia, with or without severe features, during the trial.", "summary_technical": "CHAP secondary outcome, defined by ACOG criteria. It overlaps with the pre-eclampsia-with-severe-features part of the primary composite, so the two must not be added together. The recipient is the mother.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Preeclampsia, with or without severe features, defined according to ACOG criteria.", "unit": "patients", "components": [] } }, { "id": "maternal:outcome-chap-fetal-or-neonatal-death", "owner": "maternal", "slug": "outcome-chap-fetal-or-neonatal-death", "name": "Fetal or neonatal death (CHAP definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the baby died before birth or soon after birth. It is one of the four parts of the CHAP primary combined outcome, which counts fetal and newborn deaths together.", "summary_technical": "One of the four components of maternal:outcome-chap-primary-composite, worded as the CHAP paper's Methods words it. The paper's Methods name it without a definition. The time window differs between the sources and is not reconciled here: the paper's Table 2 row reads fetal or neonatal death at under 28 days, and the registry reads fetal death or neonatal death up to discharge or 90 days if prior. The statistical analysis plan attached to the registry record (v2.2) defines the component as fetal or neonatal death within 28 days, and the attached protocol (v1.7, section 4.7.6) says neonatal death is ascertained until 90 postnatal days for newborns not yet discharged. All of these wordings are kept side by side and not reconciled. The recipient is the fetus or the newborn, and the paper counts the event per patient.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Fetal or neonatal death, as the CHAP paper's Methods name it among the primary outcome events. The time window differs between the paper and the registry (see the technical summary).", "unit": "patients", "components": [] } }, { "id": "maternal:outcome-chap-medically-indicated-preterm-birth-before-35-weeks", "owner": "maternal", "slug": "outcome-chap-medically-indicated-preterm-birth-before-35-weeks", "name": "Medically indicated preterm birth before 35 weeks (CHAP definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the baby was born before 35 weeks of pregnancy because the mother or the baby was ill, and not because labor started on its own or the waters broke. It is one of the four parts of the CHAP primary combined outcome.", "summary_technical": "One of the four components of maternal:outcome-chap-primary-composite, worded as the CHAP paper's Methods words it. The paper counts the event per patient. It concerns the whole pregnancy: the birth is the baby's, and the stated reason is illness in the mother or the fetus. The paper does not say whose outcome it is, so this record assigns no single recipient. It is not the same as any preterm birth, because spontaneous labor and membrane rupture do not count.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Medically indicated preterm birth before 35 weeks' gestation, that is, a birth before 35 weeks that was done because of maternal or fetal illness and not because of spontaneous labor or membrane rupture.", "unit": "patients", "components": [] } }, { "id": "maternal:outcome-chap-placental-abruption", "owner": "maternal", "slug": "outcome-chap-placental-abruption", "name": "Placental abruption leading to delivery (CHAP definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the placenta came away from the wall of the womb before the birth and this led to the baby being delivered. CHAP also recorded other abruptions, but they did not count toward the primary combined outcome. It is one of the four parts of that outcome.", "summary_technical": "One of the four components of maternal:outcome-chap-primary-composite. The paper's Methods name it as placental abruption, without a definition, and point to the paper's Supplementary Appendix, which this atlas has not read. The protocol attached to the registry record (v1.7, section 4.7.1, page 31) narrows it: for the primary outcome it is greater than usual uterine bleeding in the absence of placenta previa or trauma, associated with contractions, non-reassuring fetal heart tones and/or a clinical diagnosis of abruption, leading to delivery. Other cases of abruption were collected but not included. Whether that protocol version is the one the paper's authors used was not checked, and the registry JSON fields themselves give no definition. The paper does not say whose outcome it is, so this record assigns no recipient.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Placental abruption as the CHAP protocol (v1.7) defines it for the primary outcome: greater than usual uterine bleeding in the absence of placenta previa or trauma, leading to delivery. Other cases of abruption were collected but did not count toward the primary outcome.", "unit": "patients", "components": [] } }, { "id": "maternal:outcome-chap-preeclampsia-with-severe-features", "owner": "maternal", "slug": "outcome-chap-preeclampsia-with-severe-features", "name": "Pre-eclampsia with severe features (CHAP definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the mother developed pre-eclampsia with severe features, up to 2 weeks after the birth. It is one of the four parts of the CHAP primary combined outcome.", "summary_technical": "One of the four components of maternal:outcome-chap-primary-composite, worded as the CHAP paper's Methods words it. Pre-eclampsia was defined by ACOG criteria. The paper adds that a blood pressure of 160/100 mm Hg or greater, with no signs or symptoms of pre-eclampsia, no proteinuria and no laboratory abnormalities, was not enough to diagnose pre-eclampsia with severe features. This outcome is narrower than maternal:outcome-chap-any-preeclampsia, which also counts pre-eclampsia without severe features. The two overlap, so they must not be added together. The recipient is the mother.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Pre-eclampsia with severe features occurring up to 2 weeks after birth, defined according to ACOG criteria.", "unit": "patients", "components": [] } }, { "id": "maternal:outcome-chap-primary-composite", "owner": "maternal", "slug": "outcome-chap-primary-composite", "name": "CHAP primary composite outcome", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "One combined measure of serious problems in the pregnancy: pre-eclampsia with severe features, a medically needed early birth before 35 weeks, the placenta separating from the womb wall before the birth and leading to delivery, or the death of the fetus or newborn. It mixes events for the mother with events for the baby, so it is not split by who has the problem.", "summary_technical": "The CHAP definition only. Other trials and guidelines combine events differently. The recipient is mixed and its findings are never split by component or summed with other outcomes. Time windows differ between sources: the manuscript counts pre-eclampsia up to 2 weeks after birth and lists fetal or neonatal death at under 28 days, while the registry gives up to 90 days for neonatal death. The paper follows patients until 6 weeks after birth, and each component has its own event window.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Any one or more of: pre-eclampsia with severe features within 2 weeks after birth; a preterm birth before 35 weeks that was medically indicated (because of illness in the mother or fetus, and not because labor began on its own or the membranes ruptured); placental abruption; death of the fetus or newborn. Pre-eclampsia was defined by ACOG criteria.", "unit": "patients", "components": [ "maternal:outcome-chap-preeclampsia-with-severe-features", "maternal:outcome-chap-medically-indicated-preterm-birth-before-35-weeks", "maternal:outcome-chap-placental-abruption", "maternal:outcome-chap-fetal-or-neonatal-death" ] } }, { "id": "maternal:outcome-chap-sga-below-10th-percentile", "owner": "maternal", "slug": "outcome-chap-sga-below-10th-percentile", "name": "Small-for-gestational-age birth weight (CHAP safety outcome)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether a baby was born smaller than expected for the length of the pregnancy. CHAP used it to check that treating the mother did not slow the baby’s growth.", "summary_technical": "CHAP primary safety outcome: a birth weight under the 10th percentile for the baby’s gestational age and sex, judged by the Duryea population standard. The recipient is the newborn; the mother received the treatment strategy. The paper counts the same denominators in two words: the Results say 128 of 1146 infants, and the Table 2 footnote says the complete-case safety analysis included 2270 patients, 1146 in the active-treatment group and 1124 in the control group. This record uses infants because the outcome is the newborn's birth weight and the Results name that unit. The trial enrolled women with a singleton fetus, so one infant corresponds to one patient.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "A birth weight in the lowest tenth for the baby’s gestational age and sex (under the 10th percentile), judged by the Duryea population standard.", "unit": "infants", "components": [] } }, { "id": "maternal:outcome-death-enrolment-to-28d", "owner": "maternal", "slug": "outcome-death-enrolment-to-28d", "name": "Infant death, enrolment to 28 days", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the baby died in its first 28 days of life.", "summary_technical": "Mortality from enrolment to 28 days of age (the neonatal period), ascertained in hospital and by a home visit on day 29.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Infant death from enrolment to 28 days of age", "unit": "infants", "components": [] } }, { "id": "maternal:outcome-death-enrolment-to-72h", "owner": "maternal", "slug": "outcome-death-enrolment-to-72h", "name": "Infant death, enrolment to 72 hours", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the baby died in its first three days of life.", "summary_technical": "Mortality from enrolment to 72 hours of age.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Infant death from enrolment to 72 hours of age", "unit": "infants", "components": [] } }, { "id": "maternal:outcome-hypothermia-ikmc", "owner": "maternal", "slug": "outcome-hypothermia-ikmc", "name": "Hypothermia (iKMC definition)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether the baby's temperature dropped too low at any point in hospital.", "summary_technical": "The trial's own definition. Other studies define hypothermia differently, so this outcome is kept separate from any general hypothermia outcome.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": null, "kind": "outcome", "payload": { "definition": "Any axillary temperature below 36 °C at any time from 2 hours after randomization until hospital discharge", "unit": "infants", "components": [] } }, { "id": "maternal:outcome-maternal-death-due-to-bleeding", "owner": "maternal", "slug": "outcome-maternal-death-due-to-bleeding", "name": "Maternal death due to bleeding", "aliases": [ "Death due to bleeding" ], "atlases": [ "maternal" ], "summary_plain": "Whether the mother died and the cause recorded was bleeding. In WOMAN this was the main cause-specific death outcome.", "summary_technical": "WOMAN assessed cause-specific mortality with death due to bleeding as \"the key secondary outcome\". Clinicians recorded the immediate cause of death, and the main cause when there was more than one. Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first (methods wording). The summary of the paper describes the composite primary endpoint as within 42 days of giving birth, a slightly different anchor; this record uses the methods wording and notes the difference.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "postpartum" ] } }, "kind": "outcome", "payload": { "definition": "Death of the woman for which the clinician recorded bleeding as the main immediate cause of death, counted from randomisation until death, discharge or 42 days, whichever came first.", "unit": "women", "components": [] } }, { "id": "maternal:outcome-neonatal-death-28d", "owner": "maternal", "slug": "outcome-neonatal-death-28d", "name": "Neonatal death, birth to 28 completed days", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Whether a baby who was born alive died in the first 28 days of life.", "summary_technical": "ACTION-I primary outcome: death of a liveborn within 28 completed days of life, counted from birth (ANZCTR timepoint: birth to 28 completed days of life). It differs from maternal:outcome-death-enrolment-to-28d, which counts from enrolment in the iKMC trial.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "outcome", "payload": { "definition": "Death of a liveborn infant within 28 completed days of life, counted from birth, as the ACTION-I trial defined it", "unit": "infants", "components": [] } }, { "id": "maternal:elecsys-sflt1-plgf", "owner": "maternal", "slug": "elecsys-sflt1-plgf", "name": "Elecsys sFlt-1 and Elecsys PlGF (Roche)", "aliases": [ "Elecsys immunoassay sFlt-1/PLGF ratio" ], "atlases": [ "maternal" ], "summary_plain": "A pair of blood tests from Roche Diagnostics, run in a laboratory, whose results are combined into the sFlt-1/PlGF ratio. In the United States the FDA cleared it in February 2025 as an aid in judging whether a woman already in hospital with high blood pressure in pregnancy will develop pre-eclampsia with severe features (the FDA term) within two weeks. In England, NICE has recommended this ratio test, among others, to help rule pre-eclampsia in or out when it is suspected. The US and English uses are described separately, and the sources read do not show that the UK labelling and the US labelling are the same.", "summary_technical": "Applicant: Roche Diagnostics, Indianapolis (FDA 510(k) record). Electrochemiluminescence immunoassays (ECLIA) on cobas e analyzers. US labelling, as cleared under 510(k) K241453 on 2025-02-07: an aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks hospitalized for a hypertensive disorder of pregnancy, to develop pre-eclampsia with severe features within two weeks from testing, used with clinical assessment and routine laboratory testing; the regulation for the prognostic device type says it is not intended for diagnosis. The PRAECIS study validated a cut-off of 38 for that use only. NICE HTG630 recommends the Elecsys immunoassay sFlt-1/PLGF ratio under its own indications for use, and its section 2 reports that the company labelling it assessed presents the test as an aid to diagnosing pre-eclampsia and to predicting it in the short term, which differs from the US labelling and which this record does not equate with it. The same HTG630 table prints a ratio of 38 for short-term prediction between week 24 and week 36 plus 6 days, a different use and gestational window from the US one.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "uses_technology", "object": "maternal:sflt1-plgf-immunoassay", "claim": null, "label": "Uses paired electrochemiluminescence immunoassays" }, { "predicate": "measures", "object": "maternal:sflt1-plgf-ratio", "claim": null, "label": "Reports the sFlt-1/PlGF ratio" }, { "predicate": "evaluated_for", "object": "maternal:preeclampsia", "claim": "maternal:claim-praecis-k241453-performance", "label": "PRAECIS cut-off of 38 for pre-eclampsia with severe features within two weeks in hospitalized women, from the US 510(k) summary; not a diagnostic use" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "product", "payload": { "subtype": "diagnostic", "model_or_formulation": "Elecsys sFlt-1 and Elecsys PlGF immunoassays (ECLIA) for cobas e immunoassay analyzers, with the sFlt-1/PlGF ratio", "version": "Elecsys sFlt-1 and Elecsys PlGF as cleared in the United States under 510(k) K241453 (decision 2025-02-07). This is the US labelling only. The labelling that NICE HTG630 assessed is not shown to be the same.", "intended_use_snapshots": [ "maternal:fda-510k-summary-k241453-2026-10-11" ] } }, { "id": "maternal:pub-action-i-nejm-2020", "owner": "maternal", "slug": "pub-action-i-nejm-2020", "name": "ACTION-I primary results, NEJM 2020", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The main report of the WHO ACTION-I trial results, published in December 2020.", "summary_technical": "WHO ACTION Trials Collaborators. N Engl J Med 2020;383(26):2514-2525. doi:10.1056/NEJMoa2022398. PMID 33095526. PMC7660991 (Author Final Manuscript, CC BY). PubMed lists comments and letters on the article but no erratum.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "doi", "value": "10.1056/NEJMoa2022398" }, { "namespace": "pmid", "value": "33095526" }, { "namespace": "pmcid", "value": "PMC7660991" } ], "relationships": [ { "predicate": "published_in", "object": "core:nejm", "claim": null, "label": "Published in" } ], "navigation": null, "kind": "publication", "payload": { "source": "maternal:action-i-nejm-2020", "publication_type": "article", "plain_interpretation": null } }, { "id": "maternal:pub-chap-nejm-2022", "owner": "maternal", "slug": "pub-chap-nejm-2022", "name": "CHAP primary results, NEJM 2022", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The main report of the CHAP trial, published in 2022, on treating mild chronic hypertension during pregnancy.", "summary_technical": "Tita AT and the Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. N Engl J Med 2022;386(19):1781-1792. doi:10.1056/NEJMoa2201295. PMID 35363951; PMC9575330. PubMed lists comment items and no erratum.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "doi", "value": "10.1056/NEJMoa2201295" }, { "namespace": "pmid", "value": "35363951" }, { "namespace": "pmcid", "value": "PMC9575330" } ], "relationships": [ { "predicate": "published_in", "object": "core:nejm", "claim": null, "label": "Published in" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "publication", "payload": { "source": "maternal:chap-nejm-2022", "publication_type": "article", "plain_interpretation": null } }, { "id": "maternal:pub-ikmc-nejm-2021", "owner": "maternal", "slug": "pub-ikmc-nejm-2021", "name": "iKMC primary results, NEJM 2021", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The main report of the WHO Immediate KMC Study results, published in May 2021.", "summary_technical": "WHO Immediate KMC Study Group. N Engl J Med 2021;384:2028-38. doi:10.1056/NEJMoa2026486. PMID 34038632. PubMed lists no erratum.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "doi", "value": "10.1056/NEJMoa2026486" }, { "namespace": "pmid", "value": "34038632" }, { "namespace": "pmcid", "value": "PMC8108485" } ], "relationships": [ { "predicate": "published_in", "object": "core:nejm", "claim": null, "label": "Published in" } ], "navigation": null, "kind": "publication", "payload": { "source": "maternal:ikmc-nejm-2021", "publication_type": "article", "plain_interpretation": null } }, { "id": "maternal:pub-nice-ng133", "owner": "maternal", "slug": "pub-nice-ng133", "name": "NICE guideline NG133: Hypertension in pregnancy (2019, updated 2023)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The NICE guideline on diagnosing and managing high blood pressure in pregnancy, first published in June 2019 and last updated in April 2023.", "summary_technical": "NICE guideline NG133, Hypertension in pregnancy: diagnosis and management. Published 25 June 2019; the page header says last updated 17 April 2023. ISBN 978-1-4731-5130-7. Recommendations marked [2019] are from the June 2019 evidence review. This atlas states NICE recommendations in its own words, with a citation and a link.", "editorial_state": "draft", "last_substantive_edit": "2026-10-13", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "nice", "value": "NG133" }, { "namespace": "isbn", "value": "978-1-4731-5130-7" } ], "relationships": [ { "predicate": "authored_by", "object": "maternal:nice", "claim": null, "label": "Issued by" } ], "navigation": { "maternal": { "life-stage": [ "preconception", "pregnancy", "postpartum" ] } }, "kind": "publication", "payload": { "source": "maternal:nice-ng133", "publication_type": "guideline", "plain_interpretation": null } }, { "id": "maternal:pub-who-2022-acs", "owner": "maternal", "slug": "pub-who-2022-acs", "name": "WHO recommendations on antenatal corticosteroids (2022)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "WHO's 2022 advice on giving steroid injections to pregnant women who are likely to give birth early.", "summary_technical": "WHO guideline, 2022. ISBN 978-92-4-005729-6 (electronic). Licensed CC BY-NC-SA 3.0 IGO. It replaces the antenatal corticosteroid advice in WHO's 2015 recommendations on interventions to improve preterm birth outcomes.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "isbn", "value": "978-92-4-005729-6" } ], "relationships": [ { "predicate": "authored_by", "object": "maternal:who", "claim": null, "label": "Issued by" }, { "predicate": "related_to", "object": "maternal:pub-action-i-nejm-2020", "claim": null, "label": "Cites the ACTION-I primary report (reference 20)" } ], "navigation": null, "kind": "publication", "payload": { "source": "maternal:who-2022-acs", "publication_type": "guideline", "plain_interpretation": null } }, { "id": "maternal:pub-who-2022-preterm-lbw", "owner": "maternal", "slug": "pub-who-2022-preterm-lbw", "name": "WHO recommendations for care of the preterm or low-birth-weight infant (2022)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "WHO's 2022 guidance on caring for babies who are born early or small.", "summary_technical": "WHO guideline, 2022. ISBN 978-92-4-005826-2 (electronic). Licensed CC BY-NC-SA 3.0 IGO.", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "isbn", "value": "978-92-4-005826-2" } ], "relationships": [ { "predicate": "authored_by", "object": "maternal:who", "claim": null, "label": "Issued by" }, { "predicate": "related_to", "object": "maternal:pub-ikmc-nejm-2021", "claim": null, "label": "Cites the iKMC primary report (reference 39)" } ], "navigation": null, "kind": "publication", "payload": { "source": "maternal:who-2022-preterm-lbw", "publication_type": "guideline", "plain_interpretation": null } }, { "id": "maternal:pub-woman-lancet-2017", "owner": "maternal", "slug": "pub-woman-lancet-2017", "name": "WOMAN primary results, Lancet 2017", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "The main report of the WOMAN trial of tranexamic acid for bleeding after birth, published in The Lancet in 2017.", "summary_technical": "WOMAN Trial Collaborators. Lancet 2017;389(10084):2105-2116. doi:10.1016/S0140-6736(17)30638-4. PMID 28456509. PMC5446563 is the open-access version of record. An erratum (Lancet 2017;389(10084):2104, PMID 28483296) corrected the tranexamic acid concentration in the procedures section, which gave \"10 mg/mL\" where \"100 mg/mL\" was meant. The corrected text is online as of 5 May 2017, and the erratum text corrects only that concentration. This atlas reads the corrected version. Funding in the abstract includes Pfizer, which makes the tranexamic acid product used in the trial.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [ { "namespace": "doi", "value": "10.1016/S0140-6736(17)30638-4" }, { "namespace": "pmid", "value": "28456509" }, { "namespace": "pmcid", "value": "PMC5446563" } ], "relationships": [ { "predicate": "published_in", "object": "core:lancet", "claim": null, "label": "Published in" } ], "navigation": { "maternal": { "life-stage": [ "postpartum" ] } }, "kind": "publication", "payload": { "source": "maternal:woman-lancet-2017", "publication_type": "article", "plain_interpretation": null } }, { "id": "maternal:reading-path-expectant-parents", "owner": "maternal", "slug": "reading-path-expectant-parents", "name": "Reading path for expectant parents", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A suggested order for reading this atlas, from before pregnancy through birth to a baby’s first months. Each step points to one page and says in plain words what that page covers. It is a reading order, not medical advice and not a care plan. It does not tell anyone what to do.", "summary_technical": "An editorial sequence of 14 steps over 13 records, ordered by life stage: preconception, pregnancy, childbirth, postpartum, newborn and infant follow-up. It links only to existing records and each step note restates what the linked record says. It branches nowhere. It is not a care pathway. Several pages cover guidance for one country (NICE for England, the FDA for the United States) or one trial population, and each page states its own scope.", "editorial_state": "draft", "last_substantive_edit": "2026-10-13", "last_evidence_check": null, "next_review_due": null, "external_ids": [], "relationships": [], "navigation": { "maternal": { "life-stage": [ "preconception", "pregnancy", "childbirth", "postpartum", "newborn", "infant-follow-up" ] } }, "kind": "reading_path", "payload": { "audience": "Expectant parents and families who want to read about pregnancy, birth and a baby’s first months in the order they happen.", "steps": [ { "entity": "maternal:chronic-hypertension-in-pregnancy", "explanation": "Before pregnancy. This is high blood pressure that a woman already has when she becomes pregnant, or that is found in the first 20 weeks. The page explains that decisions in pregnancy differ: some blood pressure medicines are not advised, and whether to treat mildly raised pressure has been debated. It also links to the CHAP trial, which looked at treating mild chronic hypertension in pregnancy." }, { "entity": "maternal:preeclampsia", "explanation": "In pregnancy. Pre-eclampsia is a condition of pregnancy in which blood pressure rises after 20 weeks and, at the same time, there are signs that other parts of the body are affected, such as protein in the urine or problems with the kidneys, liver, blood or brain. The page uses the NICE definition and says that other guidelines and trials define it differently." }, { "entity": "maternal:nulliparity", "explanation": "In pregnancy. NICE lists nulliparity as one of six moderate risk factors for pre-eclampsia and uses the term without defining it. NICE does not say how much it raises the risk on its own. Having more than one moderate factor is a reason NICE gives for advising low-dose aspirin. In August 2022 NICE changed an earlier wording, first pregnancy, to this term, so the two are not treated as the same." }, { "entity": "maternal:low-dose-aspirin-preeclampsia-prevention", "explanation": "In pregnancy. In England, NICE tells clinicians to advise a small daily dose of aspirin, 75 mg to 150 mg, from 12 weeks of pregnancy until the birth, for women at high risk of pre-eclampsia and for women with more than one moderate risk factor. NICE notes that for this use aspirin has to be prescribed, and that community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine. WHO gives different advice with its own risk lists. A recommendation is not an authorization." }, { "entity": "maternal:sflt1-plgf-ratio", "explanation": "In pregnancy. Two proteins, sFlt-1 and placental growth factor (PlGF), are measured in the same blood sample and one is divided by the other. The result is used in two different ways in two countries. In the United States, the FDA clears one version as an aid for judging, within two weeks, the risk of pre-eclampsia with severe features in women already in hospital with high blood pressure, and it is not intended for diagnosis. In England, NICE recommends named tests to help rule pre-eclampsia in or out when it is suspected between 20 weeks and 36 weeks and 6 days. The two uses are not interchangeable." }, { "entity": "maternal:antenatal-corticosteroids", "explanation": "In pregnancy, when an early birth is likely. These are steroid medicines, dexamethasone or betamethasone, given by injection to the pregnant woman. The medicine reaches the baby and helps the lungs mature, which can protect the baby’s breathing after an early birth. The mother receives the medicine and the baby is the one meant to benefit. The page covers the ACTION-I trial and the WHO 2022 recommendation, which applies only when five stated conditions are met." }, { "entity": "maternal:postpartum-hemorrhage", "explanation": "Childbirth. Postpartum haemorrhage is heavy bleeding after a baby is born. It is one of the most common complications of childbirth and a leading cause of death for mothers worldwide, and most of those deaths happen in low- and middle-income countries. The page gives two WHO figures with their own years and bases and does not combine them. It explains that bleeding is often noticed late when blood loss is judged by eye, and that WHO 2025 recommends measuring blood loss objectively. A calibrated drape is one way to measure it." }, { "entity": "maternal:tranexamic-acid-pph-treatment", "explanation": "After birth. This is a medicine given into a vein, on top of usual care, to women who are bleeding heavily after birth. In the WOMAN trial it lowered deaths from bleeding but did not clearly change deaths from all causes or hysterectomy. WHO recommends giving it early, within 3 hours of birth. The page is about treating bleeding that has started. WHO 2025 does not recommend the medicine to prevent bleeding in women who are not bleeding heavily." }, { "entity": "maternal:hypertensive-disorders-of-pregnancy", "explanation": "After birth and later in life. This page groups high blood pressure that is present before pregnancy or starts during it: chronic hypertension, gestational hypertension and pre-eclampsia. NICE puts the share of pregnant women affected by these disorders at about 8% to 10%. The page also holds one NICE statement that applies after any of them: NICE tells clinicians to advise women that a hypertensive disorder of pregnancy is linked with a higher chance of high blood pressure and cardiovascular disease later in life." }, { "entity": "maternal:preterm-lbw-care", "explanation": "The newborn period. This is the care of a baby born early or small, from birth through the first two years. It includes skin-to-skin care with a parent, feeding with the mother’s own milk, breathing support when it is needed, keeping the baby warm, and support for the family in hospital and after going home." }, { "entity": "maternal:newborn-thermal-care", "explanation": "The newborn period. Thermal care means keeping a newborn warm and preventing a low body temperature. The iKMC trial measured low body temperature as a secondary outcome, using its own definition." }, { "entity": "maternal:kangaroo-mother-care", "explanation": "The newborn period. Kangaroo mother care is holding the baby skin-to-skin on the mother’s chest for long periods, together with breastfeeding." }, { "entity": "maternal:immediate-kmc", "explanation": "The newborn period. This is starting skin-to-skin care within hours of birth, even before a small baby is fully stable, with the mother staying in the newborn unit. In the iKMC trial, babies weighing 1.0 to under 1.8 kg who started it within hours of birth were less likely to die in their first 28 days than babies who started it only after they were stable. WHO rates its recommendation to start kangaroo mother care as soon as possible after birth for babies born early or small as a strong recommendation based on high-certainty evidence." }, { "entity": "maternal:preterm-lbw-care", "explanation": "Infant follow-up. The WHO guidance behind this page covers care from birth to 24 months, including support for the family in hospital and after going home. This atlas has so far recorded only one of WHO’s 25 recommendations, immediate kangaroo mother care, so what to expect after going home is not yet covered here. Coverage is planned." } ] } }, { "id": "maternal:nulliparity", "owner": "maternal", "slug": "nulliparity", "name": "Nulliparity", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "NICE uses the term nulliparity without defining it. MeSH files it under parity, which MeSH defines as \"The number of offspring a female has borne.\" NICE lists it as one of six moderate risk factors for pre-eclampsia. Having more than one of these factors is a reason NICE gives for advising low-dose aspirin. NICE does not say how much nulliparity raises the risk by itself.", "summary_technical": "A trait of the pregnant woman. The NICE NG133 page does not define nulliparity. In August 2022 NICE changed the wording of recommendation 1.1.3 from first pregnancy to nulliparity, so the two terms must not be treated as the same. MeSH defines parity as the number of offspring a female has borne, and files nulliparity under it with no definition of its own. WHO 2021 uses a different term, primiparity, in its own moderate-risk list, and this record does not treat primiparity and nulliparity as the same.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "increases_risk_of", "object": "maternal:preeclampsia", "claim": "maternal:claim-nice-ng133-1-1-3-nulliparity-risk-factor", "label": "NICE NG133 lists it as one of six moderate risk factors for pre-eclampsia; the guideline gives no risk figure" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "risk_factor", "payload": { "factor_type": "trait", "definition": "MeSH defines parity as \"The number of offspring a female has borne.\" and lists nulliparity as a narrower concept of parity without a definition of its own. NICE gives no definition.", "contexts": [ "maternal:ctx-nice-ng133-nulliparity-moderate-risk" ] } }, { "id": "maternal:action-i-trial", "owner": "maternal", "slug": "action-i-trial", "name": "WHO ACTION-I trial", "aliases": [ "ACTION-I", "WHO ACTION-I Trial" ], "atlases": [ "maternal" ], "summary_plain": "A trial in 29 hospitals in Bangladesh, India, Kenya, Nigeria and Pakistan. Pregnant women who were likely to give birth early received either a dexamethasone steroid injection or a dummy injection, to see whether the steroid lowered newborn deaths. The trial stopped early because deaths among the babies were lower in the dexamethasone group.", "summary_technical": "Multicountry, multicentre, individually randomized, parallel-group, double-blind, placebo-controlled trial (ACTRN12617000476336; CTRI/2017/04/008326). 2852 women and their 3070 fetuses were randomized; registry targets were 6018 (ANZCTR) and 6120 (CTRI, via ICTRP). Entry: gestational age 26 weeks 0 days to 33 weeks 6 days with birth planned or expected within 48 hours. Intramuscular dexamethasone 6 mg every 12 hours for up to four doses against identical placebo. Primary outcomes: neonatal death, stillbirth or neonatal death, and possible maternal bacterial infection, tested for non-inferiority with a margin of 1.25 on the relative scale. The data safety monitoring board recommended stopping after the second interim analysis, and recruitment stopped on 21 November 2019. The registries differ on first enrolment: the ICTRP view of the CTRI record lists 2017-06-01 (read as day-month-year), the same date as ANZCTR's anticipated first enrolment, while ANZCTR's actual first enrolment is 2017-12-24 and the manuscript says women were randomized from December 2017. Sponsor: WHO. The manuscript names the Gates Foundation as primary funder with additional support from WHO departments; the PubMed abstract credits both.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "anzctr", "value": "ACTRN12617000476336" }, { "namespace": "ctri", "value": "CTRI/2017/04/008326" } ], "relationships": [ { "predicate": "investigates", "object": "maternal:antenatal-corticosteroids", "claim": null, "label": "Tests dexamethasone given to the mother before preterm birth" }, { "predicate": "investigates", "object": "maternal:preterm-birth", "claim": null, "label": "Enrolled women at risk of imminent preterm birth" }, { "predicate": "investigates", "object": "maternal:outcome-neonatal-death-28d", "claim": null, "label": "Primary outcome: neonatal death by 28 completed days" }, { "predicate": "sponsored_by", "object": "maternal:who", "claim": null, "label": "Trial sponsor (manuscript, ICTRP)" }, { "predicate": "funded_by", "object": "maternal:gates-foundation", "claim": null, "label": "Primary funder (manuscript, abstract)" }, { "predicate": "funded_by", "object": "maternal:who", "claim": null, "label": "Additional support (manuscript); credited as funder in the PubMed abstract" }, { "predicate": "results_reported_in", "object": "maternal:pub-action-i-nejm-2020", "claim": null, "label": "Primary results, NEJM 2020" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy", "newborn" ] } }, "kind": "study", "payload": { "design": "Multicountry, multicentre, individually randomized (1:1, site-stratified), parallel-group, double-blind, placebo-controlled trial of intramuscular dexamethasone against identical placebo, given to women at risk of imminent preterm birth in 29 secondary- and tertiary-level hospitals. Women were randomized from December 2017 through November 2019. The sources describe the block design differently, and this is not reconciled: the manuscript says \"balanced permuted blocks of size 10\", while the CTRI record read through ICTRP describes permuted blocks of variable size.", "drug_phase": "3", "registry_statuses": [ { "status": "Stopped early", "snapshot": "maternal:anzctr-actrn12617000476336-2026-10-11" }, { "status": "Completed", "snapshot": "maternal:ictrp-ctri-2017-04-008326-2026-10-11" } ], "start_date": { "date": "2017-12-24", "type": "actual", "snapshot": "maternal:anzctr-actrn12617000476336-2026-10-11" }, "primary_completion_date": null, "completion_date": null, "countries": [ { "code": "BD", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, { "code": "IN", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, { "code": "KE", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, { "code": "NG", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, { "code": "PK", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" } ], "care_setting": { "description": "Hospital-based care at 29 secondary- and tertiary-level hospitals across six study sites. The hospitals were chosen after a standard assessment so that the WHO conditions for antenatal corticosteroid use could reasonably be met.", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, "stopped_early": { "scope": "enrollment", "date": "2019-11-21", "reason": "After the second interim analysis the data safety monitoring board recommended stopping the trial for benefit on infant mortality, and recruitment stopped at all sites on this date. ANZCTR records the status as stopped early; the CTRI record, read through ICTRP, says completed.", "snapshot": "maternal:pmc-pmc7660991-2026-10-11" }, "enrollment": [ { "count": 2852, "basis": "randomized", "unit": "women", "snapshot": "maternal:pubmed-33095526-2026-10-11" }, { "count": 3070, "basis": "randomized", "unit": "fetuses", "snapshot": "maternal:pubmed-33095526-2026-10-11" }, { "count": 6018, "basis": "planned", "unit": "women (ANZCTR target sample size)", "snapshot": "maternal:anzctr-actrn12617000476336-2026-10-11" }, { "count": 6120, "basis": "planned", "unit": "participants (CTRI target sample size via ICTRP; the unit is not named)", "snapshot": "maternal:ictrp-ctri-2017-04-008326-2026-10-11" }, { "count": 2852, "basis": "enrolled", "unit": "participants (ANZCTR final sample size under accrual; the unit is not named)", "snapshot": "maternal:anzctr-actrn12617000476336-2026-10-11" } ], "arms": [ { "id": "maternal:action-i-trial-arm-dexamethasone", "label": "Dexamethasone (intervention)", "intervention": "maternal:antenatal-corticosteroids", "description": "Intramuscular dexamethasone 6 mg given to the woman every 12 hours, up to four doses or until hospital discharge or birth. A repeat course with the same allocation was allowed if she had not given birth after seven completed days and still met the inclusion criteria." }, { "id": "maternal:action-i-trial-arm-placebo", "label": "Identical placebo (control)", "intervention": null, "description": "Identical placebo (normal saline per ANZCTR) on the same schedule as dexamethasone, with the same repeat-course rule." } ], "findings": [ { "id": "maternal:f-action-i-neonatal-death-dexamethasone", "outcome_id": "maternal:outcome-neonatal-death-28d", "context_id": "maternal:ctx-action-i-liveborn-infants", "arm_id": "maternal:action-i-trial-arm-dexamethasone", "comparator_arm_id": null, "claim_id": "maternal:claim-action-i-neonatal-death", "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "endpoint_role": "primary", "effect_measure": "liveborn infants who died by 28 completed days of life (count)", "numeric_value": 278, "reported_text": "278/1417 (19.6)", "unit": "infants", "denominator": 1417, "denominator_status": null, "denominator_basis": "Liveborn infants in this group, as reported in Table 2 of the Author Final Manuscript; not checked against the version of record.", "time_window": "Birth to 28 completed days of life", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-action-i-neonatal-death-placebo", "outcome_id": "maternal:outcome-neonatal-death-28d", "context_id": "maternal:ctx-action-i-liveborn-infants", "arm_id": "maternal:action-i-trial-arm-placebo", "comparator_arm_id": null, "claim_id": "maternal:claim-action-i-neonatal-death", "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "endpoint_role": "primary", "effect_measure": "liveborn infants who died by 28 completed days of life (count)", "numeric_value": 331, "reported_text": "331/1406 (23.5)", "unit": "infants", "denominator": 1406, "denominator_status": null, "denominator_basis": "Liveborn infants in this group, as reported in Table 2 of the Author Final Manuscript; not checked against the version of record.", "time_window": "Birth to 28 completed days of life", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-action-i-neonatal-death-rr", "outcome_id": "maternal:outcome-neonatal-death-28d", "context_id": "maternal:ctx-action-i-liveborn-infants", "arm_id": "maternal:action-i-trial-arm-dexamethasone", "comparator_arm_id": "maternal:action-i-trial-arm-placebo", "claim_id": "maternal:claim-action-i-neonatal-death", "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "endpoint_role": "primary", "effect_measure": "relative risk, dexamethasone vs placebo, modelled with adjustment for study site and for clustering from multiple births (Table 2 footnote)", "numeric_value": 0.84, "reported_text": "0.84 (0.72-0.97)", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Birth to 28 completed days of life", "estimate_lower": 0.72, "estimate_upper": 0.97, "interval_method": "95% confidence interval, adjusted for multiplicity (Table 2 footnote)", "interval_status": null } ] } }, { "id": "maternal:chap-trial", "owner": "maternal", "slug": "chap-trial", "name": "CHAP (Chronic Hypertension and Pregnancy) trial", "aliases": [ "CHAP" ], "atlases": [ "maternal" ], "summary_plain": "A large trial in the United States that asked whether women with mildly raised blood pressure before or early in pregnancy do better if they take blood pressure medicine to keep their pressure under 140/90, or if they take medicine only when their pressure becomes severe. Everyone knew which approach they were in.", "summary_technical": "Pragmatic, open-label, randomized trial (NCT02299414; phase 4 in the registry). 2408 women were enrolled (the Results text reports 2419 randomized and 2408 analysed). Primary outcome: a composite of pre-eclampsia with severe features, medically indicated preterm birth before 35 weeks, placental abruption, or fetal or neonatal death. Primary safety outcome: a birth weight under the 10th percentile for the baby’s gestational age (small for gestational age). The funder was the National Heart, Lung, and Blood Institute; the registry names the University of Alabama at Birmingham as lead sponsor (no record in this atlas yet). The registry start date (2015-06) and the manuscript’s screening period (from September 2015) differ; the registry date is the one recorded.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "nct", "value": "NCT02299414" } ], "relationships": [ { "predicate": "investigates", "object": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "claim": null, "label": "Tests a blood-pressure goal below 140/90 mm Hg against treating only severe hypertension" }, { "predicate": "investigates", "object": "maternal:chronic-hypertension-in-pregnancy", "claim": null, "label": "Enrolled women with mild chronic hypertension" }, { "predicate": "investigates", "object": "maternal:preeclampsia", "claim": null, "label": "Pre-eclampsia is part of the primary composite and a secondary outcome" }, { "predicate": "funded_by", "object": "maternal:nhlbi", "claim": null, "label": "Funder (abstract funding statement)" }, { "predicate": "results_reported_in", "object": "maternal:pub-chap-nejm-2022", "claim": null, "label": "Primary results, NEJM 2022" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy", "newborn" ] } }, "kind": "study", "payload": { "design": "Pragmatic, multicenter, open-label, randomized controlled trial in the United States. Women were randomly assigned either to treatment aimed at keeping blood pressure under 140/90 mm Hg (the active group) or to standard care, in which blood-pressure drugs were not given, or were stopped if already in use, unless severe hypertension appeared. The sample size was reduced from a planned 4700 to a final 2404; the monitoring board for data and safety agreed to the reduction. A blinded outcome adjudication committee reviewed suspected primary and selected secondary outcomes. Follow-up ran to 6 weeks after birth.", "drug_phase": "4", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" } ], "start_date": { "date": "2015-06", "type": "actual", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" }, "primary_completion_date": { "date": "2022-04-01", "type": "actual", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" }, "completion_date": { "date": "2022-12-16", "type": "actual", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" }, "countries": [ { "code": "US", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" } ], "care_setting": { "description": "Recruiting sites of the CHAP Trial Consortium in the United States (more than 70 per the Methods; 2419 women were randomized at 61 sites per the Results). The manuscript does not say whether the sites were clinics or hospitals.", "snapshot": "maternal:pmc-pmc9575330-2026-10-11" }, "stopped_early": null, "enrollment": [ { "count": 2408, "basis": "enrolled", "unit": "women", "snapshot": "maternal:pubmed-35363951-2026-10-11" }, { "count": 2408, "basis": "enrolled", "unit": "women (registry enrollment, type ACTUAL)", "snapshot": "maternal:ctgov-nct02299414-2026-10-11" }, { "count": 2419, "basis": "randomized", "unit": "women", "snapshot": "maternal:pmc-pmc9575330-2026-10-11" }, { "count": 2404, "basis": "planned", "unit": "women (final sample size approved by the data and safety monitoring board)", "snapshot": "maternal:pmc-pmc9575330-2026-10-11" }, { "count": 4700, "basis": "planned", "unit": "women (originally planned enrollment)", "snapshot": "maternal:pmc-pmc9575330-2026-10-11" } ], "arms": [ { "id": "maternal:chap-trial-arm-active", "label": "Active treatment to a goal below 140/90 mm Hg", "intervention": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "description": "Antihypertensive drugs started or continued to reach a blood-pressure goal below 140/90 mm Hg. The first-line drugs were labetalol or extended-release nifedipine, supplied by the trial investigators." }, { "id": "maternal:chap-trial-arm-control", "label": "Standard (control) treatment", "intervention": null, "description": "No antihypertensive treatment unless severe hypertension developed (systolic 160 mm Hg or higher, or diastolic 105 mm Hg or higher). Treatment already under way was withheld or stopped at randomization." } ], "findings": [ { "id": "maternal:f-chap-primary-active", "outcome_id": "maternal:outcome-chap-primary-composite", "context_id": "maternal:ctx-chap-pregnancies-composite", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-primary-composite", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "women with a primary-outcome event (count), complete-case analysis", "numeric_value": 353, "reported_text": "353/1170 (30.2%)", "unit": "women", "denominator": 1170, "denominator_status": null, "denominator_basis": "Complete-case analysis: women with sufficient data on the primary outcome (Table 2 footnote). 1208 women were assigned to the treated group and 1200 to the control group.", "time_window": "No single period is stated for the composite. Pre-eclampsia up to 2 weeks after birth; fetal or neonatal death at under 28 days (Table 2 row label). The registry gives up to 90 days for neonatal death.", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-primary-control", "outcome_id": "maternal:outcome-chap-primary-composite", "context_id": "maternal:ctx-chap-pregnancies-composite", "arm_id": "maternal:chap-trial-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-primary-composite", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "women with a primary-outcome event (count), complete-case analysis", "numeric_value": 427, "reported_text": "427/1155 (37.0%)", "unit": "women", "denominator": 1155, "denominator_status": null, "denominator_basis": "Complete-case analysis: women with sufficient data on the primary outcome (Table 2 footnote). 1208 women were assigned to the treated group and 1200 to the control group.", "time_window": "No single period is stated for the composite. Pre-eclampsia up to 2 weeks after birth; fetal or neonatal death at under 28 days (Table 2 row label). The registry gives up to 90 days for neonatal death.", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-primary-arr", "outcome_id": "maternal:outcome-chap-primary-composite", "context_id": "maternal:ctx-chap-pregnancies-composite", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": "maternal:chap-trial-arm-control", "claim_id": "maternal:claim-chap-primary-composite", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "adjusted risk ratio, active treatment vs control (multiple imputation analysis with multivariable log-binomial regression, N = 2408; Table 2 footnote)", "numeric_value": 0.82, "reported_text": "0.82 (0.74-0.92), P<0.001", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Imputation analysis of all 2408 women analysed, not the complete-case counts above (Table 2 headings)", "time_window": "No single period is stated for the composite. Pre-eclampsia up to 2 weeks after birth; fetal or neonatal death at under 28 days (Table 2 row label). The registry gives up to 90 days for neonatal death.", "estimate_lower": 0.74, "estimate_upper": 0.92, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-chap-sga10-active", "outcome_id": "maternal:outcome-chap-sga-below-10th-percentile", "context_id": "maternal:ctx-chap-newborns-sga", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-sga-safety", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "infants with birth weight below the 10th percentile (count), complete-case analysis", "numeric_value": 128, "reported_text": "128/1146 (11.2%)", "unit": "infants", "denominator": 1146, "denominator_status": null, "denominator_basis": "Complete-case analysis: infants with sufficient birth-weight data (Table 2 footnote). 1208 women were assigned to the treated group and 1200 to the control group.", "time_window": "Birth", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-sga10-control", "outcome_id": "maternal:outcome-chap-sga-below-10th-percentile", "context_id": "maternal:ctx-chap-newborns-sga", "arm_id": "maternal:chap-trial-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-sga-safety", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "infants with birth weight below the 10th percentile (count), complete-case analysis", "numeric_value": 117, "reported_text": "117/1124 (10.4%)", "unit": "infants", "denominator": 1124, "denominator_status": null, "denominator_basis": "Complete-case analysis: infants with sufficient birth-weight data (Table 2 footnote). 1208 women were assigned to the treated group and 1200 to the control group.", "time_window": "Birth", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-sga10-arr", "outcome_id": "maternal:outcome-chap-sga-below-10th-percentile", "context_id": "maternal:ctx-chap-newborns-sga", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": "maternal:chap-trial-arm-control", "claim_id": "maternal:claim-chap-sga-safety", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "primary", "effect_measure": "adjusted risk ratio, active treatment vs control (multiple imputation analysis with multivariable log-binomial regression, N = 2408; Table 2 footnote)", "numeric_value": 1.04, "reported_text": "1.04 (0.82-1.31), P = 0.76", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Imputation analysis of all 2408 patients (Table 2, N = 2408), not the complete-case counts above (Table 2 headings)", "time_window": "Birth", "estimate_lower": 0.82, "estimate_upper": 1.31, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-chap-preeclampsia-active", "outcome_id": "maternal:outcome-chap-any-preeclampsia", "context_id": "maternal:ctx-chap-women-mild-chronic-htn-singleton-lt23w", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-any-preeclampsia", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women with any pre-eclampsia (count)", "numeric_value": 295, "reported_text": "295 (24.4%)", "unit": "women", "denominator": 1208, "denominator_status": null, "denominator_basis": "All women assigned to the treated group (Table 3 column heading, N = 1208).", "time_window": "Not stated for this outcome in the manuscript text", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-preeclampsia-control", "outcome_id": "maternal:outcome-chap-any-preeclampsia", "context_id": "maternal:ctx-chap-women-mild-chronic-htn-singleton-lt23w", "arm_id": "maternal:chap-trial-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-chap-any-preeclampsia", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women with any pre-eclampsia (count)", "numeric_value": 373, "reported_text": "373 (31.1%)", "unit": "women", "denominator": 1200, "denominator_status": null, "denominator_basis": "All women assigned to the control group (Table 3 column heading, N = 1200).", "time_window": "Not stated for this outcome in the manuscript text", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-chap-preeclampsia-rr", "outcome_id": "maternal:outcome-chap-any-preeclampsia", "context_id": "maternal:ctx-chap-women-mild-chronic-htn-singleton-lt23w", "arm_id": "maternal:chap-trial-arm-active", "comparator_arm_id": "maternal:chap-trial-arm-control", "claim_id": "maternal:claim-chap-any-preeclampsia", "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "endpoint_role": "secondary", "effect_measure": "risk ratio, active treatment vs control (Table 3 treatment effect; the table footnote says it is a risk ratio and the abstract does not call it adjusted)", "numeric_value": 0.79, "reported_text": "0.79 (0.69 to 0.89)", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Not stated for this outcome in the manuscript text", "estimate_lower": 0.69, "estimate_upper": 0.89, "interval_method": "95% confidence interval", "interval_status": null } ] } }, { "id": "maternal:ikmc-study", "owner": "maternal", "slug": "ikmc-study", "name": "WHO Immediate KMC Study (iKMC)", "aliases": [ "iKMC", "I-KMC" ], "atlases": [ "maternal" ], "summary_plain": "A trial in five hospitals in Africa and India that tested starting skin-to-skin care right after birth for small babies, compared with starting it after they stabilized.", "summary_technical": "Multicentre, open-label randomized trial (ACTRN12618001880235; CTRI/2018/08/015369). 3211 infants and their 2944 mothers were randomized, against a registry target of 4200 infants. Birth weight 1.0 to under 1.8 kg. Primary outcomes: death to 28 days and to 72 hours. Enrolment stopped early on data and safety monitoring board advice. Primary sponsor: WHO. Funder: the Bill & Melinda Gates Foundation, per the abstract and both registries; PubMed's grant field separately lists the World Health Organization with grant ID \"001\".", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "anzctr", "value": "ACTRN12618001880235" }, { "namespace": "ctri", "value": "CTRI/2018/08/015369" } ], "relationships": [ { "predicate": "investigates", "object": "maternal:immediate-kmc", "claim": null, "label": "Tests immediate KMC" }, { "predicate": "investigates", "object": "maternal:low-birth-weight", "claim": null, "label": "Enrolled infants weighing 1.0 to under 1.8 kg at birth" }, { "predicate": "sponsored_by", "object": "maternal:who", "claim": null, "label": "Primary sponsor (ANZCTR, ICTRP)" }, { "predicate": "funded_by", "object": "maternal:gates-foundation", "claim": null, "label": "Funder (abstract, ANZCTR, ICTRP)" }, { "predicate": "results_reported_in", "object": "maternal:pub-ikmc-nejm-2021", "claim": null, "label": "Primary results, NEJM 2021" } ], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "kind": "study", "payload": { "design": "Multicentre, non-blinded (open-label), parallel-group randomized trial in five tertiary hospitals. Randomization was stratified by site and birth weight (1.0 to under 1.5 kg and 1.5 to under 1.8 kg) in variable blocks; twins were allocated to the same group. An independent team assessed outcomes. Mother-infant pairs were randomized: 3211 infants with 2944 mothers. Screening ran from 30 November 2017 to 20 January 2020.", "drug_phase": "not_applicable", "registry_statuses": [ { "status": "Stopped early", "snapshot": "maternal:anzctr-actrn12618001880235-2026-10-09" }, { "status": "Completed", "snapshot": "maternal:ictrp-ctri-2018-08-015369-2026-10-09" } ], "start_date": { "date": "2017-12-01", "type": null, "snapshot": "maternal:anzctr-actrn12618001880235-2026-10-09" }, "primary_completion_date": null, "completion_date": null, "countries": [ { "code": "GH", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "IN", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "MW", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "NG", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "TZ", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" } ], "care_setting": { "description": "Five tertiary-level hospitals. The intervention arm used a Mother-NICU, a newborn intensive care unit with beds for mothers.", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, "stopped_early": { "scope": "enrollment", "date": null, "reason": "After the second interim analysis, the data and safety monitoring board recommended stopping because of reduced mortality with immediate KMC. The CTRI record, seen through the WHO ICTRP mirror, gives the status as completed.", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, "enrollment": [ { "count": 3211, "basis": "randomized", "unit": "infants", "snapshot": "maternal:pubmed-34038632-2026-10-09" }, { "count": 2944, "basis": "randomized", "unit": "mothers", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" } ], "arms": [ { "id": "maternal:ikmc-study-arm-immediate", "label": "Immediate KMC (intervention)", "intervention": "maternal:immediate-kmc", "description": "Continuous skin-to-skin contact with the mother, or a female surrogate, started as soon as possible after birth in a Mother-NICU and continued in the KMC ward. ANZCTR gives an aim of at least 20 hours a day. Median time to first skin-to-skin contact was 1.3 hours, and the median daily duration in the NICU was 16.9 hours." }, { "id": "maternal:ikmc-study-arm-control", "label": "Conventional care, then KMC after stabilization (control)", "intervention": null, "description": "Care in an incubator or radiant warmer in the NICU, without the mother, until the infant stabilized. Brief KMC sessions were allowed once the infant was recovering and at least 24 hours old. Continuous KMC followed in the KMC ward after stabilization. Median time to first skin-to-skin contact was 53.6 hours, and the median daily duration in the NICU was 1.5 hours." } ], "findings": [ { "id": "maternal:f-ikmc-28d-immediate", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 191, "reported_text": "191/1596 (12.0%)", "unit": "infants", "denominator": 1596, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1609 infants were assigned to this arm.", "time_window": "Enrolment to 28 days of age", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-28d-control", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 249, "reported_text": "249/1587 (15.7%)", "unit": "infants", "denominator": 1587, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1602 infants were assigned to this arm.", "time_window": "Enrolment to 28 days of age", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-28d-arr", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)", "numeric_value": 0.75, "reported_text": "aRR 0.75 (0.64 to 0.89), P=0.001", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Enrolment to 28 days of age", "estimate_lower": 0.64, "estimate_upper": 0.89, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-ikmc-72h-immediate", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 74, "reported_text": "74/1606 (4.6%)", "unit": "infants", "denominator": 1606, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1609 infants were assigned to this arm.", "time_window": "Enrolment to 72 hours of age", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-72h-control", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 92, "reported_text": "92/1599 (5.8%)", "unit": "infants", "denominator": 1599, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1602 infants were assigned to this arm.", "time_window": "Enrolment to 72 hours of age", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-72h-arr", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)", "numeric_value": 0.77, "reported_text": "aRR 0.77 (0.58 to 1.04), P=0.09", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Enrolment to 72 hours of age", "estimate_lower": 0.58, "estimate_upper": 1.04, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-ikmc-hypothermia-immediate", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_measure": "infants with at least one hypothermia episode (count)", "numeric_value": 90, "reported_text": "90/1609 (5.6%)", "unit": "infants", "denominator": 1609, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript. It equals the number assigned to this arm.", "time_window": "From 2 hours after randomization to hospital discharge", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-hypothermia-control", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_measure": "infants with at least one hypothermia episode (count)", "numeric_value": 133, "reported_text": "133/1602 (8.3%)", "unit": "infants", "denominator": 1602, "denominator_status": null, "denominator_basis": "As reported in Table 3 of the author accepted manuscript. It equals the number assigned to this arm.", "time_window": "From 2 hours after randomization to hospital discharge", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-hypothermia-arr", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_measure": "adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)", "numeric_value": 0.65, "reported_text": "aRR 0.65 (0.51 to 0.83)", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "From 2 hours after randomization to hospital discharge", "estimate_lower": 0.51, "estimate_upper": 0.83, "interval_method": "95% confidence interval, not adjusted for multiplicity (Table 3 footnote)", "interval_status": null } ] } }, { "id": "maternal:woman-trial", "owner": "maternal", "slug": "woman-trial", "name": "WOMAN trial (World Maternal Antifibrinolytic Trial)", "aliases": [ "WOMAN", "World Maternal Antifibrinolytic Trial", "WOrld Maternal ANtifibrinolytic Trial" ], "atlases": [ "maternal" ], "summary_plain": "A large trial that tested whether tranexamic acid, added to usual care, helps women who are bleeding heavily after giving birth. About 20 000 women in 193 hospitals in 21 countries took part. Neither the women nor the staff knew who got the medicine and who got a dummy injection (placebo).", "summary_technical": "International, randomised, double-blind, placebo-controlled trial of women aged 16 years and older with a clinical diagnosis of PPH after vaginal birth or caesarean section. Registrations ISRCTN76912190, NCT00872469 and PACTR201007000192283. Enrolled 20 060 women (ClinicalTrials.gov count; the paper prints 20 060). Analysed numbers differ by table and are never added: 10 036 and 9985 for the death-by-cause analysis (Table 2), and 10 032 and 9985 for the primary composite (Table 3). The structured enrollment list holds the enrolled count and the analysed counts of the two groups for the death-by-cause analysis (10 036 and 9985) as separate entries, never added together. The 10 032 of Table 3 is not an enrollment entry: it is the denominator of the primary composite analysis, which is a claim-only result. The primary outcome was death from any cause or hysterectomy within 42 days of randomisation; death due to bleeding was the key secondary outcome. The planned sample of 15 000 was raised to 20 000 during the trial, because hysterectomy decisions were often made at the same time as randomisation. Dates differ by source and are shown side by side: ClinicalTrials.gov gives a start of 2009-05, a primary completion of 2016-06 and a completion of 2017-04; ISRCTN gives recruitment from 2009-03-01 to 2016-05-30 and an overall end date of 2016-05-30; the paper says women were enrolled between March 2010 and April 2016. Sponsor: London School of Hygiene and Tropical Medicine (no organisation record yet). Funders named in the abstract: that school, Pfizer, the UK Department of Health, the Wellcome Trust and the Gates Foundation. Pfizer made the trial tranexamic acid. The paper names 21 countries. The structured country list holds all 21, including the Democratic Republic of Congo. The registries list different sets of countries.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [ { "namespace": "isrctn", "value": "ISRCTN76912190" }, { "namespace": "nct", "value": "NCT00872469" }, { "namespace": "pactr", "value": "PACTR201007000192283" } ], "relationships": [ { "predicate": "investigates", "object": "maternal:tranexamic-acid-pph-treatment", "claim": null, "label": "Tests tranexamic acid added to usual care" }, { "predicate": "investigates", "object": "maternal:postpartum-hemorrhage", "claim": null, "label": "Enrolled women with a clinical diagnosis of postpartum haemorrhage" }, { "predicate": "investigates", "object": "maternal:outcome-maternal-death-due-to-bleeding", "claim": null, "label": "Key secondary outcome" }, { "predicate": "investigates", "object": "core:outcome-death-any-cause", "claim": null, "label": "Reports death from any cause" }, { "predicate": "funded_by", "object": "maternal:gates-foundation", "claim": null, "label": "Funder named in the abstract" }, { "predicate": "results_reported_in", "object": "maternal:pub-woman-lancet-2017", "claim": null, "label": "Primary results, Lancet 2017" } ], "navigation": { "maternal": { "life-stage": [ "postpartum" ] } }, "kind": "study", "payload": { "design": "International, randomised, double-blind, placebo-controlled, parallel-group trial in 193 hospitals. Women were allocated by choosing a numbered treatment pack from a box of eight packs that were identical apart from the number. Participants, caregivers and outcome assessors were masked. Analysis was by intention to treat, with complete cases and no imputation.", "drug_phase": "3", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "maternal:ctgov-nct00872469-2026-10-11" } ], "start_date": { "date": "2009-05", "type": null, "snapshot": "maternal:ctgov-nct00872469-2026-10-11" }, "primary_completion_date": { "date": "2016-06", "type": "actual", "snapshot": "maternal:ctgov-nct00872469-2026-10-11" }, "completion_date": { "date": "2017-04", "type": "actual", "snapshot": "maternal:ctgov-nct00872469-2026-10-11" }, "countries": [ { "code": "NG", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "PK", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "UG", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "KE", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "CM", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "SD", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "GB", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "TZ", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "NP", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "ZM", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "AL", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "BD", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "ET", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "BF", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "JM", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "GH", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "PG", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "EG", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "CO", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "CI", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "code": "CD", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" } ], "care_setting": { "description": "Hospitals. The paper reports 193 hospitals in 21 countries.", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, "stopped_early": null, "enrollment": [ { "count": 20060, "basis": "enrolled", "unit": "women", "snapshot": "maternal:ctgov-nct00872469-2026-10-11" }, { "count": 10036, "basis": "analyzed", "unit": "women in the tranexamic acid group", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" }, { "count": 9985, "basis": "analyzed", "unit": "women in the placebo group", "snapshot": "maternal:pmc-pmc5446563-2026-10-11" } ], "arms": [ { "id": "maternal:woman-trial-arm-txa", "label": "Tranexamic acid plus usual care", "intervention": "maternal:tranexamic-acid-pph-treatment", "description": "1 g tranexamic acid by slow intravenous injection in addition to usual care. A second 1 g dose could be given if bleeding continued after 30 minutes or stopped and restarted within 24 hours of the first dose." }, { "id": "maternal:woman-trial-arm-placebo", "label": "Placebo plus usual care", "intervention": null, "description": "Matching placebo (sodium chloride 0.9%) given the same way in addition to usual care, with the same option of a second dose." } ], "findings": [ { "id": "maternal:f-woman-bleeding-txa", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-death-due-to-bleeding", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women who died of bleeding (count)", "numeric_value": 155, "reported_text": "155 [1·5%] of 10 036", "unit": "women", "denominator": 10036, "denominator_status": null, "denominator_basis": "Printed in the paper as 10 036 women analysed in the tranexamic acid group. Never add it to the placebo group figure; the paper prints no total.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-bleeding-placebo", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-placebo", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-death-due-to-bleeding", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women who died of bleeding (count)", "numeric_value": 191, "reported_text": "191 [1·9%] of 9985", "unit": "women", "denominator": 9985, "denominator_status": null, "denominator_basis": "Printed in the paper as 9985 women analysed in the placebo group. Never add it to the other group figure; the paper prints no total.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-bleeding-rr", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": "maternal:woman-trial-arm-placebo", "claim_id": "maternal:claim-woman-death-due-to-bleeding", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "risk ratio, tranexamic acid vs placebo, unadjusted (the paper also gives an adjusted ratio of 0.78, 95% CI 0.62 to 0.98)", "numeric_value": 0.81, "reported_text": "RR 0·81, 95% CI 0·65–1·00; p=0·045", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": 0.65, "estimate_upper": 1, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-woman-3h-txa", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-treated-within-3h", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-within-3h", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)", "numeric_value": 89, "reported_text": "89 [1·2%]", "unit": "women", "denominator": null, "denominator_status": null, "denominator_basis": "The paper prints no combined within-3-hours denominator. Figure 3 splits the window into up to 1 hour and over 1 to 3 hours, each with its own denominators, so this record leaves the denominator empty and never adds them.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-3h-placebo", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-treated-within-3h", "arm_id": "maternal:woman-trial-arm-placebo", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-within-3h", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)", "numeric_value": 127, "reported_text": "127 [1·7%]", "unit": "women", "denominator": null, "denominator_status": null, "denominator_basis": "The paper prints no combined within-3-hours denominator. Figure 3 splits the window into up to 1 hour and over 1 to 3 hours, each with its own denominators, so this record leaves the denominator empty and never adds them.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-3h-rr", "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding", "context_id": "maternal:ctx-woman-treated-within-3h", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": "maternal:woman-trial-arm-placebo", "claim_id": "maternal:claim-woman-within-3h", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "secondary", "effect_measure": "risk ratio, tranexamic acid vs placebo, within 3 hours of birth (pre-specified subgroup)", "numeric_value": 0.69, "reported_text": "RR 0·69, 95% CI 0·52–0·91; p=0·008", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": 0.52, "estimate_upper": 0.91, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-woman-allcause-txa", "outcome_id": "core:outcome-death-any-cause", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-all-cause-death", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "not_specified", "effect_measure": "women who died from any cause (count)", "numeric_value": 227, "reported_text": "227 [2·3%]", "unit": "women", "denominator": 10036, "denominator_status": null, "denominator_basis": "Printed in the paper as 10 036 women analysed in the tranexamic acid group. Never add it to the placebo group figure; the paper prints no total.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-allcause-placebo", "outcome_id": "core:outcome-death-any-cause", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-placebo", "comparator_arm_id": null, "claim_id": "maternal:claim-woman-all-cause-death", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "not_specified", "effect_measure": "women who died from any cause (count)", "numeric_value": 256, "reported_text": "256 [2·6%]", "unit": "women", "denominator": 9985, "denominator_status": null, "denominator_basis": "Printed in the paper as 9985 women analysed in the placebo group. Never add it to the other group figure; the paper prints no total.", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-woman-allcause-rr", "outcome_id": "core:outcome-death-any-cause", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "arm_id": "maternal:woman-trial-arm-txa", "comparator_arm_id": "maternal:woman-trial-arm-placebo", "claim_id": "maternal:claim-woman-all-cause-death", "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "endpoint_role": "not_specified", "effect_measure": "risk ratio, tranexamic acid vs placebo, unadjusted", "numeric_value": 0.88, "reported_text": "RR 0·88, 95% CI 0·74–1·05; p=0·16", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "From randomisation to death, discharge or 42 days, whichever came first", "estimate_lower": 0.74, "estimate_upper": 1.05, "interval_method": "95% confidence interval", "interval_status": null } ] } }, { "id": "maternal:calibrated-blood-collection-drape", "owner": "maternal", "slug": "calibrated-blood-collection-drape", "name": "Calibrated blood-collection drape", "aliases": [ "Calibrated drape", "Blood-collection drape" ], "atlases": [ "maternal" ], "summary_plain": "A drape used at vaginal birth that collects the blood and carries volume markings, so the amount lost can be measured instead of guessed by eye.", "summary_technical": "WHO 2025 Recommendation 21 names calibrated drapes for women having vaginal birth as one way to measure blood loss objectively. The recommendation is for the measurement, not for a drape or a product. WHO says most of the available evidence for vaginal birth comes from a calibrated drape. It also says tray and jar alternatives are not supported by evidence of diagnostic accuracy. E-MOTIVE tested the drape only as one part of a package with a treatment bundle and an implementation strategy, so no effect on health outcomes is credited to the drape alone.", "editorial_state": "draft", "last_substantive_edit": "2026-10-11", "last_evidence_check": "2026-10-11", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "addresses", "object": "maternal:bottleneck-pph-detection", "claim": null, "label": "Gives an objective blood-loss volume instead of visual estimation" }, { "predicate": "related_to", "object": "maternal:postpartum-hemorrhage", "claim": null, "label": "Used to detect postpartum haemorrhage" } ], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ] } }, "kind": "technology", "payload": { "principle": "Blood is collected in a calibrated container, so the volume is read directly. This replaces a visual estimate, which WHO calls frequently inaccurate.", "taxonomy_codes": [], "strengths": [ "Calibrated drapes have been shown to quantify blood loss more accurately than visual estimation (WHO 2025, Recommendation 21 remarks)." ], "limitations": [ "Most of the evidence is for vaginal birth; WHO says measuring blood loss at caesarean birth is also clinically important.", "WHO says current evidence does not support the diagnostic accuracy of alternatives such as blood collection trays and jars, so any device should be evidence-based.", "The 2023 WHO background says the earlier evidence for calibrated drapes used alone, compared with visual estimation alone, showed no clear effects on PPH-related health outcomes. The 2025 recommendation links measurement to a standard treatment protocol." ], "required_infrastructure": [ "A standardized treatment approach or protocol linked to the measurement (WHO 2025, Recommendation 21 remarks)." ] } }, { "id": "maternal:sflt1-plgf-immunoassay", "owner": "maternal", "slug": "sflt1-plgf-immunoassay", "name": "Paired sFlt-1 and PlGF immunoassays", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "Two blood tests run on the same sample in a laboratory machine, one for sFlt-1 and one for placental growth factor (PlGF), with the result reported as the ratio of the two. Different companies build the pair in different ways. This page describes the method, not any one company's product, and not whether any use of the result is recommended.", "summary_technical": "Quantitative immunoassays for sFlt-1 and PlGF, reported as the sFlt-1/PlGF ratio, in human serum (Elecsys) or in serum or K2-EDTA plasma (KRYPTOR). Two detection methods appear in the sources read. The Roche Elecsys pair uses electrochemiluminescence (ECLIA) on cobas e analyzers. The B·R·A·H·M·S KRYPTOR pair uses Time-Resolved Amplified Cryptate Emission (TRACE) technology. In the US, tests of this kind that are indicated as a prognostic aid are classified under 21 CFR 862.1602 as a prognostic test for development or progression of pre-eclampsia, Class II with special controls, and the regulation says such a device is \"not intended for diagnosis of any disease\". De Novo request DEN220027, for the KRYPTOR system, was granted under the same regulation number and product code (QWH). NICE HTG630 reports that the company labelling presents the Elecsys ratio test as an aid to diagnosing pre-eclampsia. Both statements are shown here and this record does not resolve them. NICE assessed named products under its own indications in HTG630.", "editorial_state": "draft", "last_substantive_edit": "2026-10-13", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "relationships": [ { "predicate": "measures", "object": "maternal:sflt1-plgf-ratio", "claim": null, "label": "Reports the sFlt-1/PlGF ratio" } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "kind": "technology", "payload": { "principle": "Paired quantitative immunoassays (the Elecsys assays employ a sandwich principle), one for sFlt-1 and one for PlGF, run on the same sample (serum for Elecsys, serum or K2-EDTA plasma for KRYPTOR) on an automated analyzer, with the ratio calculated from the two results. Detection is by electrochemiluminescence (Elecsys) or by Time-Resolved Amplified Cryptate Emission (B·R·A·H·M·S KRYPTOR).", "taxonomy_codes": [], "strengths": [ "The K241453 summary gives total assay times of 18 minutes for the Elecsys assays and 9 minutes for the B·R·A·H·M·S KRYPTOR assays." ], "limitations": [ "Roche's K241453 510(k) Summary says values from other manufacturers' assays \"may result in significantly different ratios\" and that only the Elecsys sFlt-1 and Elecsys PlGF assays should be used to calculate the Elecsys ratio. This record does not extend that statement to other ratios.", "In the US, 21 CFR 862.1602 says a prognostic test of this device type is \"not intended for diagnosis of any disease\", and its labelling must carry limiting statements, including that a result is not to be used to aid decisions about hospital discharge or pregnancy delivery. NICE HTG630 reports that the company labelling presents the Elecsys ratio test as an aid to diagnosing pre-eclampsia. The two statements differ and this record does not resolve them." ], "required_infrastructure": [ "Elecsys: cobas e immunoassay analyzers", "B·R·A·H·M·S KRYPTOR: the manufacturer's KRYPTOR analyzer" ] } } ], "claims": [ { "id": "maternal:claim-action-i-maternal-infection", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-action-i-women-26w0d-33w6d", "category": "safety", "statement": "In ACTION-I, possible maternal bacterial infection (defined as maternal fever of 38 degrees C or more, or clinically suspected or confirmed infection, for which therapeutic antibiotics were used) occurred in 68 of 1416 women (4.8%) given dexamethasone and 89 of 1412 (6.3%) given placebo (relative risk 0.76, 95% CI 0.56 to 1.03). The trial tested whether dexamethasone was not worse than placebo on this outcome, with a prespecified margin of 1.25 on the relative scale, and the result was consistent with that.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is one prespecified maternal outcome, counted during hospital admission only, in these hospitals and this population. It does not show that antenatal corticosteroids are safe in general, or in places that cannot meet the WHO conditions. The interval includes 1.00, so the data do not show a lower infection risk with dexamethasone. The same trial limits apply: hospitals chosen to meet WHO conditions, early stopping for benefit, and the Author Final Manuscript read in place of the version of record.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-33095526-2026-10-11", "locator": "Abstract, RESULTS, sentence 4 (continued)", "evidence_role": "supports", "applicability_note": "Abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Table 2, row Possible maternal bacterial infection", "evidence_role": "supports", "applicability_note": "Author Final Manuscript (CC BY); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Study outcomes, para 1", "evidence_role": "context", "applicability_note": "Definition of the outcome." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Statistical analysis, para 1", "evidence_role": "context", "applicability_note": "Non-inferiority margin." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Table 2, footnote on possible maternal bacterial infection", "evidence_role": "context", "applicability_note": "Captured during hospital admission only." } ] }, { "id": "maternal:claim-action-i-neonatal-death", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-action-i-liveborn-infants", "category": "effect", "statement": "In the ACTION-I trial, pregnant women at risk of imminent preterm birth, from 26 weeks 0 days to 33 weeks 6 days of pregnancy, received either dexamethasone or a dummy injection. Fewer of their liveborn babies died in the first 28 days of life in the dexamethasone group: 278 of 1417 (19.6%) against 331 of 1406 (23.5%) in the placebo group (relative risk 0.84, 95% CI 0.72 to 0.97). The medicine was given to the mother, and the outcome counted here is the baby's.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One placebo-controlled trial in 29 secondary- and tertiary-level hospitals in five low-resource countries. The hospitals were chosen so that the WHO conditions for steroid use could reasonably be met, so the result does not describe lower-level facilities or the community. The trial stopped early for benefit, short of its planned sample. About 90% of the infants were born before 37 weeks. The authors report that 45% of women received fewer than four doses, and name the difficulty of standardizing care across sites and the use of third-trimester ultrasound to confirm gestational age for many participants as limits. The relative risk is model-based, adjusted for site and for multiple births, with intervals adjusted for multiplicity. Figures come from the PubMed abstract and the Author Final Manuscript; the version of record was not fetched (HTTP 403) and the figures were not checked against it.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-33095526-2026-10-11", "locator": "Abstract, RESULTS, sentence 3", "evidence_role": "supports", "applicability_note": "Abstract of the primary report; the same infants and time window as this context." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Table 2, row Neonatal death", "evidence_role": "supports", "applicability_note": "Author Final Manuscript (CC BY); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Table 2, footnote", "evidence_role": "context", "applicability_note": "The relative risk is modelled and the intervals are adjusted for multiplicity." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Study outcomes, para 1", "evidence_role": "context", "applicability_note": "Defines neonatal death for this trial." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Discussion, para 1", "evidence_role": "context", "applicability_note": "The benefit was seen even though many women received fewer than four doses." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Study setting, para 1", "evidence_role": "context", "applicability_note": "Hospitals were selected so that the WHO treatment criteria could reasonably be met." } ] }, { "id": "maternal:claim-action-i-stillbirth-or-neonatal-death", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-action-i-fetuses-and-infants", "category": "effect", "statement": "In ACTION-I, 393 of 1532 fetuses and infants (25.7%) in the dexamethasone group were stillborn or died as newborns, against 444 of 1519 (29.2%) in the placebo group (relative risk 0.88, 95% CI 0.78 to 0.99). The trial defined this as one count across the fetal period after enrolment and the first 28 completed days of life, and the atlas does not split it into fetal and newborn parts.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The composite mixes fetal and newborn deaths and is shown as the trial defined it. The authors report no impact on stillbirth alone, which was a secondary outcome whose results were not corrected for multiple comparisons. The other limits of the neonatal death claim apply: hospitals chosen to meet WHO conditions, early stopping for benefit, and the Author Final Manuscript read in place of the version of record.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-33095526-2026-10-11", "locator": "Abstract, RESULTS, sentence 4", "evidence_role": "supports", "applicability_note": "Abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Table 2, row Any baby death", "evidence_role": "supports", "applicability_note": "Author Final Manuscript (CC BY); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Study outcomes, para 1", "evidence_role": "context", "applicability_note": "The trial calls this outcome any baby death." }, { "snapshot_id": "maternal:anzctr-actrn12617000476336-2026-10-11", "locator": "Outcomes, Primary outcome 2, Timepoint", "evidence_role": "context", "applicability_note": "ANZCTR definition of the composite." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Discussion, para 1", "evidence_role": "context", "applicability_note": "Stillbirth alone showed no effect." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Statistical analysis, para 3", "evidence_role": "context", "applicability_note": "Secondary outcomes are not corrected for multiple comparisons." } ] }, { "id": "maternal:claim-action-i-stopped-early", "owner": "maternal", "subject_entity_id": "maternal:action-i-trial", "context_id": "maternal:ctx-action-i-women-26w0d-33w6d", "category": "descriptive", "statement": "ACTION-I stopped recruiting women early. After the second interim analysis the data safety monitoring board recommended stopping the trial because deaths among infants were lower with dexamethasone, and recruitment stopped at all sites on 21 November 2019. The two registries disagree on the trial's status: ANZCTR records it as stopped early and the CTRI record, read through WHO ICTRP, as completed.", "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "The registry disagreement is recorded, not reconciled. The CTRI view is a WHO ICTRP mirror refreshed in November 2021, and the primary CTRI record could not be read.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-33095526-2026-10-11", "locator": "Abstract, RESULTS, sentence 2", "evidence_role": "supports", "applicability_note": "Abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Statistical analysis, para 3: board recommendation", "evidence_role": "supports", "applicability_note": "Author Final Manuscript (CC BY); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc7660991-2026-10-11", "locator": "Methods, Statistical analysis, para 3: recruitment stop", "evidence_role": "supports", "applicability_note": "Author Final Manuscript (CC BY); not checked against the version of record." }, { "snapshot_id": "maternal:anzctr-actrn12617000476336-2026-10-11", "locator": "Recruitment, Reason for early stopping", "evidence_role": "supports", "applicability_note": "ANZCTR record as last updated 2021-03-22." }, { "snapshot_id": "maternal:ictrp-ctri-2017-04-008326-2026-10-11", "locator": "Main record fields", "evidence_role": "opposes", "applicability_note": "ICTRP mirror of CTRI gives the status as completed." } ] }, { "id": "maternal:claim-chap-any-preeclampsia", "owner": "maternal", "subject_entity_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-chap-women-mild-chronic-htn-singleton-lt23w", "category": "effect", "statement": "In the CHAP trial, any pre-eclampsia (with or without severe features) occurred in 295 of 1208 women in the treated group (24.4%) and 373 of 1200 women in the control group (31.1%), a risk ratio of 0.79 (95% CI 0.69 to 0.89).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a secondary outcome, reported without adjustment for multiplicity, so the authors say it should not be used to infer definitive effects. The risk ratio is not described as adjusted in the abstract or the table. The time window for this outcome is not stated in the manuscript text (follow-up ran to 6 weeks after birth; the primary composite counted pre-eclampsia up to 2 weeks after birth). It overlaps with the severe-features part of the primary composite, so the two must not be added. Open-label design, one country.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-35363951-2026-10-11", "locator": "Abstract, RESULTS, sentence 5", "evidence_role": "supports", "applicability_note": "PubMed abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 3, row Any preeclampsia", "evidence_role": "supports", "applicability_note": "NIH author manuscript (PMC9575330); available for text mining and fair use only; not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 3, column headings and footnote", "evidence_role": "context", "applicability_note": "Group sizes and the type of treatment effect." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Methods, Statistical analysis, para 4", "evidence_role": "context", "applicability_note": "Secondary outcomes are not adjusted for multiplicity." } ] }, { "id": "maternal:claim-chap-primary-composite", "owner": "maternal", "subject_entity_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-chap-pregnancies-composite", "category": "effect", "statement": "In the CHAP trial in the United States, women with mild chronic hypertension who enrolled before 23 weeks of pregnancy and were treated to a blood-pressure goal below 140/90 mm Hg had fewer of the combined serious pregnancy problems than women whose treatment was held back unless their blood pressure became severe. The combined outcome (pre-eclampsia with severe features, a medically indicated preterm birth before 35 weeks, placental abruption, or the death of the fetus or newborn) occurred in 353 of 1170 women with outcome data in the treated group (30.2%) and 427 of 1155 in the control group (37.0%). A separate analysis that fills in missing outcomes gave an adjusted risk ratio of 0.82 (95% CI 0.74 to 0.92).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Open-label trial in one country, so women and clinicians knew the assigned strategy. The composite mixes a maternal event with pregnancy events and fetal or neonatal events; the sources do not split it by recipient and the atlas does not either. The percentages and counts come from the complete-case analysis (2325 of 2408 women had enough data); the adjusted risk ratio comes from a multiple-imputation analysis of all 2408. They are different analyses. The authors’ secondary composites of serious maternal complications and of severe neonatal complications did not show clear differences in the abstract; they are about the mother and the newborn separately, so they are not recorded here as claims of their own. Secondary results were not adjusted for multiplicity. For women with newly diagnosed hypertension and for a body-mass index of 40 or more, the risk ratios were close to 1.00 with wide intervals. About 12 women were screened for each woman randomized. The sample size was reduced from a planned 4700 women to a final 2404 that the data and safety monitoring board approved, and the abstract and the Methods word the upper blood-pressure limit differently (below 160/100 vs below 160 and below 105 mm Hg). The registry calls the primary outcome perinatal although it includes a maternal event.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-35363951-2026-10-11", "locator": "Abstract, RESULTS, sentence 2", "evidence_role": "supports", "applicability_note": "PubMed abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 2, row Primary composite outcome", "evidence_role": "supports", "applicability_note": "NIH author manuscript (PMC9575330); available for text mining and fair use only; not checked against the version of record. Counts are complete-case; the first ratio is the multiple-imputation adjusted risk ratio." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 2, column headings and footnotes", "evidence_role": "context", "applicability_note": "Shows which analysis each column comes from." }, { "snapshot_id": "maternal:pubmed-35363951-2026-10-11", "locator": "Abstract, RESULTS, sentence 4", "evidence_role": "context", "applicability_note": "Secondary composites without clear differences." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Results, Subgroup analyses", "evidence_role": "context", "applicability_note": "Subgroups close to no difference; the trial was not powered for subgroups." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Discussion, para 3", "evidence_role": "context", "applicability_note": "Open-label design and the screening ratio." } ] }, { "id": "maternal:claim-chap-sga-safety", "owner": "maternal", "subject_entity_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-chap-newborns-sga", "category": "safety", "statement": "In CHAP the mothers were treated, and the safety question was the baby’s growth. Babies born small for their gestational age (birth weight below the 10th percentile) numbered 128 of 1146 with data in the treated group (11.2%) and 117 of 1124 in the control group (10.4%). The adjusted risk ratio was 1.04 (95% CI 0.82 to 1.31). The interval includes no difference, so the trial did not show a clear change in this safety outcome.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The trial was powered to detect a relative difference of 35% or more in small-for-gestational-age birth weight, so a smaller increase cannot be ruled out. The percentages come from the 2270 patients with sufficient data (complete-case analysis of the safety outcome); the adjusted risk ratio comes from a multiple-imputation analysis of all 2408 patients (Table 2, N = 2408). Open-label design, one country. The recipient is the newborn, exposed through the mother’s treatment.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-35363951-2026-10-11", "locator": "Abstract, RESULTS, sentence 3", "evidence_role": "supports", "applicability_note": "PubMed abstract of the primary report." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 2, row Small for gestational age, <10th percentile", "evidence_role": "supports", "applicability_note": "NIH author manuscript (PMC9575330); available for text mining and fair use only; not checked against the version of record. Counts are complete-case; the first ratio is the multiple-imputation adjusted risk ratio." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Table 2, column headings and footnotes", "evidence_role": "context", "applicability_note": "Shows which analysis each column comes from." }, { "snapshot_id": "maternal:pmc-pmc9575330-2026-10-11", "locator": "Methods, Statistical analysis, para 1", "evidence_role": "context", "applicability_note": "Power of the trial for this outcome." } ] }, { "id": "maternal:claim-den220027-classification", "owner": "maternal", "subject_entity_id": "maternal:sflt1-plgf-immunoassay", "context_id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "category": "regulatory", "statement": "FDA granted De Novo request DEN220027 for the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, from Brahms GmbH, part of Thermo Fisher Scientific, on 2023-05-18. The FDA record carries product code QWH and 21 CFR 862.1602, the regulation for a prognostic test for development or progression of pre-eclampsia, which is Class II with special controls. FDA's later 510(k) summary for the Elecsys test names this KRYPTOR system as its predicate device.", "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "A De Novo grant is not a recommendation to use the test. NICE HTG630 recommendation 1.6 does not recommend the BRAHMS KRYPTOR ratio test for routine NHS use, so a US grant and an English statement of non-recommendation can both hold. No product record for the KRYPTOR system exists, so no regulatory decision record is written for it. The decision summary PDF was fetched, but its scanned text has character errors in trade names, so the facts here come from the openFDA record, the denovo.cfm page and the eCFR text. The FDA context of the Elecsys clearance is reused only because this claim concerns the same device type, although the KRYPTOR indication differs from the Elecsys one. Roche's K241453 510(k) Summary prints the KRYPTOR indication in Table 1, predicate column. It reads \"within 2 weeks of presentation\" where the Elecsys indication reads \"within two weeks from testing\", it refers to \"as defined by American College of Obstetricians and Gynecologists guidelines\" for severe features, and it accepts \"human serum and plasma (K2 EDTA)\" where the Elecsys indication names human serum. The De Novo decision summary was not used for this indication.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:openfda-510k-den220027-2026-10-11", "locator": "results[0].k_number", "evidence_role": "supports", "applicability_note": "The De Novo number as openFDA records it." }, { "snapshot_id": "maternal:openfda-510k-den220027-2026-10-11", "locator": "results[0].decision_date", "evidence_role": "supports", "applicability_note": "The decision date." }, { "snapshot_id": "maternal:openfda-510k-den220027-2026-10-11", "locator": "results[0].decision_code", "evidence_role": "supports", "applicability_note": "The decision code DENG." }, { "snapshot_id": "maternal:openfda-510k-den220027-2026-10-11", "locator": "results[0].device_name", "evidence_role": "supports", "applicability_note": "The device name as FDA records it." }, { "snapshot_id": "maternal:openfda-510k-den220027-2026-10-11", "locator": "results[0].product_code", "evidence_role": "supports", "applicability_note": "The product code." }, { "snapshot_id": "maternal:fda-denovo-page-den220027-2026-10-11", "locator": "Decision field", "evidence_role": "supports", "applicability_note": "The accessdata page states the decision as granted." }, { "snapshot_id": "maternal:fda-denovo-page-den220027-2026-10-11", "locator": "Classification fields", "evidence_role": "supports", "applicability_note": "The product code on the De Novo page." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "Section heading", "evidence_role": "supports", "applicability_note": "The regulation number and its name." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(b) Classification, sentence 1", "evidence_role": "supports", "applicability_note": "Class II with special controls." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, submitter table, predicate devices row", "evidence_role": "supports", "applicability_note": "K241453 names the KRYPTOR system, DEN220027, as its predicate." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.6, sentence 1", "evidence_role": "context", "applicability_note": "NICE does not recommend the BRAHMS ratio test for routine NHS use." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell", "evidence_role": "supports", "applicability_note": "The KRYPTOR system as printed in Roche's K241453 comparison table: automated TRACE immunofluorescent assays." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell, hospitalized population (text order without -layout)", "evidence_role": "supports", "applicability_note": "The KRYPTOR indication population: women hospitalized for hypertensive disorders of pregnancy." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, end of intended use cell (text order without -layout)", "evidence_role": "supports", "applicability_note": "The KRYPTOR time window, \"within 2 weeks of presentation\", and its reference to the American College of Obstetricians and Gynecologists definition." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell, PlGF assay sample matrix (text order without -layout)", "evidence_role": "supports", "applicability_note": "The KRYPTOR PlGF assay accepts human serum and plasma (K2 EDTA)." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Indications for Use form, second sentence, third part", "evidence_role": "context", "applicability_note": "The Elecsys wording for the outcome window, for comparison with the KRYPTOR wording." } ] }, { "id": "maternal:claim-emotive-detection", "owner": "maternal", "subject_entity_id": "maternal:pph-detection-and-first-response-bundle", "context_id": "maternal:ctx-emotive-vaginal-births-secondary-hospitals", "category": "effect", "statement": "E-MOTIVE tested a package, not a single product. The package was a calibrated blood-collection drape for early detection, a bundle of first-response treatments, and a strategy to help hospitals use them. 80 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania were randomly assigned to the package or to usual care. \"Among hospitals and patients with data\", severe bleeding (1000 mL or more), laparotomy for bleeding or death from bleeding occurred in 1.6% of patients with the package and 4.3% with usual care (risk ratio 0.40, 95% CI 0.32 to 0.50). Postpartum haemorrhage was detected in 93.1% against 51.1% (rate ratio 1.58, 1.41 to 1.76), and the bundle was used in 91.2% against 19.4% (rate ratio 4.94, 3.88 to 6.28).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The effect belongs to the whole package (drape, bundle and implementation strategy) and cannot be split by component, so none of it is credited to the drape or to tranexamic acid alone. Randomisation was by hospital. Only the NEJM abstract was read, because the full text returned HTTP 403 and was not retrieved another way, so analysis methods are not described. The percentages are results among hospitals and patients with data and are not counts of individual patients. The registry gives 99659 enrolled (actual), describes the research participants as health care providers attending vaginal births, and lists no masking; the paper reports 210,132 vaginal deliveries. These are different bases and are not reconciled. The primary outcome is a composite, so the abstract gives no separate effect on maternal death.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-37158447-2026-10-11", "locator": "Abstract, METHODS: package and cluster design", "evidence_role": "supports", "applicability_note": "PubMed abstract; the full text was not retrieved." }, { "snapshot_id": "maternal:pubmed-37158447-2026-10-11", "locator": "Abstract, RESULTS: primary outcome, detection and bundle use", "evidence_role": "supports", "applicability_note": "PubMed abstract; results among hospitals and patients with data." }, { "snapshot_id": "maternal:ctgov-nct04341662-2026-10-11", "locator": "protocolSection.designModule: enrollment count and masking", "evidence_role": "context", "applicability_note": "Registry JSON; a different basis from the paper." }, { "snapshot_id": "maternal:ctgov-nct04341662-2026-10-11", "locator": "protocolSection.descriptionModule.detailedDescription: research participants", "evidence_role": "context", "applicability_note": "Registry wording on who the participants are." } ] }, { "id": "maternal:claim-fda-k241453-indication", "owner": "maternal", "subject_entity_id": "maternal:elecsys-sflt1-plgf", "context_id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "category": "regulatory", "statement": "FDA cleared Elecsys sFlt-1 and Elecsys PlGF under 510(k) K241453 on 2025-02-07 for use as an aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks who are hospitalized for a hypertensive disorder of pregnancy (pre-eclampsia, chronic hypertension with or without superimposed pre-eclampsia, or gestational hypertension). The aid is for judging whether pre-eclampsia with severe features will develop within two weeks from testing. The ratio is to be used in conjunction with clinical assessment and routine laboratory testing. The FDA regulation for this type of device says the device is not intended for diagnosis of any disease.", "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to a predicate, here the B·R·A·H·M·S KRYPTOR system granted under De Novo request DEN220027. It is not an approval and not an FDA recommendation to use the test for any individual woman. The cleared use is narrow: hospitalized women, a singleton pregnancy, 23+0 to 34+6/7 weeks and a two-week outlook. It does not cover diagnosis. The labelling rules in the regulation say a result is not to be used to aid decisions about hospital discharge or pregnancy delivery. Do not apply this claim to the NICE use in England or to other populations. Only the indication wording and the clearance facts were read, not the full device labelling.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:openfda-510k-k241453-2026-10-11", "locator": "results[0].decision_date", "evidence_role": "supports", "applicability_note": "The decision date in the openFDA record." }, { "snapshot_id": "maternal:openfda-510k-k241453-2026-10-11", "locator": "results[0].decision_description", "evidence_role": "supports", "applicability_note": "The decision, Substantially Equivalent." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Clearance letter, page 1, paragraph 1", "evidence_role": "supports", "applicability_note": "A 510(k) premarket notification, with a finding of substantial equivalence for the stated indications." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Clearance letter, page 1, reference block", "evidence_role": "supports", "applicability_note": "Regulation, regulatory class and product code." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Indications for Use form", "evidence_role": "supports", "applicability_note": "The indication wording, split into fragments of at most 24 words. Roche's text as released by FDA; short quotation only." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, submitter table, predicate devices row", "evidence_role": "context", "applicability_note": "The predicate device named in the summary." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(a) Identification, sentence 3", "evidence_role": "supports", "applicability_note": "21 CFR 862.1602 says the device type is not intended for diagnosis of any disease." } ] }, { "id": "maternal:claim-idea-ikmc-high-resource", "owner": "maternal", "subject_entity_id": "maternal:idea-immediate-kmc-high-resource-nicu", "context_id": "maternal:ctx-newborns-1000-1799g-high-resource-nicu", "category": "hypothesis", "statement": "Hypothesis, not a result: starting continuous skin-to-skin care immediately after birth might also lower deaths or illness among infants of 1.0 to under 1.8 kg in high-resource neonatal intensive care units. The iKMC trial that found fewer deaths ran in five tertiary hospitals in Ghana, India, Malawi, Nigeria and Tanzania, and its authors say further studies in well-resourced settings could help show whether the results apply to low-mortality settings with intensive infant monitoring.", "evidence_stage": "hypothesis", "certainty": "not_assessed", "certainty_method": null, "limitations": "No test of immediate KMC in a high-resource unit is recorded in this atlas. The iKMC authors say the effect cannot be separated from the mother's continuous presence.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Discussion, para 3", "evidence_role": "context", "applicability_note": "The authors say applicability to low-mortality settings with intensive monitoring is untested." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Discussion, para 5", "evidence_role": "context", "applicability_note": "The effect of early starting cannot be separated from the mother's presence." } ] }, { "id": "maternal:claim-ikmc-28d-mortality", "owner": "maternal", "subject_entity_id": "maternal:immediate-kmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "category": "effect", "statement": "In the iKMC trial, babies weighing 1.0 to under 1.8 kg at birth who started continuous skin-to-skin care with their mother within hours of birth were less likely to die in their first 28 days than babies who started it only after they were stable. 191 of 1596 babies died in the immediate group and 249 of 1587 in the control group (adjusted risk ratio 0.75, 95% CI 0.64 to 0.89).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3). The per-arm denominators (1596 and 1587) are smaller than the numbers randomized (1609 and 1602). They come from the author manuscript's Table 3 only, its text does not state their basis, and they were not checked against the version of record.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-34038632-2026-10-09", "locator": "Abstract, RESULTS, sentence 3: \"relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001\"", "evidence_role": "supports", "applicability_note": "Abstract of the primary report, for the same infants and time window as this context." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, row \"Death between enrolment and 28 days of age\": \"191/1596 (12.0%)\" and \"249/1587 (15.7%)\"", "evidence_role": "supports", "applicability_note": "Author accepted manuscript (CC BY 4.0); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, column header: \"Adjusted RR (95%CI)\"", "evidence_role": "context", "applicability_note": "The ratios are adjusted, not crude; see the Table 3 footnote." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Discussion, para 5: \"20% of infants 1.0 to <1.8 kg born in study hospitals were not enrolled because mother or newborn was too sick\"", "evidence_role": "context", "applicability_note": "Limits who the result describes." } ] }, { "id": "maternal:claim-ikmc-72h-mortality", "owner": "maternal", "subject_entity_id": "maternal:immediate-kmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "category": "effect", "statement": "In the first 72 hours, 74 of 1606 babies died with immediate skin-to-skin care and 92 of 1599 with the control approach (adjusted risk ratio 0.77, 95% CI 0.58 to 1.04). The interval includes no difference, so the trial did not show a clear effect in this window.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3). Fewer deaths in this window make the estimate less precise. The per-arm denominators (1606 and 1599) come from the author manuscript's Table 3 only, its text does not state their basis, and they were not checked against the version of record.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-34038632-2026-10-09", "locator": "Abstract, RESULTS, sentence 3: \"relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09\"", "evidence_role": "supports", "applicability_note": "Abstract of the primary report, for the same infants and time window as this context." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, row 2 (death between enrolment and 72 hours of age): 74/1606 (4.6%) and 92/1599 (5.8%)", "evidence_role": "supports", "applicability_note": "Author accepted manuscript (CC BY 4.0); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, column header: \"Adjusted RR (95%CI)\"", "evidence_role": "context", "applicability_note": "The ratios are adjusted, not crude; see the Table 3 footnote." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Discussion, para 5: \"20% of infants 1.0 to <1.8 kg born in study hospitals were not enrolled because mother or newborn was too sick\"", "evidence_role": "context", "applicability_note": "Limits who the result describes." } ] }, { "id": "maternal:claim-ikmc-hypothermia", "owner": "maternal", "subject_entity_id": "maternal:immediate-kmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "category": "effect", "statement": "Fewer babies in the immediate skin-to-skin group had a recorded low temperature (under 36 °C at the armpit) during their hospital stay: 90 of 1609 versus 133 of 1602 (adjusted risk ratio 0.65, 95% CI 0.51 to 0.83).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Secondary outcome. Its confidence interval is not adjusted for multiplicity, and the authors say such intervals should not be used to infer definitive effects. Temperatures were measured in an open-label trial. The trial's hypothermia definition differs from other studies. One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3).", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, hypothermia row: \"90/1609 (5.6%) 133/1602 (8.3%) 0.65 (0.51–0.83)\"", "evidence_role": "supports", "applicability_note": "Author accepted manuscript (CC BY 4.0); not checked against the version of record." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, footnote 1: \"Any instance of axillary temperature <36ºC at any time from 2 hours after randomization until discharge from hospital.\"", "evidence_role": "context", "applicability_note": "The trial's own hypothermia definition." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Table 3, footnote dagger: \"The 95% confidence intervals for secondary outcomes are not adjusted for multiplicity and should not be used to infer definitive intervention effects.\"", "evidence_role": "context", "applicability_note": "The authors' own caution on this secondary outcome." } ] }, { "id": "maternal:claim-ikmc-stopped-early", "owner": "maternal", "subject_entity_id": "maternal:ikmc-study", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "category": "descriptive", "statement": "The iKMC trial stopped enrolling babies early because its data and safety monitoring board found fewer deaths with immediate skin-to-skin care.", "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "The registries disagree on the trial's status: ANZCTR records it as stopped early, while the WHO ICTRP mirror of the CTRI record gives its status as completed. The primary CTRI record could not be fetched. This is recorded, not reconciled.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pubmed-34038632-2026-10-09", "locator": "Abstract, RESULTS, last sentence: \"The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality\"", "evidence_role": "supports", "applicability_note": "Abstract of the primary report, for the same infants and time window as this context." }, { "snapshot_id": "maternal:anzctr-actrn12618001880235-2026-10-09", "locator": "Recruitment, Reason for early stopping", "evidence_role": "supports", "applicability_note": "ANZCTR record as last updated 2021-04-07." }, { "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "locator": "Methods, Statistical analysis, para 1: \"After the second interim analysis, the DSMB recommended stopping enrolment in the trial because of a clear benefit in neonatal survival.\"", "evidence_role": "supports", "applicability_note": "Author accepted manuscript (CC BY 4.0); not checked against the version of record." }, { "snapshot_id": "maternal:ictrp-ctri-2018-08-015369-2026-10-09", "locator": "Main record fields, recruitment status", "evidence_role": "opposes", "applicability_note": "WHO ICTRP mirror of CTRI, refreshed 2021-11-24; the primary register could not be fetched." } ] }, { "id": "maternal:claim-nice-htg630-1-1", "owner": "maternal", "subject_entity_id": "maternal:plgf-based-testing", "context_id": "maternal:ctx-nice-htg630-suspected-preterm-preeclampsia-20w-36w6d", "category": "recommendation", "statement": "NICE recommends four named tests that are based on placental growth factor (PLGF). They are to be used alongside the usual clinical assessment, as an aid to ruling pre-eclampsia in or out in people who are suspected of having preterm pre-eclampsia at 20 weeks to 36 weeks and 6 days of pregnancy, so that decisions about care can be made. The four tests are DELFIA Xpress PLGF 1-2-3, DELFIA Xpress sFlt-1/PLGF 1-2-3 ratio, Elecsys immunoassay sFlt-1/PLGF ratio and Triage PLGF Test. NICE adds that each test is to be used within its manufacturer's stated indications for use, and adds that some manufacturers do not indicate their tests for the whole gestational range.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "NICE recommends against using the tests to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia (recommendation 1.4), and recommends using a test once for each episode of suspected preterm pre-eclampsia (recommendation 1.5). NICE also does not recommend a fifth test, the BRAHMS sFlt-1 Kryptor/BRAHMS PLGF plus Kryptor PE ratio, for routine NHS use (recommendation 1.6). That statement is kept here and not as a separate recommendation, because no product record exists for that test. The recommendation is NICE's for the NHS and is not the US FDA-cleared use of the Elecsys test. The page gives no strength grade or certainty rating, and no performance figures are recorded here. The guidance was migrated from diagnostics guidance 49 with its content unchanged. Only the NICE pages read on 2026-10-11 were checked for a later edition.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.1, recommendation, tests and population", "evidence_role": "supports", "applicability_note": "NICE HTG630, cited and linked only. The four tests, the use with clinical assessment, the purpose and the gestational range." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.1, note on indications for use", "evidence_role": "supports", "applicability_note": "Each test is to be used according to its own indications for use." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.4", "evidence_role": "supports", "applicability_note": "A limit on use: not for decisions about a planned early birth." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.5, sentence 1", "evidence_role": "supports", "applicability_note": "A limit on use: once per episode." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.6, sentence 1", "evidence_role": "context", "applicability_note": "A fifth test that NICE does not recommend for routine NHS use." }, { "snapshot_id": "maternal:nice-htg630-overview-2026-10-11", "locator": "Overview, paragraph 3", "evidence_role": "context", "applicability_note": "Renumbering from DG49 to HTG630 with unchanged content." } ] }, { "id": "maternal:claim-nice-ng133-1-1-2-aspirin-high-risk", "owner": "maternal", "subject_entity_id": "maternal:low-dose-aspirin-preeclampsia-prevention", "context_id": "maternal:ctx-nice-ng133-pregnant-high-risk-preeclampsia", "category": "recommendation", "statement": "NICE tells clinicians to advise women who are pregnant and at high risk of pre-eclampsia to take aspirin every day at a dose of 75 mg to 150 mg, from 12 weeks of pregnancy until the baby is born. High risk means having any one of five listed factors: hypertensive disease in a previous pregnancy, chronic kidney disease, autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome, type 1 or type 2 diabetes, or chronic hypertension.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a guideline recommendation, not a marketing authorisation. The NICE page says that at publication in June 2019 aspirin had no UK marketing authorisation for this use, and that community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine, and also that aspirin for this use must be prescribed. The page gives no strength grade, no certainty rating and no effect size for this advice, so none is recorded. The dose range, the start time and the risk list are NICE's. WHO 2021 recommends 75 mg per day for women at moderate or high risk, with different risk lists, and says to start by 20 weeks or as soon as antenatal care starts (WHO labels this a \"Context-specific recommendation\"), so the advice differs between issuers. Do not apply this claim outside the NICE context.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.2, first sentence and lead-in to the list", "evidence_role": "supports", "applicability_note": "NICE NG133, cited and linked only. The dose, the start time and the end point." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.2, high-risk list and recommendation tag", "evidence_role": "supports", "applicability_note": "The five factors that define high risk, and the tag [2010, amended 2019]." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Antiplatelet agents, note before 1.1.2", "evidence_role": "context", "applicability_note": "Marketing authorisation status in the UK at June 2019, and the need for a prescription." }, { "snapshot_id": "maternal:nice-ng133-update-info-2026-10-11", "locator": "June 2019 update, changes made without an evidence review", "evidence_role": "context", "applicability_note": "NICE says it amended the aspirin dose information in June 2019 without an evidence review." }, { "snapshot_id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "locator": "Table 1, recommendation", "evidence_role": "context", "applicability_note": "WHO 2021, a different issuer with a different dose and risk lists. Shown to mark that issuers differ, not to support the NICE advice." }, { "snapshot_id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "locator": "Table 2, recommendation", "evidence_role": "context", "applicability_note": "WHO 2021 start time, which differs from the NICE start time." } ] }, { "id": "maternal:claim-nice-ng133-1-1-3-aspirin-moderate-risk", "owner": "maternal", "subject_entity_id": "maternal:low-dose-aspirin-preeclampsia-prevention", "context_id": "maternal:ctx-nice-ng133-pregnant-two-moderate-risk-factors", "category": "recommendation", "statement": "NICE tells clinicians to advise women who are pregnant and have more than one moderate risk factor for pre-eclampsia to take aspirin every day at a dose of 75 mg to 150 mg, from 12 weeks of pregnancy until the baby is born. The six moderate risk factors are nulliparity, age 40 years or older, a pregnancy interval of more than 10 years, a body mass index of 35 kg/m2 or more at the first visit, a family history of pre-eclampsia and a multi-fetal pregnancy.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a guideline recommendation, not a marketing authorisation. The NICE page says that at publication in June 2019 aspirin had no UK marketing authorisation for this use, and that community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine, and also that aspirin for this use must be prescribed. The page gives no strength grade, no certainty rating and no effect size, so none is recorded. A single moderate factor does not meet the NICE advice; the advice needs more than one. WHO 2021 recommends 75 mg per day for women at moderate or high risk and defines moderate risk as any two of its own list, which includes primiparity rather than nulliparity, so the issuers differ in dose, risk list and start time. Do not apply this claim outside the NICE context.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.3, first sentence and lead-in to the list", "evidence_role": "supports", "applicability_note": "NICE NG133, cited and linked only. The dose, the start time and the number of factors needed." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.3, moderate-risk list, items 1 to 3", "evidence_role": "supports", "applicability_note": "The first three of the six moderate risk factors, beginning with nulliparity." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.3, moderate-risk list, items 4 to 6 and recommendation tag", "evidence_role": "supports", "applicability_note": "The last three moderate risk factors, and the tag [2010, amended 2019]." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Antiplatelet agents, note before 1.1.2", "evidence_role": "context", "applicability_note": "Marketing authorisation status in the UK at June 2019, and the need for a prescription." }, { "snapshot_id": "maternal:nice-ng133-update-info-2026-10-11", "locator": "June 2019 update, changes made without an evidence review", "evidence_role": "context", "applicability_note": "NICE says it amended the aspirin dose information in June 2019 without an evidence review." }, { "snapshot_id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "locator": "Table 1, recommendation", "evidence_role": "context", "applicability_note": "WHO 2021, a different issuer with a different dose. Shown to mark that issuers differ." }, { "snapshot_id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "locator": "Table 1, remarks, bullet 2", "evidence_role": "context", "applicability_note": "WHO's moderate-risk rule: any two of a list that names primiparity." }, { "snapshot_id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "locator": "Table 2, recommendation", "evidence_role": "context", "applicability_note": "WHO 2021 start time, which differs from the NICE start time." } ] }, { "id": "maternal:claim-nice-ng133-1-1-3-nulliparity-risk-factor", "owner": "maternal", "subject_entity_id": "maternal:nulliparity", "context_id": "maternal:ctx-nice-ng133-nulliparity-moderate-risk", "category": "descriptive", "statement": "NICE lists nulliparity as one of six factors that indicate moderate risk of pre-eclampsia, alongside age 40 years or older, a pregnancy interval of more than 10 years, a body mass index of 35 kg/m2 or more at the first visit, a family history of pre-eclampsia and a multi-fetal pregnancy. NICE advises aspirin for women who have more than one of these factors.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "NICE does not say how much nulliparity raises the risk by itself, and the NICE page does not define the term, so no risk figure is recorded. In August 2022 NICE corrected the wording of recommendation 1.1.3 from first pregnancy to nulliparity, so the two terms must not be used as if they meant the same. WHO 2021 uses a different term, primiparity, in its own moderate-risk list. A list of risk factors is not an estimate of risk for any one woman.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.3, moderate-risk list, items 1 to 3", "evidence_role": "supports", "applicability_note": "NICE NG133, cited and linked only. Nulliparity is the first item of the list." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "1.1.3, moderate-risk list, items 4 to 6 and recommendation tag", "evidence_role": "supports", "applicability_note": "The other three moderate risk factors." }, { "snapshot_id": "maternal:nice-ng133-update-info-2026-10-11", "locator": "Minor changes since publication, August 2022", "evidence_role": "context", "applicability_note": "NICE's own correction of the term in recommendation 1.1.3." }, { "snapshot_id": "maternal:mesh-m0015959-2026-10-11", "locator": "scopeNote.@value, sentence 1", "evidence_role": "context", "applicability_note": "MeSH definition of parity, the term that groups nulliparity. It is not a definition of nulliparity itself." } ] }, { "id": "maternal:claim-nice-ng133-1-10-2-later-cvd", "owner": "maternal", "subject_entity_id": "maternal:hypertensive-disorders-of-pregnancy", "context_id": "maternal:ctx-nice-ng133-after-hdp-later-life", "category": "descriptive", "statement": "NICE (recommendation 1.10.2) tells clinicians to explain to women who had any type of hypertensive disorder during pregnancy that these disorders are linked with a raised chance of hypertension and cardiovascular disease as they get older. NICE’s Table 6 gives approximate sizes of the increase for each type of disorder.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is guidance that summarises other studies, not a new analysis. It covers any hypertensive disorder of pregnancy, so it must not be read as pre-eclampsia alone carrying the risk; Table 6 has separate columns for pre-eclampsia, gestational hypertension and chronic hypertension, and some cells say the risk may be increased or give no data. NICE says the figures in the table are overall estimates that condense results reported as risk, odds or hazard ratios, and that the comparison group is women who did not have a hypertensive disorder in pregnancy. Table 6 marks the later-hypertension row as not applicable for chronic hypertension. The table gives no absolute risks, since they depend on the follow-up time. The page does not state a jurisdiction; England is inferred from the issuer.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Recommendation 1.10.2, fragments 1 and 2", "evidence_role": "supports", "applicability_note": "NICE guideline NG133; cited and linked only, with no NICE wording on public pages." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Table 6, column heading", "evidence_role": "context", "applicability_note": "Chronic hypertension has its own column." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Table 6, notes", "evidence_role": "context", "applicability_note": "How to read the table." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Table 6, row Stroke, gestational hypertension column", "evidence_role": "context", "applicability_note": "Not every cell says the risk is increased." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Table 6, row Hypertension, gestational hypertension and chronic hypertension columns", "evidence_role": "context", "applicability_note": "The chronic hypertension cell is marked not applicable." } ] }, { "id": "maternal:claim-nice-ng133-1-3-9-target", "owner": "maternal", "subject_entity_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-nice-ng133-pregnant-hypertension-on-treatment", "category": "recommendation", "statement": "NICE advises that when medicines are used to treat hypertension in pregnancy, the aim is a target blood pressure of 135/85 mmHg. NICE marks this recommendation as one it reviewed in 2019. NICE’s management tables for gestational hypertension and for pre-eclampsia give the same target, 135/85 mmHg or less.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "NICE’s target of 135/85 mmHg differs from the goal used in the CHAP trial (below 140/90 mm Hg); the atlas records both and does not reconcile them. This record has not checked whether NICE considered CHAP. The update information lists the April 2023 changes to recommendations 1.3.12 and 1.4.4 only for PlGF-based testing, and does not list 1.3.9. The recommendation sits in the chronic hypertension section while its wording is general; the tables for gestational hypertension and pre-eclampsia carry the same target with the words 135/85 mmHg or less, which 1.3.9 does not use. NICE says its update did not review treatment for the three types of hypertension in pregnancy as one group. NICE gives this recommendation no strength label. The page does not state a jurisdiction; England is inferred from the issuer.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Recommendation 1.3.9", "evidence_role": "supports", "applicability_note": "NICE guideline NG133; cited and linked only, with no NICE wording on public pages." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Section 1.3, subheading above recommendations 1.3.6 to 1.3.12", "evidence_role": "context", "applicability_note": "Where the recommendation sits." }, { "snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "locator": "Table 1 (gestational hypertension, recommendation 1.4.3) and Table 2 (pre-eclampsia, recommendation 1.5.5), row Target blood pressure", "evidence_role": "supports", "applicability_note": "NICE guideline NG133; cited and linked only, with no NICE wording on public pages. The same target appears in both tables." }, { "snapshot_id": "maternal:nice-ng133-context-2026-10-11", "locator": "Context, para 3, scope exclusion", "evidence_role": "context", "applicability_note": "Scope of the NG133 update." }, { "snapshot_id": "maternal:nice-ng133-update-info-2026-10-11", "locator": "Update information, April 2023", "evidence_role": "context", "applicability_note": "The last listed change to recommendations; 1.3.9 is not named." }, { "snapshot_id": "maternal:nice-ng133-update-info-2026-10-11", "locator": "Update information, June 2019", "evidence_role": "context", "applicability_note": "The 2019 review that the [2019] marking refers to." } ] }, { "id": "maternal:claim-praecis-k241453-performance", "owner": "maternal", "subject_entity_id": "maternal:elecsys-sflt1-plgf", "context_id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "category": "descriptive", "statement": "Roche's 510(k) summary for K241453 reports the PRAECIS study, which validated a cut-off of 38 for the Elecsys sFlt-1/PlGF ratio as an aid in judging which hospitalized pregnant women with a hypertensive disorder would develop pre-eclampsia with severe features within two weeks of testing. Of 556 women, 186 developed it and 370 did not. Sensitivity was 91.40% (95% confidence interval 86.41 to 95.00) and specificity 77.30% (72.68 to 81.47). The negative predictive value was 94.70% (91.54 to 96.94) and the positive predictive value 66.93% (60.77 to 72.68). The prevalence in the study was 33.45%.", "evidence_stage": "unknown", "certainty": "not_assessed", "certainty_method": null, "limitations": "These figures are the submitter's, from one study reported in a regulatory summary. No peer-reviewed paper on PRAECIS was read. The predictive values depend on the 33.45% prevalence of pre-eclampsia with severe features in this hospitalized population and would differ in other populations. In the table, 84 women above the cut-off did not develop pre-eclampsia with severe features within two weeks, and 16 women at or below it did. The summary says the performance criteria for negative and positive predictive value were met. The summary does not state the criteria, the study design, the sites or the dates, or how the outcome was judged. The cut-off of 38 here belongs to the US prognostic use only. The table values were checked against the page image of the PDF.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, 5 Clinical performance evaluation, paragraph 1", "evidence_role": "supports", "applicability_note": "What PRAECIS validated, as Roche's summary states it." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, 5 Clinical performance evaluation, paragraph 2", "evidence_role": "context", "applicability_note": "The study population: women aged 18 or older at 23+0 to 34+6/7 weeks who were admitted with, or developed in hospital, a hypertensive disorder of pregnancy." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, 5 Clinical performance evaluation, paragraph 3", "evidence_role": "supports", "applicability_note": "The summary's statement that the predictive-value criteria were met." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Table 15, count cells (PDF p. 25, summary p. 21)", "evidence_role": "supports", "applicability_note": "Counts above and at or below the cut-off, by outcome." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Table 15, sensitivity, specificity and NPV cells", "evidence_role": "supports", "applicability_note": "Values with 95% confidence intervals. Text order as extracted by pdftotext without -layout; the cell layout was confirmed on the page image." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Table 15, PPV, accuracy, LR- and LR+ cells", "evidence_role": "supports", "applicability_note": "The first value and interval of this block is the positive predictive value. Accuracy and likelihood ratios are in the same cells and are not used here." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Table 15, prevalence cell", "evidence_role": "supports", "applicability_note": "Prevalence (%) of pre-eclampsia with severe features in the study population." } ] }, { "id": "maternal:claim-sflt1-plgf-ratio-nice-rule-in-out-use", "owner": "maternal", "subject_entity_id": "maternal:sflt1-plgf-ratio", "context_id": "maternal:ctx-nice-htg630-suspected-preterm-preeclampsia-20w-36w6d", "category": "descriptive", "statement": "In NICE HealthTech guidance HTG630, two named ratio tests (DELFIA Xpress sFlt-1/PLGF 1-2-3 ratio and Elecsys immunoassay sFlt-1/PLGF ratio), together with two tests that measure PlGF alone, are recommended to help rule pre-eclampsia in or out in people in whom preterm pre-eclampsia is suspected between 20 weeks and 36 weeks and 6 days of pregnancy. NICE says a third ratio test, the BRAHMS sFlt-1 Kryptor/BRAHMS PLGF plus Kryptor PE ratio, is not one that NICE recommends for routine NHS use (recommendation 1.6). Section 2 of the guidance describes the company labelling of the Elecsys ratio test that NICE assessed. The labelling presents the test as an aid, alongside other clinical information, to diagnosing pre-eclampsia and to predicting it in the short term. NICE says each test is to be used within its manufacturer's stated indications for use, and recommends against using them to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is the NICE use for the NHS only. It differs from the US FDA-cleared use, where the regulation for the prognostic device type says it is not intended for diagnosis. HTG630 section 2 prints company cut-offs by intended use and stage of pregnancy, including 38 or less to rule out pre-eclampsia for one week between week 24 and week 36 plus 6 days. That number must not be read as the US cut-off of 38, which has a different outcome, window and population. No cut-off is recorded here as a rule, because NICE recommends using each test according to its indications for use. NICE gives no strength grade here. This claim does not say the tests perform well, and it records no performance figures.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "2.7, sentence 1", "evidence_role": "supports", "applicability_note": "NICE HTG630 section 2, cited and linked only. How the Elecsys ratio is formed." }, { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "2.7, sentence 2", "evidence_role": "supports", "applicability_note": "The company labelling intended use, as described by NICE: to help diagnose pre-eclampsia." }, { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "2.7, sentence 3", "evidence_role": "supports", "applicability_note": "The company labelling intended use, as described by NICE: short-term prediction." }, { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "Table 2, Elecsys cut-offs, short-term prediction rows", "evidence_role": "context", "applicability_note": "A company cut-off for one use and window. Shown to prevent it being merged with the US cut-off." }, { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "2.4, sentence 4", "evidence_role": "context", "applicability_note": "How NICE describes suspected pre-eclampsia." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.1, list of tests", "evidence_role": "supports", "applicability_note": "The two recommended ratio tests are the DELFIA Xpress and Elecsys tests; two other recommended tests measure PLGF alone." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.1, note on manufacturers' indications", "evidence_role": "supports", "applicability_note": "Some manufacturers do not indicate their tests for the whole gestational range." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.1, note on indications for use", "evidence_role": "supports", "applicability_note": "Each test is to be used according to its indications for use." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.4", "evidence_role": "supports", "applicability_note": "Not for decisions about a planned early birth." }, { "snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "locator": "1.6, sentence 1", "evidence_role": "context", "applicability_note": "NICE does not recommend the BRAHMS Kryptor ratio test for routine NHS use." } ] }, { "id": "maternal:claim-sflt1-plgf-ratio-us-prognostic-use", "owner": "maternal", "subject_entity_id": "maternal:sflt1-plgf-ratio", "context_id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "category": "descriptive", "statement": "Under 21 CFR 862.1602, FDA classifies a prognostic test for development or progression of pre-eclampsia as \"an in vitro diagnostic device\" indicated as an aid in the risk assessment for the development or progression of pre-eclampsia, and the regulation says \"This device is not intended for diagnosis of any disease.\" The Elecsys sFlt-1 and PlGF system (K241453) is cleared under this regulation, and the KRYPTOR system (DEN220027) is described in its own claim. The labelling of the Elecsys sFlt-1 and PlGF test, cleared as K241453, applies the ratio to hospitalized women with a singleton pregnancy at 23+0 to 34+6/7 weeks and a hypertensive disorder of pregnancy, to judge whether pre-eclampsia with severe features will develop within two weeks from testing, with clinical assessment and routine laboratory testing. The regulation requires labelling to say a result is not to be used to aid the diagnosis of pre-eclampsia, or decisions about hospital discharge or pregnancy delivery. The cut-off of 38 that Roche's study validated belongs to this use.", "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is the US use only. The use NICE recommends in England, to help rule pre-eclampsia in or out when it is suspected between 20 weeks and 36 weeks and 6 days, is a separate claim in a separate context. Both documents print a ratio of 38, for different stated uses, outcomes and gestational windows, so no threshold may be carried from one context to the other. Performance figures are in their own claim and come from the submitter's study. This claim describes what the documents say. It does not say which use is clinically better.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(a) Identification, sentence 1, second part", "evidence_role": "supports", "applicability_note": "21 CFR 862.1602: the device type is an in vitro diagnostic device." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(a) Identification, sentence 2", "evidence_role": "supports", "applicability_note": "21 CFR 862.1602: the device type is an aid in the risk assessment for the development or progression of pre-eclampsia." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(a) Identification, sentence 3", "evidence_role": "supports", "applicability_note": "21 CFR 862.1602: not intended for diagnosis of any disease." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(b)(2)(ii) Limiting statements, lead-in", "evidence_role": "context", "applicability_note": "The labelling of a device of this type must carry limiting statements." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(b)(2)(ii)(B)", "evidence_role": "supports", "applicability_note": "Limiting statement on diagnosis." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(b)(2)(ii)(C)", "evidence_role": "supports", "applicability_note": "Limiting statement on hospital discharge." }, { "snapshot_id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "locator": "(b)(2)(ii)(D)", "evidence_role": "supports", "applicability_note": "Limiting statement on pregnancy delivery." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Clearance letter, page 1, reference block", "evidence_role": "supports", "applicability_note": "K241453 carries regulation 21 CFR 862.1602 and product code QWH." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "Indications for Use form", "evidence_role": "supports", "applicability_note": "The K241453 indication wording, in fragments. Roche's text as released by FDA; short quotation only." }, { "snapshot_id": "maternal:fda-510k-summary-k241453-2026-10-11", "locator": "510(k) Summary, 5 Clinical performance evaluation, paragraph 1", "evidence_role": "supports", "applicability_note": "PRAECIS validated the cut-off of 38 for this use." }, { "snapshot_id": "maternal:nice-htg630-tests-2026-10-11", "locator": "Table 2, Elecsys cut-offs, short-term prediction rows", "evidence_role": "context", "applicability_note": "A 38 also appears in the NICE table, for a different use and window. Shown to prevent the two being merged." } ] }, { "id": "maternal:claim-who-2020-nonsevere-htn", "owner": "maternal", "subject_entity_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-who-2020-nonsevere-htn-pregnancy", "category": "recommendation", "statement": "WHO recommends offering antihypertensive drug treatment to women with non-severe hypertension during pregnancy, as part of good quality antenatal care follow-up. WHO labels it a context-specific recommendation. WHO’s recommendation table gives no numeric blood-pressure target.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "Published in 2020, before the CHAP report (2022), so it did not consider CHAP. WHO’s justification says drug treatment probably reduces severe hypertension but may make little or no difference to proteinuria or pre-eclampsia; this is not a GRADE rating of the recommendation, so certainty is not assessed here. WHO also says available evidence suggests calcium channel blockers should be avoided, and its evidence summary lists nifedipine among the calcium channel blockers used in the included trials, while CHAP used extended-release nifedipine as a first-line drug; the atlas records the difference and does not reconcile it. The treatment applies only with regular outpatient monitoring and review.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "locator": "Table 1, PDF p. 10 (repeated on p. 21), Recommendation 1 with its label", "evidence_role": "supports", "applicability_note": "WHO 2020 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "locator": "Table 1, PDF p. 10, Justification, bullet 1", "evidence_role": "context", "applicability_note": "WHO 2020 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "locator": "Table 1, PDF p. 10, Remarks, bullet 1", "evidence_role": "context", "applicability_note": "WHO 2020 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "locator": "Table 1, PDF p. 11, Remarks, bullet 2", "evidence_role": "context", "applicability_note": "WHO 2020 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "locator": "Evidence summary, drug list, PDF p. 34 (printed p. 26), under Calcium channel blockers", "evidence_role": "context", "applicability_note": "WHO 2020 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2022-acs-1-0", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-women-24w0d-34w0d", "category": "recommendation", "statement": "WHO recommends antenatal corticosteroid therapy for women with a high likelihood of preterm birth from 24 weeks to 34 weeks of gestation, but only when five conditions are met: gestational age can be assessed accurately, preterm birth is highly likely within 7 days of starting treatment, there is no clinical evidence of maternal infection, adequate childbirth care is available (including capacity to recognize and safely manage preterm labour and birth), and the preterm newborn can receive adequate care, including resuscitation, kangaroo mother care, thermal care, feeding support, infection treatment and respiratory support including continuous positive airway pressure (CPAP) as needed. WHO introduces that list with the word including, so the items are examples of adequate newborn care and the list is not complete. WHO's Remarks add that antenatal corticosteroids should not be routinely given where ultrasound for gestational age assessment cannot be performed. WHO classes this as a context-specific recommendation, from its 2022 update that replaced its 2015 advice. The woman is treated and the newborn is the intended beneficiary.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "WHO's four recommendation categories are not GRADE strong or conditional labels. WHO rates certainty for each outcome with GRADE and gives no single certainty rating for a recommendation, so certainty is not assessed here. The Remarks say harm cannot be excluded where the conditions cannot be met, such as lower-level health facilities and the community level. The guideline group chose 34 weeks 0 days as the upper limit because of uncertainty in the balance of benefit and harm at later gestational ages. WHO says the recommendations may be updated when new evidence appears. On 2026-10-11 title searches of WHO IRIS found no later WHO antenatal corticosteroid guideline; that is a search result, not proof of absence.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, PDF p. 19", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, conditions, PDF p. 19", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Table 1, PDF p. 10 (printed p. viii), category column", "evidence_role": "supports", "applicability_note": "The category WHO assigns." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, Remarks, upper limit", "evidence_role": "context", "applicability_note": "Why 34 weeks 0 days is the upper limit." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, Remarks, ultrasound for gestational age, PDF p. 19", "evidence_role": "context", "applicability_note": "Not to be given routinely where ultrasound dating cannot be done." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, Remarks, harms", "evidence_role": "context", "applicability_note": "Harm cannot be excluded where the conditions are not met." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "6. Updating the recommendations, PDF p. 30", "evidence_role": "context", "applicability_note": "The guideline may be updated." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "2.8.2 Assessment of certainty of the effectiveness evidence, PDF p. 16", "evidence_role": "context", "applicability_note": "WHO rates certainty for each outcome, not for each recommendation." }, { "snapshot_id": "maternal:who-pub-9789240057296-2026-10-11", "locator": "Overview, para 1", "evidence_role": "context", "applicability_note": "The 2022 recommendations replace the 2015 advice." } ] }, { "id": "maternal:claim-who-2022-acs-1-1", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-women-24w0d-34w0d", "category": "recommendation", "statement": "WHO advises giving antenatal corticosteroids to women who are highly likely to give birth preterm within the next 7 days, even if the full course may not be finished before the baby is born. WHO classes this as a context-specific recommendation, and its Remarks say the five conditions of Recommendation 1.0 still apply.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "The Remarks warn against giving the treatment just in case to women who do not have a high likelihood of preterm birth. WHO's categories are not GRADE strong or conditional labels, and WHO gives no single certainty rating for a recommendation. This claim has no separate decision record in this atlas.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.1, PDF p. 20", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Table 1, PDF p. 10 (printed p. viii), category column", "evidence_role": "supports", "applicability_note": "The category WHO assigns." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.1, Remarks, PDF p. 20", "evidence_role": "context", "applicability_note": "No treatment just in case." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.1, Remarks, last bullet, PDF p. 20", "evidence_role": "context", "applicability_note": "The Remarks say the pre-conditions of Recommendation 1.0 apply." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.0, Remarks, PDF p. 19", "evidence_role": "context", "applicability_note": "Recommendation 1.0 applies to all the others." } ] }, { "id": "maternal:claim-who-2022-acs-1-4-chorioamnionitis", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-chorioamnionitis", "category": "recommendation", "statement": "WHO recommends against antenatal corticosteroid therapy for women who have chorioamnionitis and are likely to give birth preterm. Chorioamnionitis is inflammation of the membranes around the fetus (the chorion and amnion) and connected tissues, often associated with infection rising into the womb during pregnancy (MeSH definition). WHO's Remarks say timely birth should be the priority, that treatment should not be started at the expense of timely birth when the maternal or fetal condition calls for it, and that the guideline group acknowledged a concern about the risk of exacerbating maternal infection, particularly in low- and middle-income settings where the baseline risk of maternal infectious illness is higher. The group felt this potential risk may outweigh the known benefits of the steroid in the majority of populations where steroid use is essential for improving newborn survival.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a narrow exception. It must be read next to Recommendation 1.0, which recommends the treatment when the conditions are met, including no clinical evidence of maternal infection. It does not mean antenatal corticosteroids are not recommended for preterm birth in general. WHO's categories are not GRADE strong or conditional labels, and WHO gives no single certainty rating for a recommendation, so certainty is not assessed here. The definition of chorioamnionitis comes from MeSH, not from the WHO guideline.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, PDF p. 22", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Table 1, PDF p. 10 (printed p. viii), category column", "evidence_role": "supports", "applicability_note": "The category WHO assigns." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, timely birth", "evidence_role": "context", "applicability_note": "Timely birth is the priority." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, not at the expense of birth", "evidence_role": "context", "applicability_note": "Treatment should not delay needed birth." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, ongoing systemic infection", "evidence_role": "context", "applicability_note": "Also avoid with ongoing systemic infection." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, risk of exacerbating maternal infection", "evidence_role": "context", "applicability_note": "The guideline group acknowledged a concern about the risk of exacerbating maternal infection." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, risk may outweigh benefits", "evidence_role": "context", "applicability_note": "The group felt the potential risk may outweigh the known benefits, in most populations where the steroid is essential." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, low- and middle-income settings, PDF p. 22", "evidence_role": "context", "applicability_note": "The concern is singled out for low- and middle-income settings." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.4, Remarks, majority of populations, PDF p. 22", "evidence_role": "context", "applicability_note": "The weighing applies to the majority of populations where steroid use is essential for newborn survival." }, { "snapshot_id": "maternal:mesh-m0004338-2026-10-12", "locator": "Concept M0004338, scopeNote", "evidence_role": "context", "applicability_note": "Plain definition of chorioamnionitis; MeSH, not WHO." } ] }, { "id": "maternal:claim-who-2022-acs-1-5-planned-caesarean", "owner": "maternal", "subject_entity_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-planned-caesarean-34w0d-36w6d", "category": "recommendation", "statement": "WHO recommends against antenatal corticosteroid therapy for women undergoing a planned caesarean section at 34 weeks 0 days to 36 weeks 6 days of pregnancy. WHO's Remarks describe the evidence on the balance of benefits and harms for this group as scarce, and say there might be some benefits but also harms. The guideline group considered this a research priority and chose to recommend against the practice until further evidence becomes available.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a narrow exception tied to planned caesarean birth in the late preterm period. It does not mean antenatal corticosteroids are not recommended for preterm birth in general. WHO's categories are not GRADE strong or conditional labels, and the web annex evidence tables were not fetched.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.5, PDF p. 22", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Table 1, PDF p. 10 (printed p. viii), category column", "evidence_role": "supports", "applicability_note": "The category WHO assigns." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.5, Remarks, research priority", "evidence_role": "context", "applicability_note": "Why WHO recommends against for now." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.5, Remarks, evidence", "evidence_role": "context", "applicability_note": "Evidence on the balance of benefits and harms is scarce." }, { "snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "locator": "Recommendation 1.5, Remarks, benefits and harms, PDF p. 22", "evidence_role": "context", "applicability_note": "There might be some benefits and also harms." } ] }, { "id": "maternal:claim-who-2023-burden", "owner": "maternal", "subject_entity_id": "maternal:postpartum-hemorrhage", "context_id": "maternal:ctx-global-maternal-deaths-2020", "category": "burden", "statement": "WHO's 2023 recommendations say there were an estimated 287 000 maternal deaths worldwide in 2020, most of them in the world's least developed countries. WHO says obstetric haemorrhage is the leading cause of maternal mortality, accounting for 27% of all maternal deaths occurring worldwide each year, and that most of these deaths are due to postpartum haemorrhage. WHO estimates that about 14 million women experience PPH each year.", "evidence_stage": "synthesis", "certainty": "not_assessed", "certainty_method": null, "limitations": "These are WHO estimates in an executive summary, not counts. The 27% is a share for obstetric haemorrhage as a whole, and the passage dates only the 287 000 figure to 2020. The 2025 WHO statement that PPH accounts for nearly one fifth of all maternal deaths has a different basis and is a separate claim. The two figures are not combined or reconciled. The sources WHO cites were not read.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240085398-pdf-2026-10-11", "locator": "Executive summary, Introduction, para 1", "evidence_role": "supports", "applicability_note": "WHO 2023 recommendations, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2023-visual-estimation-inaccurate", "owner": "maternal", "subject_entity_id": "maternal:bottleneck-pph-detection", "context_id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "category": "descriptive", "statement": "WHO says that visual estimation of blood loss after birth is frequently inaccurate, so postpartum haemorrhage often goes unrecognised or is identified too late to give a life-saving treatment. Objective methods of measuring blood loss are superior to visual estimation and more likely to detect PPH. The same remark is in WHO's 2023 recommendations and, unchanged, in the 2025 consolidated guideline under Recommendation 21.", "evidence_stage": "synthesis", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is an expert remark attached to a recommendation, not a measured accuracy figure. The WHO text cites a reference for calibrated drapes that this record did not read. WHO also says life-saving interventions may be used inconsistently or deployed late because of delayed diagnosis.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 21, Remarks, bullet 1: visual estimation frequently inaccurate", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240085398-pdf-2026-10-11", "locator": "Table 1, Remarks, Assessment of postpartum blood loss: the same remark in 2023", "evidence_role": "supports", "applicability_note": "WHO 2023 recommendations, CC BY-NC-SA 3.0 IGO." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Executive summary, Introduction, para 2: delayed diagnosis and late use of interventions", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2025-burden", "owner": "maternal", "subject_entity_id": "maternal:postpartum-hemorrhage", "context_id": "maternal:ctx-global-maternal-deaths-who-2025", "category": "burden", "statement": "WHO's 2025 consolidated guideline says postpartum haemorrhage accounts for nearly one fifth of all maternal deaths worldwide and is the main cause of maternal death in most low-income countries. It says about 80% of related deaths occur in low- and middle-income countries, particularly in sub-Saharan Africa and South Asia.", "evidence_stage": "synthesis", "certainty": "not_assessed", "certainty_method": null, "limitations": "The 2025 text gives no year for these figures and cites a reference that was not read. The 2023 WHO figure (obstetric haemorrhage as 27% of maternal deaths) has a different basis and is a separate claim. The two are not combined or reconciled.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Executive summary, Introduction, para 1: nearly one fifth of maternal deaths", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Introduction, para 4: about 80% of related deaths in low- and middle-income countries", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2025-pph-14-15-txa-prevention", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-who-2025-pph-prevention-at-birth", "category": "recommendation", "statement": "This claim is about prevention, a different use from the treatment that this page describes. The 2025 WHO consolidated guideline does not recommend tranexamic acid to prevent postpartum haemorrhage, either at vaginal birth (Recommendation 14) or at caesarean birth (Recommendation 15). Both are new and fall in the category Not recommended. WHO gives its own reasons for each. For Recommendation 14, the medicine showed no clinical benefit over standard preventive measures in reducing PPH, and a modest increase in clot-related events could not be confidently ruled out. For Recommendation 15, it found no additional benefit in reducing blood loss. WHO saw no clear increase in life-threatening adverse events, but said a small but clinically important increase in clot-related (thromboembolic) risk could not be ruled out, which is particularly relevant during caesarean birth when the baseline risk of clots is higher. Tranexamic acid stays recommended for treating PPH (Recommendations 27 and 29). For certain high-risk women at caesarean birth, WHO says clinicians could consider it to control bleeding even before the diagnostic criteria are met.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "Claim only, with no relationship and no decision row. The only intervention record in this atlas is the treatment record, and a decision against would sit beside a recommendation for the same record. A separate prevention intervention could carry both Not recommended recommendations as decisions. WHO says the recommendations apply at the population level to all such births and depend on the capacity to accurately assess blood loss. The evidence for these two recommendations (Web Annex A) was not read. WOMAN studied women who were already bleeding and is not evidence for this claim. WHO 2025 labels each recommendation with one of four categories and a development status. These are not GRADE strength labels, so the claim certainty is left not assessed.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 14: text, category and justification (vaginal birth)", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 15: text, category and justification (caesarean birth)", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 14, Remarks: treatment stays recommended; population-level scope", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 15, Remarks, bullet 3: clinical judgement for high-risk women", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2025-pph-21-objective-measurement", "owner": "maternal", "subject_entity_id": "maternal:objective-blood-loss-measurement", "context_id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "category": "recommendation", "statement": "WHO 2025 recommends routine objective measurement of blood loss after birth for all women giving birth, to improve the detection and prompt treatment of postpartum haemorrhage (Recommendation 21, category Recommended, Revalidated from the 2023 recommendation). WHO names calibrated drapes for women having vaginal birth as one method. The recommendation is for measuring blood loss, not for a particular product. WHO adds that measurement works only when it is linked with a standardized treatment approach.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "Most of the available evidence is from vaginal birth; WHO says measurement at caesarean birth is also clinically important. WHO says current evidence does not support the diagnostic accuracy of alternatives such as blood collection trays and jars. The evidence tables (Web Annex A, Section 4.1) were not read. The wording is identical to Recommendation 1 of the 2023 document, which WHO integrated unchanged. WHO 2025 labels each recommendation with one of four categories and a development status. These are not GRADE strength labels, so the claim certainty is left not assessed.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 21: recommendation text and category", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 21, Remarks: objective methods, drape evidence, link to treatment protocol, alternatives", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Summary list of recommendations, footnote to Recommendation 21: integrated from the 2023 recommendations", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240085398-pdf-2026-10-11", "locator": "Table 1, Recommendation 1: the same wording in 2023", "evidence_role": "context", "applicability_note": "WHO 2023 recommendations, CC BY-NC-SA 3.0 IGO; history only." } ] }, { "id": "maternal:claim-who-2025-pph-22-diagnostic-criteria", "owner": "maternal", "subject_entity_id": "maternal:objective-blood-loss-measurement", "context_id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "category": "recommendation", "statement": "WHO 2025 recommends these criteria to identify women at risk of adverse outcomes from bleeding after birth and to start first-response treatment (Recommendation 22, new, category Recommended). Objectively measured blood loss of 300 mL or more together with any abnormal sign (pulse above 100 beats a minute, shock index above 1, systolic blood pressure below 100 mmHg, or diastolic blood pressure below 60 mmHg), or objectively measured blood loss of 500 mL or more, whichever occurs first within 24 hours after birth, with particular vigilance during the first 2 hours. WHO calls this a \"therapeutic definition\", a threshold meant to guide when to start treatment rather than to classify the condition.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "WHO describes the supporting evidence as moderate-certainty, from an individual-participant meta-analysis of over 300 000 women in 12 datasets across 23 countries, with some limitations for caesarean section. The certainty here stays not assessed because the GRADE profile for this exact statement was not read. The evidence annex was not read. The definition differs from the WOMAN eligibility wording and from the older rule of thumb of more than 500 mL. WHO 2025 labels each recommendation with one of four categories and a development status. These are not GRADE strength labels, so the claim certainty is left not assessed.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 22: criteria text and category", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 22, Remarks, bullet 1: therapeutic definition", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 22, Justification: evidence base and caesarean limitation", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." } ] }, { "id": "maternal:claim-who-2025-pph-27-txa", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-who-2025-pph-women-with-pph", "category": "recommendation", "statement": "WHO, FIGO and ICM recommend, in the 2025 consolidated guideline (Recommendation 27), giving tranexamic acid into a vein early, within 3 hours of birth, in addition to standard care, for women with postpartum haemorrhage after vaginal birth or caesarean section. The category is Recommended. WHO remarks give 1 g (100 mg/mL) at 1 mL per minute, with a second 1 g dose if bleeding continues after 30 minutes or restarts within 24 hours. The 3 hours are counted from the time of birth, intravenous use only, and the medicine should be avoided with a clear contraindication. This is a treatment recommendation. WHO 2025 does not recommend the medicine for prevention (separate claim).", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "WHO labels this recommendation Edited, meaning an existing recommendation with no new impactful evidence, edited for clarity. The 2017 WHO wording said clinically diagnosed and carried the label strong recommendation, moderate quality of evidence; the 2025 text aligns diagnosis with the objective criteria of Recommendations 21 and 22, so its population is not identical to WOMAN clinically diagnosed women. WHO 2025 labels each recommendation with one of four categories and a development status. These are not GRADE strength labels, so the claim certainty is left not assessed. The guideline is co-published with FIGO and ICM; WHO is recorded as issuer because no organisation records exist yet for the other two. WHO web annexes with the evidence base were not read. Supersession was checked only by one IRIS keyword search on 2026-10-11, which listed no later WHO PPH guideline among the newest items it returned. This is not a thorough search.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 27: recommendation text and category", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 27, Remarks, bullet 1: dose and second dose", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 27, Remarks, bullets 2 to 4: diagnosis alignment, 3-hour window from birth, no use after 3 hours", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 27, Remarks, bullets 7 and 8: contraindication and intravenous use only", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Summary list of recommendations, footnote to Recommendation 27: integrated from the 2017 recommendation", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789241550154-pdf-2026-10-11", "locator": "Table 1: the 2017 wording and its strength label", "evidence_role": "context", "applicability_note": "WHO 2017 recommendation, CC BY-NC-SA 3.0 IGO; history only." } ] }, { "id": "maternal:claim-who-2025-pph-29-bundle", "owner": "maternal", "subject_entity_id": "maternal:pph-detection-and-first-response-bundle", "context_id": "maternal:ctx-who-2025-pph-vaginal-birth", "category": "recommendation", "statement": "WHO 2025 recommends a standardized and timely approach to managing postpartum haemorrhage for all women having a vaginal birth (Recommendation 29, category Recommended, Revalidated from the 2023 recommendation). The approach combines an objective assessment of blood loss with a treatment bundle supported by an implementation strategy. The first-line bundle includes rapid uterine massage, an oxytocic medicine and tranexamic acid, intravenous fluids, examination of the genital tract and escalation of care.", "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "The supporting evidence is largely from vaginal births in secondary-level facilities; WHO says more research is needed before recommending bundle care at caesarean birth, although each treatment is separately recommended. The trial behind this recommendation included multiple implementation and health system strengthening strategies, so the recommended package is more than the drape and the medicines. WHO says its evidence on measuring blood loss comes largely from trials using calibrated drapes. WHO 2025 labels each recommendation with one of four categories and a development status. These are not GRADE strength labels, so the claim certainty is left not assessed.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 29: recommendation text and category", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 29, Remarks: implementation strategies, drape evidence, caesarean research need", "evidence_role": "supports", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Summary list of recommendations, footnote to Recommendation 29: integrated from the 2023 recommendations", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240085398-pdf-2026-10-11", "locator": "Table 1, Recommendation 2: the same recommendation in 2023", "evidence_role": "context", "applicability_note": "WHO 2023 recommendations, CC BY-NC-SA 3.0 IGO; history only." } ] }, { "id": "maternal:claim-who-a1b-immediate-kmc", "owner": "maternal", "subject_entity_id": "maternal:immediate-kmc", "context_id": "maternal:ctx-who-preterm-or-lbw-infants", "category": "recommendation", "statement": "WHO recommends starting kangaroo mother care as soon as possible after birth for babies who are born early or small (preterm or low-birth-weight infants). WHO rates this a strong recommendation based on high-certainty evidence.", "evidence_stage": "guidance", "certainty": "high", "certainty_method": "GRADE, as stated by WHO in the 2022 guideline for recommendation A.1b", "limitations": "The population, all preterm or low-birth-weight infants, is broader than any single trial. In facilities, the remarks exclude infants who cannot breathe spontaneously after resuscitation, are in shock or need mechanical ventilation. The PDF prints the strength parenthetical twice in succession. The GRADE evidence tables are in a web supplement that was not fetched.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "locator": "Recommendation A.1b, PDF p. 25 (printed p. 12): \"Kangaroo mother care (KMC) for preterm or low-birth-weight infants should be started as soon as possible after birth.\"", "evidence_role": "supports", "applicability_note": "WHO 2022 guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "locator": "Recommendation A.1b, PDF p. 25, printed twice in succession: \"(Strong recommendation, high-certainty evidence)\"", "evidence_role": "supports", "applicability_note": "The strength and certainty as WHO states them." }, { "snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "locator": "A.1 Remarks, Immediate KMC, PDF p. 25: \"immediate KMC can be initiated before the infant is clinically stable\"", "evidence_role": "context", "applicability_note": "Applies in facilities." }, { "snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "locator": "A.1 Remarks, Immediate KMC, PDF p. 25: \"unless the infant is unable to breathe spontaneously after resuscitation, is in shock or needs mechanical ventilation\"", "evidence_role": "context", "applicability_note": "Facility exceptions." }, { "snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "locator": "Chapter 2, Box 2.1, PDF p. 22 (printed p. 9): \"A “strong recommendation” if the intervention is applicable to all preterm or low-birth-weight infants\"", "evidence_role": "context", "applicability_note": "Defines WHO's strength labels for this guideline." } ] }, { "id": "maternal:claim-woman-all-cause-death", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "category": "effect", "statement": "In WOMAN, 227 women given tranexamic acid (2.3%) and 256 given placebo (2.6%) died from any cause, a risk ratio of 0.88 (95% CI 0.74 to 1.05, p=0.16). The difference was not statistically significant. The authors note that more than a quarter of deaths were not due to bleeding, which dilutes any effect on all-cause death, and that the effect on death due to bleeding is the more generalisable measure.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "All-cause death was assessed separately from the primary composite and is not named as a secondary outcome in the methods, so its endpoint role is not specified. The mix of bleeding and non-bleeding deaths varies by region and hospital, so the authors say the all-cause effect is not generalisable. Denominators are 10 036 and 9985 as printed, and the paper prints no total. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Maternal death, para 1: all-cause death 227 and 256, risk ratio 0.88", "evidence_role": "supports", "applicability_note": "Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Discussion, para 2: why all-cause death is diluted", "evidence_role": "context", "applicability_note": "The authors own reading of the result." }, { "snapshot_id": "maternal:pmc-pmc6891225-2026-10-11", "locator": "Erratum text: tranexamic acid concentration corrected in the procedures section", "evidence_role": "context", "applicability_note": "The correction changes a drug concentration, not a result." } ] }, { "id": "maternal:claim-woman-composite-primary", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "category": "effect", "statement": "The primary outcome of WOMAN was death from any cause or hysterectomy within 42 days, counted in the methods from randomisation. Tranexamic acid did not clearly reduce it. 534 women in the tranexamic acid group and 546 in the placebo group had the outcome, a risk ratio of 0.97 (95% CI 0.87 to 1.09, p=0.65). Hysterectomy alone was also not reduced (358 with tranexamic acid and 351 with placebo, risk ratio 1.02, 95% CI 0.88 to 1.07 as printed, p=0.84). The fewer deaths from bleeding seen in this trial did not show up in this combined outcome.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The composite joins death with hysterectomy. The authors expected hysterectomy decisions made at the time of randomisation to dilute any effect on hysterectomy. No composite outcome record exists in this atlas, so no finding rows are entered, and this composite is never placed on the all-cause death outcome. The printed placebo percentage differs between the abstract (5.5%) and the results text (5.6%) and is not used. The hysterectomy interval is printed identically in the abstract and the results text as 0.88 to 1.07 around a ratio of 1.02, which is not symmetric; it is recorded as printed and was not recomputed, and the table itself was not located. The denominators printed for the composite are 10 032 (tranexamic acid, Table 3) and 9985 (placebo). Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Primary endpoint, para 1: 534 and 546, risk ratio 0.97", "evidence_role": "supports", "applicability_note": "Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017." }, { "snapshot_id": "maternal:pubmed-28456509-2026-10-11", "locator": "Abstract, Findings, sentence 5: composite primary endpoint not reduced", "evidence_role": "supports", "applicability_note": "PubMed abstract; the placebo percentage differs from the results text." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Hysterectomy, para 1: 358 and 351, risk ratio 1.02", "evidence_role": "supports", "applicability_note": "Interval recorded as printed." }, { "snapshot_id": "maternal:pubmed-28456509-2026-10-11", "locator": "Abstract, Findings, sentence 4: hysterectomy not reduced", "evidence_role": "supports", "applicability_note": "The same interval is printed in the abstract." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Methods, Outcomes, para 1: primary outcome definition", "evidence_role": "context", "applicability_note": "Defines the composite and its 42-day window." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Table 3, row All patients: denominators 10 032 and 9985", "evidence_role": "context", "applicability_note": "Denominators as printed; never summed." }, { "snapshot_id": "maternal:pmc-pmc6891225-2026-10-11", "locator": "Erratum text: tranexamic acid concentration corrected in the procedures section", "evidence_role": "context", "applicability_note": "The correction changes a drug concentration, not a result." } ] }, { "id": "maternal:claim-woman-death-due-to-bleeding", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-woman-women-16plus-clinical-pph", "category": "effect", "statement": "In the WOMAN trial, women with heavy bleeding after birth who were given tranexamic acid were less likely to die of bleeding than women given a placebo. 155 of 10 036 women (1.5%) died of bleeding with tranexamic acid, against 191 of 9985 (1.9%) with placebo. The risk ratio was 0.81 (95% confidence interval 0.65 to 1.00, p=0.045). The authors named death due to bleeding as the key secondary outcome. The upper end of the interval touches 1.00, and the primary outcome, death from any cause or hysterectomy, did not differ clearly between the groups (separate claim).", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Death due to bleeding is a cause-specific secondary outcome. The primary composite showed no clear difference. The upper confidence bound is 1.00. The planned sample of 15 000 was raised to 20 000 during the trial to estimate this effect, after hysterectomy decisions were found to be often made at the time of randomisation. The authors state that they pre-specified this outcome and the time-to-treatment subgroups before un-blinding. Clinicians recorded the immediate cause of death, the main cause if there were several. The trial was double-blind. The paper also gives an adjusted risk ratio of 0.78 (95% CI 0.62 to 0.98). Adverse events, including thromboembolic events, did not differ significantly between groups in WOMAN. Pfizer is among the funders and made the trial drug. Analysed numbers are those printed for this analysis (10 036 and 9985); some randomised women were excluded from analysis and the paper prints no total. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.", "editorial_state": "draft", "checked_at": "2026-10-11", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Maternal death, para 1: bleeding deaths 155 and 191, risk ratio 0.81", "evidence_role": "supports", "applicability_note": "Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017." }, { "snapshot_id": "maternal:pubmed-28456509-2026-10-11", "locator": "Abstract, Findings, sentence 2: death due to bleeding significantly reduced", "evidence_role": "supports", "applicability_note": "PubMed abstract of the same report." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Methods, Outcomes, para 1: death due to bleeding as the key secondary outcome", "evidence_role": "supports", "applicability_note": "Establishes the outcome role." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Methods, Statistical analysis, para 1: sample size increase and pre-specification before un-blinding", "evidence_role": "context", "applicability_note": "Explains why this outcome was added and when." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Summary, Findings: adverse events did not differ significantly", "evidence_role": "context", "applicability_note": "Safety context from the same trial." }, { "snapshot_id": "maternal:pmc-pmc6891225-2026-10-11", "locator": "Erratum text: tranexamic acid concentration corrected in the procedures section", "evidence_role": "context", "applicability_note": "The correction changes a drug concentration, not a result." } ] }, { "id": "maternal:claim-woman-within-3h", "owner": "maternal", "subject_entity_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-woman-treated-within-3h", "category": "effect", "statement": "Among women in WOMAN who were given tranexamic acid within 3 hours of giving birth, 89 died of bleeding against 127 given placebo, a risk ratio of 0.69 (95% CI 0.52 to 0.91, p=0.008). When treatment came after 3 hours the counts were 66 and 63, a risk ratio of 1.07 (95% CI 0.76 to 1.51, p=0.70). This is a pre-specified subgroup analysis of the secondary outcome, not the primary result. The trial stated its own rule. Unless the test for different effects across subgroups gave p below 0.001, the overall relative risk (0.81 for death due to bleeding) was regarded as the most reliable guide to subgroup effects. Figure 3 of the paper gives p=0.085 for the test of different effects across the three time-from-delivery groups (up to 1 hour, over 1 to 3 hours, over 3 hours). That is above the trial bar of 0.001, so by the trial rule the overall relative risk of 0.81 stays the better guide. Because earlier trauma data gave strong reason to expect a time effect, the authors also planned to read the timing result alongside all available data on that effect.", "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The p=0.085 in Figure 3 tests three time groups together, not the within-3-hours split alone, and the paper text gives no heterogeneity result for time to treatment on this outcome. Figure 5 of the paper sets WOMAN beside CRASH-2 results and has its own heterogeneity p value; this record did not read it. Figure 3 prints separate denominators for the up to 1 hour and over 1 to 3 hours groups and no combined within-3-hours denominator. WHO 2025 Recommendation 27 remarks rest the 3-hour window on WOMAN timing analysis and on a pooled individual-participant analysis of 40 138 bleeding patients, which includes WOMAN participants and trauma patients. Death due to bleeding is a cause-specific secondary outcome and the primary composite was not clearly reduced. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Maternal death, para 3: 89 and 127 within 3 hours; 66 and 63 after 3 hours", "evidence_role": "supports", "applicability_note": "Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017." }, { "snapshot_id": "maternal:pubmed-28456509-2026-10-11", "locator": "Abstract, Findings, sentence 2: especially within 3 hours of giving birth", "evidence_role": "supports", "applicability_note": "PubMed abstract of the same report." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Methods, Statistical analysis, para 3: homogeneity rule and overall relative risk", "evidence_role": "context", "applicability_note": "The trial own rule for reading subgroups." }, { "snapshot_id": "maternal:pmc-pmc5446563-fig3-2026-10-12", "locator": "Figure 3 image, Time from delivery (h) block: group counts and the heterogeneity p value", "evidence_role": "supports", "applicability_note": "Figure image on the PMC figure page of the open-access version of record (CC BY-NC-ND 4.0), read by eye; the numbers are not in the XML." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Results, Maternal death, Figure 3 caption: the asterisk marks the heterogeneity p value", "evidence_role": "context", "applicability_note": "Caption of the figure that holds the time-to-treatment test." }, { "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11", "locator": "Methods, Statistical analysis, para 1: subgroup pre-specified before un-blinding", "evidence_role": "context", "applicability_note": "Timing of the pre-specification." }, { "snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "locator": "Recommendation 27, Remarks, bullet 4: timing evidence behind the 3-hour window", "evidence_role": "context", "applicability_note": "WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution." }, { "snapshot_id": "maternal:pmc-pmc6891225-2026-10-11", "locator": "Erratum text: tranexamic acid concentration corrected in the procedures section", "evidence_role": "context", "applicability_note": "The correction changes a drug concentration, not a result." } ] } ], "contexts": [ { "id": "maternal:ctx-action-i-fetuses-and-infants", "label": "All fetuses of randomized women and the infants born of them, to 28 completed days of life (ACTION-I)", "recipient": "mixed", "population": "Every fetus of a randomized woman and the infants born of them, fetal and newborn together, because the trial defined stillbirth or neonatal death as one composite. The 26 weeks 0 days to 33 weeks 6 days window is the mother's gestational age at entry. Use this context only for that composite.", "care_setting": "Hospital-based: 29 secondary- and tertiary-level hospitals across six study sites. The hospitals were chosen after a standard assessment so that the WHO conditions for antenatal corticosteroid use could reasonably be met.", "geography": "Bangladesh, India, Kenya, Nigeria and Pakistan", "life_stage": "Fetal period after enrolment and neonatal period, to 28 completed days of life", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "From randomization to 28 completed days of life.", "eligibility": { "inclusion": [ "Fetus of a woman randomized in ACTION-I, and the liveborn infant it became" ], "exclusion": [] } }, { "id": "maternal:ctx-action-i-liveborn-infants", "label": "Liveborn infants of women randomized at 26w0d to 33w6d, followed to 28 completed days of life (ACTION-I)", "recipient": "newborn", "population": "Liveborn infants of the randomized women. The window of 26 weeks 0 days to 33 weeks 6 days is the mother's gestational age when she entered the trial. It does not limit the infant's gestational age at birth, and the research gives no such limit. Birth occurred before 37 weeks for 90.0% of infants in the dexamethasone group and 90.8% of infants in the placebo group.", "care_setting": "Hospital-based: 29 secondary- and tertiary-level hospitals across six study sites. The hospitals were chosen after a standard assessment so that the WHO conditions for antenatal corticosteroid use could reasonably be met.", "geography": "Bangladesh, India, Kenya, Nigeria and Pakistan", "life_stage": "Neonatal period, birth to 28 days", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": 0, "postnatal_age_max_days": 0, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Infants entered the analysis at birth and were followed until 28 days after birth or death, whichever came first. Neonatal death means death of a liveborn within 28 completed days of life. The postnatal age bounds give age at entry, not the length of follow-up.", "eligibility": { "inclusion": [ "Liveborn infant of a woman randomized in ACTION-I" ], "exclusion": [] } }, { "id": "maternal:ctx-action-i-women-26w0d-33w6d", "label": "Pregnant women at risk of imminent preterm birth at 26w0d to 33w6d, in 29 hospitals in five low-resource countries (ACTION-I)", "recipient": "maternal", "population": "Pregnant women with a confirmed live fetus, single or multiple pregnancy, who were at risk of preterm birth between 26 weeks 0 days and 33 weeks 6 days of gestation and whose birth was planned or expected within 48 hours. Gestational age came from the earliest ultrasound or one done at admission.", "care_setting": "Hospital-based: 29 secondary- and tertiary-level hospitals across six study sites. The hospitals were chosen after a standard assessment so that the WHO conditions for antenatal corticosteroid use could reasonably be met.", "geography": "Bangladesh, India, Kenya, Nigeria and Pakistan", "life_stage": "Pregnancy, from randomization to birth, with maternal infection followed to 28 days after birth", "gestational_age_min_days": 182, "gestational_age_max_days": 237, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "The maternal primary outcome, possible maternal bacterial infection, ran from randomization to 28 days postpartum and was captured during hospital admission only.", "eligibility": { "inclusion": [ "Live fetus, single or multiple pregnancy", "Gestational age 26 weeks 0 days to 33 weeks 6 days", "Birth planned or expected in the next 48 hours", "Written informed consent before randomization" ], "exclusion": [ "Clinical signs of severe infection", "Major congenital fetal anomalies", "Systemic glucocorticoid use now or within the past two weeks", "Participation in another trial", "Contraindication to steroids", "Clinical suspicion or evidence of chorioamnionitis (registry criteria only; the paper lists clinical signs of severe infection)", "No earlier ultrasound estimate of gestational age and an immediate ultrasound not possible (registry criteria only; both ANZCTR and CTRI via ICTRP list it, and the paper says gestational age came from the earliest ultrasound or one done at admission)" ] } }, { "id": "maternal:ctx-chap-newborns-sga", "label": "Infants of women enrolled in CHAP, assessed at birth for small-for-gestational-age birth weight, United States", "recipient": "newborn", "population": "Infants born to the women in the trial who had birth-weight data: 1146 in the treated group and 1124 in the control group in the complete-case analysis. The infants were exposed through their mothers’ treatment; they were not treated themselves. The women enrolled before 23 weeks, and the gestational age at birth was not restricted by the source.", "care_setting": "Births at CHAP sites in the United States; the manuscript does not describe the birth setting.", "geography": "United States", "life_stage": "Newborn, birth weight measured at birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": 0, "postnatal_age_max_days": 0, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Birth weight at birth. Only the complete-case analysis has a count of infants; the adjusted analysis imputes missing values.", "eligibility": { "inclusion": [ "Infants of women enrolled in CHAP before 23 weeks of gestation who have birth-weight data (the manuscript does not say whether stillbirths are included)" ], "exclusion": [ "Infants of women without birth-weight data are missing from the complete-case counts" ] } }, { "id": "maternal:ctx-chap-pregnancies-composite", "label": "Pregnancies of women with mild chronic hypertension and their fetuses and newborns, United States (CHAP primary composite)", "recipient": "mixed", "population": "The same women as the maternal CHAP context, with the outcomes of their pregnancies. The primary composite combines a maternal event (pre-eclampsia with severe features up to 2 weeks after birth), pregnancy events (medically indicated preterm birth before 35 weeks and placental abruption) and a fetal or neonatal event (fetal or neonatal death). It is used only for the composite as the trial defined it and is never split by recipient.", "care_setting": "Recruiting sites of the CHAP Trial Consortium in the United States; see the maternal CHAP context.", "geography": "United States", "life_stage": "Pregnancy and the newborn period", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Pre-eclampsia counted up to 2 weeks after birth. Fetal or neonatal death is listed at under 28 days in the manuscript table; the registry gives up to 90 days for neonatal death.", "eligibility": { "inclusion": [ "The same enrolment criteria as the maternal CHAP context" ], "exclusion": [ "The same exclusions as the maternal CHAP context" ] } }, { "id": "maternal:ctx-chap-women-mild-chronic-htn-singleton-lt23w", "label": "Pregnant women with mild chronic hypertension and a singleton pregnancy before 23 weeks, United States (CHAP trial)", "recipient": "maternal", "population": "Pregnant women with known or new chronic hypertension and a viable singleton fetus before 23 weeks of gestation. Mild means below the severe thresholds, but the sources word the limit differently. The abstract says blood pressure below 160/100 mm Hg. The Methods required, at randomization, a systolic pressure of 140 to 159 or a diastolic pressure of 90 to 104 mm Hg for patients who “had not received an antihypertensive drug within 24 hours before measurement”, and below 160 and below 105 mm Hg for patients who “had been receiving antihypertensive therapy”. Women with lower pressures were also eligible. The registry gives a minimum age of 12 years and adds that the minimum age varies by center; the manuscript states no age limit.", "care_setting": "Recruiting sites of the CHAP Trial Consortium in the United States. The Methods say more than 70 recruiting sites; the Results say 2419 women were randomized at 61 sites. The manuscript does not say whether the sites were clinics or hospitals.", "geography": "United States", "life_stage": "Pregnancy, enrolled before 23 weeks of gestation and followed until 6 weeks after birth", "gestational_age_min_days": null, "gestational_age_max_days": 160, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Followed until 6 weeks after birth. Pre-eclampsia in the primary composite counted up to 2 weeks after birth.", "eligibility": { "inclusion": [ "Known chronic hypertension confirmed by a documented blood-pressure elevation and previous or current antihypertensive therapy, including lifestyle measures; or new chronic hypertension (systolic 140 mm Hg or higher or diastolic 90 mm Hg or higher on at least two occasions at least 4 hours apart before 20 weeks)", "A viable singleton fetus before 23 weeks of gestation", "Blood pressure below the severe-hypertension thresholds at randomization, as described in the population text" ], "exclusion": [ "Severe hypertension, or a blood pressure that needed more than one medication", "Known secondary hypertension", "Multiple fetuses", "Other serious illnesses or complications, named in advance, that might call for treatment at a lower blood pressure", "Obstetric conditions that increase fetal risk", "Contraindications to the first-line drugs recommended for use in pregnant women" ] } }, { "id": "maternal:ctx-emotive-vaginal-births-secondary-hospitals", "label": "Patients having vaginal delivery in 80 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania (E-MOTIVE)", "recipient": "maternal", "population": "Patients having a vaginal delivery in the study hospitals. Hospitals were randomly assigned to the package or to usual care. The abstract reports results among hospitals and patients with data, not for all randomised deliveries. The registry describes its research participants as health care providers attending vaginal births, a different basis from the paper.", "care_setting": "Secondary-level hospitals.", "geography": "Kenya, Nigeria, South Africa and Tanzania.", "life_stage": "Childbirth and the first hours after birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not stated in the abstract.", "eligibility": { "inclusion": [ "Patients having a vaginal delivery in a participating hospital" ], "exclusion": [ "Other criteria are not stated in the abstract" ] } }, { "id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "label": "Hospitalized for a hypertensive disorder of pregnancy, singleton pregnancy, 23 weeks 0 days to 34 weeks 6 days (US labelling of K241453)", "recipient": "maternal", "population": "Pregnant women with a singleton pregnancy, hospitalized for a hypertensive disorder of pregnancy (pre-eclampsia, chronic hypertension with or without superimposed pre-eclampsia, or gestational hypertension), at 23 weeks 0 days to 34 weeks 6 days.", "care_setting": "Hospital. The indication is for women hospitalized for the disorder.", "geography": "United States (FDA labelling)", "life_stage": "Pregnancy, 23 weeks 0 days to 34 weeks 6 days", "gestational_age_min_days": 161, "gestational_age_max_days": 244, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Two weeks from testing, the window in the indication for developing pre-eclampsia with severe features", "eligibility": { "inclusion": [ "Singleton pregnancy", "Hospitalized for a hypertensive disorder of pregnancy", "In the PRAECIS study that validated the cut-off: age 18 years or older, admitted to the hospital with a hypertensive disorder of pregnancy or developing one while hospitalized" ], "exclusion": [ "Not stated in the parts of the 510(k) summary that were read. The device type is not intended for diagnosis of any disease." ] } }, { "id": "maternal:ctx-global-maternal-deaths-2020", "label": "Maternal deaths worldwide in 2020 and women who experience postpartum haemorrhage each year (WHO 2023 estimates)", "recipient": "maternal", "population": "Women who died of maternal causes worldwide (2020 estimate) and women who experience postpartum haemorrhage each year (WHO estimate).", "care_setting": "Not stated in the source", "geography": "Worldwide. WHO says most deaths occurred in the world least developed countries.", "life_stage": "Pregnancy, childbirth and the postpartum period", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (burden estimate)", "eligibility": { "inclusion": [ "Maternal deaths and PPH episodes, as counted in the WHO estimates" ], "exclusion": [] } }, { "id": "maternal:ctx-global-maternal-deaths-who-2025", "label": "Maternal deaths worldwide and postpartum haemorrhage (WHO 2025 consolidated guideline)", "recipient": "maternal", "population": "Maternal deaths worldwide, with the share attributed to postpartum haemorrhage, and the share of related deaths in low- and middle-income countries.", "care_setting": "Not stated in the source", "geography": "Worldwide, with a focus on low- and middle-income countries, particularly in sub-Saharan Africa and South Asia.", "life_stage": "Pregnancy, childbirth and the postpartum period", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (burden statement). The 2025 text gives no year for its figures.", "eligibility": { "inclusion": [ "Maternal deaths, as counted by the sources WHO cites" ], "exclusion": [] } }, { "id": "maternal:ctx-ikmc-newborns-1000-1799g", "label": "Liveborn infants weighing 1.0 to under 1.8 kg at birth in five tertiary hospitals in sub-Saharan Africa and India (iKMC trial)", "recipient": "newborn", "population": "Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: \"between 1.0 and 1.799 kg\"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.", "care_setting": "Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.", "geography": "Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.", "life_stage": "Neonatal period", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": 0, "postnatal_age_max_days": 0, "gestational_age_status": "any", "postnatal_age_status": null, "followup_description": "From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.", "eligibility": { "inclusion": [ "Liveborn infant", "Birth weight 1.0 kg to under 1.8 kg", "Any gestational age, mode of delivery, or singleton or twin status", "Enrolled with the mother within 2 hours of birth" ], "exclusion": [ "Mother younger than 15 years", "Mother, or the guardian of a minor mother aged 15 to 17, unable or unwilling to consent", "Triplets or higher-order multiples", "Mother unlikely to provide KMC within the first 3 days (registry examples: eclampsia, shock, major surgery)", "Cannot be enrolled within 2 hours of birth", "Residence outside the study area", "Infant unable to breathe spontaneously by 1 hour of age", "Major congenital malformation (registry: one that interferes with, or is interfered with by, the intervention)" ] } }, { "id": "maternal:ctx-newborns-1000-1799g-high-resource-nicu", "label": "Hypothetical: infants of 1.0 to under 1.8 kg in high-resource neonatal intensive care units", "recipient": "newborn", "population": "A hypothetical population for an untested question: infants with a birth weight of 1.0 to under 1.8 kg, of any gestational age, cared for in high-resource neonatal intensive care units. The iKMC trial enrolled this weight band in five tertiary hospitals in Ghana, India, Malawi, Nigeria and Tanzania.", "care_setting": "High-resource neonatal intensive care units. Hypothetical: no result recorded in this atlas covers this setting.", "geography": "Not stated; hypothetical", "life_stage": "Neonatal period", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (hypothetical context)", "eligibility": { "inclusion": [ "Birth weight 1.0 kg to under 1.8 kg" ], "exclusion": [] } }, { "id": "maternal:ctx-nice-htg630-suspected-preterm-preeclampsia-20w-36w6d", "label": "Suspected preterm pre-eclampsia, 20 weeks to 36 weeks and 6 days (NICE HTG630)", "recipient": "maternal", "population": "People with suspected preterm pre-eclampsia between 20 weeks and 36 weeks and 6 days of pregnancy. NICE treats a woman who meets only part of the pre-eclampsia criteria as having suspected pre-eclampsia.", "care_setting": "Not stated as a setting. The guidance is for the NHS and describes testing used with standard clinical assessment.", "geography": "England (NHS). NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guidance page states no jurisdiction of its own. The guidance refers to routine use in the NHS.", "life_stage": "Pregnancy, 20 weeks to 36 weeks and 6 days", "gestational_age_min_days": 140, "gestational_age_max_days": 258, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Suspected preterm pre-eclampsia between 20 weeks and 36 weeks and 6 days of pregnancy" ], "exclusion": [ "Not stated as an exclusion. Separate recommendations advise against using the tests to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia, and advise using a test once for each episode of suspected preterm pre-eclampsia." ] } }, { "id": "maternal:ctx-nice-ng133-after-hdp-later-life", "label": "Women who have had a hypertensive disorder of pregnancy, later life (NICE NG133 recommendation 1.10.2)", "recipient": "maternal", "population": "Women who have had any hypertensive disorder of pregnancy (chronic hypertension, gestational hypertension or pre-eclampsia), compared by NICE with women who did not have one. The risks NICE reports are overall estimates drawn from several studies.", "care_setting": "Advice at transfer to community care after a hypertensive disorder of pregnancy.", "geography": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "life_stage": "Postpartum and later life", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "NICE gives no single follow-up time: it says follow-up in the underlying studies ranged from 1 to 40 years postpartum.", "eligibility": { "inclusion": [ "Women who have had a hypertensive disorder of pregnancy" ], "exclusion": [ "Not stated in the recommendation" ] } }, { "id": "maternal:ctx-nice-ng133-nulliparity-moderate-risk", "label": "Nulliparity as one moderate risk factor for pre-eclampsia (NICE NG133 recommendation 1.1.3)", "recipient": "maternal", "population": "Pregnant women with nulliparity, one of six factors that NICE lists as indicating moderate risk of pre-eclampsia. The NICE page does not define nulliparity.", "care_setting": "Not stated in the source.", "geography": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "life_stage": "Pregnancy. The source gives no gestational age for the risk factor itself.", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (risk factor context)", "eligibility": { "inclusion": [ "Pregnant woman with nulliparity" ], "exclusion": [ "Not stated in the recommendation text" ] } }, { "id": "maternal:ctx-nice-ng133-pregnant-high-risk-preeclampsia", "label": "Pregnant women at high risk of pre-eclampsia (NICE NG133 recommendation 1.1.2)", "recipient": "maternal", "population": "Pregnant women at high risk of pre-eclampsia, which NICE defines as having any one of five listed factors.", "care_setting": "Not stated in the source beyond two notes: community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine, and aspirin for this use must be prescribed.", "geography": "England. NICE's terms and conditions present the information on its websites as support for people in England (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "life_stage": "Pregnancy, from 12 weeks until the baby is born", "gestational_age_min_days": 84, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Hypertensive disease during a previous pregnancy", "Chronic kidney disease", "Autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome", "Type 1 or type 2 diabetes", "Chronic hypertension" ], "exclusion": [ "Not stated in the recommendation text" ] } }, { "id": "maternal:ctx-nice-ng133-pregnant-hypertension-on-treatment", "label": "Pregnant women with hypertension who are treated with medicines (NICE NG133 recommendation 1.3.9)", "recipient": "maternal", "population": "Pregnant women with hypertension who are being treated with medicines. The recommendation says hypertension in pregnancy and sits in the NICE section on chronic hypertension. NICE’s management tables for gestational hypertension (recommendation 1.4.3, Table 1) and pre-eclampsia (recommendation 1.5.5, Table 2) also give a target of 135/85 mmHg or less once on treatment. The NG133 Context chapter says the update did not review treatment for the three types of hypertension in pregnancy as one group. NICE defines hypertension as 140 mmHg systolic or higher, or 90 mmHg diastolic or higher, and severe hypertension as over 160 mmHg systolic or over 110 mmHg diastolic.", "care_setting": "Maternity care; the recommendation does not name a setting.", "geography": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "life_stage": "Pregnancy", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Pregnant women with hypertension who are using medicines to treat it" ], "exclusion": [ "Not stated in the recommendation" ] } }, { "id": "maternal:ctx-nice-ng133-pregnant-two-moderate-risk-factors", "label": "Pregnant women with more than one moderate risk factor for pre-eclampsia (NICE NG133 recommendation 1.1.3)", "recipient": "maternal", "population": "Pregnant women who have more than one of six moderate risk factors for pre-eclampsia that NICE lists.", "care_setting": "Not stated in the source beyond two notes: community pharmacies in England may not lawfully sell aspirin for pre-eclampsia prevention as a pharmacy medicine, and aspirin for this use must be prescribed.", "geography": "England. NICE's terms and conditions present the information on its websites as support for people in England (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "life_stage": "Pregnancy, from 12 weeks until the baby is born", "gestational_age_min_days": 84, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "More than one of the following moderate risk factors: nulliparity; age 40 years or older; pregnancy interval of more than 10 years; body mass index of 35 kg/m2 or more at the first visit; family history of pre-eclampsia; multi-fetal pregnancy" ], "exclusion": [ "Not stated in the recommendation text" ] } }, { "id": "maternal:ctx-who-2020-nonsevere-htn-pregnancy", "label": "Pregnant women with non-severe hypertension (WHO 2020 recommendation 1)", "recipient": "maternal", "population": "Pregnant women with non-severe hypertension. WHO uses non-severe and mild to moderate interchangeably and defines them as a diastolic pressure of 90 to 109 mmHg and/or a systolic pressure of 140 to 159 mmHg. The recommendation applies in the context of good quality antenatal care follow-up with regular outpatient monitoring and review.", "care_setting": "Antenatal care with regular outpatient monitoring and review by an antenatal care provider.", "geography": "Global; WHO states the audience as covering all settings.", "life_stage": "Pregnancy", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Women with non-severe hypertension during pregnancy, receiving good quality antenatal care follow-up" ], "exclusion": [ "Severe hypertension is outside this recommendation; WHO issues separate guidance on drug treatment for severe hypertension" ] } }, { "id": "maternal:ctx-who-2022-acs-chorioamnionitis", "label": "Women with chorioamnionitis who are likely to give birth preterm (WHO 2022, Recommendation 1.4)", "recipient": "maternal", "population": "Women with chorioamnionitis who are likely to give birth preterm. The recommendation text gives no gestational age bounds.", "care_setting": "Not stated in the source for this recommendation", "geography": "Global (WHO guideline)", "life_stage": "Pregnancy", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Chorioamnionitis", "Likely to give birth preterm" ], "exclusion": [] } }, { "id": "maternal:ctx-who-2022-acs-planned-caesarean-34w0d-36w6d", "label": "Women undergoing planned caesarean section at 34w0d to 36w6d (WHO 2022, Recommendation 1.5)", "recipient": "maternal", "population": "Women undergoing a planned caesarean section at 34 weeks 0 days to 36 weeks 6 days of gestation.", "care_setting": "Not stated in the source for this recommendation", "geography": "Global (WHO guideline)", "life_stage": "Pregnancy, late preterm", "gestational_age_min_days": 238, "gestational_age_max_days": 258, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Planned caesarean section", "Gestational age 34 weeks 0 days to 36 weeks 6 days" ], "exclusion": [] } }, { "id": "maternal:ctx-who-2022-acs-women-24w0d-34w0d", "label": "Women with a high likelihood of preterm birth from 24 weeks to 34 weeks of gestation, when five conditions are met (WHO 2022, Recommendation 1.0)", "recipient": "maternal", "population": "Women with a high likelihood of preterm birth within 7 days of starting therapy, from 24 weeks to 34 weeks 0 days of gestation. The woman receives the treatment and the preterm newborn is the intended beneficiary. The recommendation sets the lower limit at 24 weeks, and the Remarks set 34 weeks 0 days as the upper limit.", "care_setting": "Health-care facilities that can meet the five conditions, including accurate gestational age assessment, adequate childbirth care and adequate care of the preterm newborn. The Remarks say harm cannot be excluded where the conditions cannot be met, such as lower-level health facilities and the community level. They also say antenatal corticosteroids should not be routinely administered where ultrasound for gestational age assessment cannot be performed.", "geography": "Global (WHO guideline; no country is excluded, but the conditions must be met)", "life_stage": "Pregnancy", "gestational_age_min_days": 168, "gestational_age_max_days": 238, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Gestational age can be assessed accurately", "High likelihood of preterm birth within 7 days of starting therapy", "No clinical evidence of maternal infection", "Adequate childbirth care is available, including capacity to recognize and safely manage preterm labour and birth", "The preterm newborn can receive adequate care, including resuscitation, kangaroo mother care, thermal care, feeding support, infection treatment and respiratory support including continuous positive airway pressure (CPAP) as needed. WHO introduces the list with the word including, so it gives examples" ], "exclusion": [] } }, { "id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "label": "All women giving birth, blood-loss measurement and diagnostic criteria for the first 24 hours (WHO 2025 Recommendations 21 and 22)", "recipient": "maternal", "population": "All women giving birth. Recommendation 21 covers routine objective measurement. Recommendation 22 applies its criteria within 24 hours after birth, with particular vigilance in the first 2 hours. WHO says the available studies were in women giving birth vaginally and that the criteria have some limitations for caesarean section.", "care_setting": "Not stated in the source", "geography": "Global (WHO guidance intended to inform national and subnational policy).", "life_stage": "Childbirth and the first 24 hours after birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context). The diagnostic criteria apply within 24 hours after birth.", "eligibility": { "inclusion": [ "Any woman giving birth, by vaginal birth or caesarean section" ], "exclusion": [] } }, { "id": "maternal:ctx-who-2025-pph-prevention-at-birth", "label": "Women at vaginal or caesarean birth who are not yet bleeding enough to meet the PPH criteria (WHO 2025 Recommendations 14 and 15, prevention)", "recipient": "maternal", "population": "Women at vaginal birth (Recommendation 14) or caesarean birth (Recommendation 15), considered for tranexamic acid to prevent postpartum haemorrhage before significant bleeding begins. This is prevention and is a different use from treatment of PPH. WHO says the recommendations apply at the population level to all such births.", "care_setting": "Not stated in the source", "geography": "Global (WHO guidance intended to inform national and subnational policy).", "life_stage": "Childbirth, before significant bleeding", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Women at vaginal birth", "Women at caesarean birth" ], "exclusion": [ "Women who already have postpartum haemorrhage (treatment is a separate recommendation)" ] } }, { "id": "maternal:ctx-who-2025-pph-vaginal-birth", "label": "Women having a vaginal birth, objective assessment with a first-response bundle (WHO 2025 Recommendation 29)", "recipient": "maternal", "population": "All women having a vaginal birth. WHO says the supporting evidence comes largely from vaginal births in secondary-level facilities and that more research is needed to recommend bundle care at caesarean birth.", "care_setting": "Health facilities. The evidence is largely from secondary-level facilities; WHO says recognition and treatment are equally relevant in primary care, community and home settings.", "geography": "Global (WHO guidance intended to inform national and subnational policy).", "life_stage": "Childbirth and the first hours after birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Any woman having a vaginal birth" ], "exclusion": [] } }, { "id": "maternal:ctx-who-2025-pph-women-with-pph", "label": "Women with postpartum haemorrhage after vaginal or caesarean birth, treated within 3 hours of birth (WHO 2025 Recommendation 27)", "recipient": "maternal", "population": "Women with postpartum haemorrhage after vaginal birth or caesarean section. WHO aligns the diagnosis with its objective criteria (Recommendations 21 and 22) and no longer relies on clinical estimation alone, so this population is not identical to the clinically diagnosed women in WOMAN. Treatment is started within 3 hours of birth, counted from the time of birth.", "care_setting": "Settings where emergency obstetric care is provided. Intravenous use only.", "geography": "Global (WHO guidance intended to inform national and subnational policy).", "life_stage": "Postpartum, within 3 hours of birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Postpartum haemorrhage after vaginal birth or caesarean section" ], "exclusion": [ "A clear contraindication to antifibrinolytic therapy, for example a known thromboembolic event during pregnancy (WHO remarks)", "More than 3 hours after birth (WHO does not support use then)" ] } }, { "id": "maternal:ctx-who-preterm-or-lbw-infants", "label": "Preterm or low-birth-weight infants (WHO 2022 guideline population)", "recipient": "newborn", "population": "Preterm or low-birth-weight infants. This is broader than the iKMC trial's 1.0 to under 1.8 kg band.", "care_setting": "Health-care facility or home. The A.1b remarks give separate conditions for each.", "geography": "Global (WHO guideline; the setting text says \"any country or setting\")", "life_stage": "Newborn, from birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": 0, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Preterm or low-birth-weight infant" ], "exclusion": [ "In a facility: an infant who cannot breathe spontaneously after resuscitation, is in shock or needs mechanical ventilation. Otherwise immediate KMC can start before the infant is clinically stable.", "At home: an infant with danger signs, since home KMC is for infants without danger signs" ] } }, { "id": "maternal:ctx-woman-treated-within-3h", "label": "Women in WOMAN who received the trial treatment within 3 hours of giving birth (pre-specified subgroup)", "recipient": "maternal", "population": "The subgroup of WOMAN women treated within 3 hours of giving birth. The trial pre-specified subgroup analyses of death due to bleeding by the time interval between giving birth and treatment, as a protocol change made before un-blinding. The same eligibility applies as for the whole trial. The comparison with later treatment is given in the same claim.", "care_setting": "Hospitals (193 in the paper).", "geography": "Hospitals in 21 countries, as for the whole trial.", "life_stage": "Postpartum, within 3 hours of birth", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first.", "eligibility": { "inclusion": [ "WOMAN-eligible woman", "Treatment started within 3 hours of giving birth" ], "exclusion": [ "Women treated more than 3 hours after birth are the comparison subgroup, not part of this context" ] } }, { "id": "maternal:ctx-woman-women-16plus-clinical-pph", "label": "Women aged 16 or older with clinically diagnosed postpartum haemorrhage after vaginal or caesarean birth, in 193 hospitals in 21 countries (WOMAN)", "recipient": "maternal", "population": "Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage after a vaginal birth or caesarean section. WOMAN specified that the diagnosis could rest on clinically estimated blood loss of more than 500 mL after vaginal birth or 1000 mL after caesarean section, or any blood loss sufficient to compromise haemodynamic stability. This is the trial eligibility wording, not a WHO definition. The fundamental eligibility criterion was the clinician uncertainty about whether to use tranexamic acid in that woman. The overall result covers every treatment time.", "care_setting": "Hospitals (193 in the paper).", "geography": "Hospitals in 21 countries. The paper site list names Nigeria, Pakistan, Uganda, Kenya, Cameroon, Sudan, United Kingdom, Tanzania, Nepal, Zambia, Albania, Democratic Republic of Congo, Bangladesh, Ethiopia, Burkina Faso, Jamaica, Ghana, Papua New Guinea, Egypt, Colombia and Cote d'Ivoire.", "life_stage": "Postpartum, treated within hours of birth or later", "gestational_age_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first.", "eligibility": { "inclusion": [ "Aged 16 years or older", "Clinical diagnosis of postpartum haemorrhage after vaginal birth or caesarean section", "Responsible clinician uncertain whether to use tranexamic acid for this woman" ], "exclusion": [ "The registry (ISRCTN) lists a clear indication for antifibrinolytic therapy, as judged by the responsible doctor", "The registry (ISRCTN) lists a clear contraindication to antifibrinolytic therapy", "The paper text gives no other exclusion criteria" ] } } ], "sources": [ { "id": "maternal:action-i-anzctr", "source_type": "registry", "title": "The WHO ACTION-I (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trial", "canonical_url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000476336", "identifier_namespace": "anzctr", "identifier_value": "ACTRN12617000476336", "publication_date": null, "publisher": "Australian New Zealand Clinical Trials Registry", "edition": "Record as last updated 2021-03-22 (22/03/2021 on the page). Registered 2017-03-31 (31/03/2017) and marked as prospectively registered. Dates on the page are day/month/year.", "reuse_basis": "Short factual extraction. The page states that all rights are reserved and lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the page states all rights reserved, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:anzctr-actrn12617000476336-2026-10-11", "retrieved_at": "2026-10-11T19:10:33Z", "content_hash": "d43f7def2bdadf8c303488d8b03f6500f3786ed227e6232872ca447906b69d98", "source_effective_date": "2021-03-22", "public_archive_url": null, "source_state": "current" }, { "id": "maternal:anzctr-actrn12617000476336-2026-10-12", "retrieved_at": "2026-10-12T13:10:06Z", "content_hash": "0eeb31c3c80c691da588dbbcd774de5402bfc7656f95b3c6957beecfcc7ea029", "source_effective_date": "2021-03-22", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:action-i-ctri", "source_type": "registry", "title": "Improving newborn survival in preterm birth", "canonical_url": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17527", "identifier_namespace": "ctri", "identifier_value": "CTRI/2017/04/008326", "publication_date": null, "publisher": "Clinical Trials Registry - India, read through the WHO ICTRP mirror", "edition": "WHO ICTRP mirror, refreshed 2021-11-24 (24 November 2021). Registered 2017-04-10, read as day-month-year because the CTRI number contains 2017/04; ICTRP marks it as prospectively registered. The primary CTRI record could not be read on 2026-10-11: the http request did not connect and the https request returned a short error page.", "reuse_basis": "Short factual extraction from the ICTRP mirror, not the primary register. The page lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the terms of the CTRI record, read through the WHO ICTRP mirror, are unverified, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:ictrp-ctri-2017-04-008326-2026-10-11", "retrieved_at": "2026-10-11T19:10:34Z", "content_hash": "f80b7fcc0c2ca4a7ed56c92219e38fce42bacec3a4baef8335ed9806e6635485", "source_effective_date": "2021-11-24", "public_archive_url": null, "source_state": "unknown" }, { "id": "maternal:ictrp-ctri-2017-04-008326-2026-10-12", "retrieved_at": "2026-10-12T13:10:04Z", "content_hash": "769509ccb1a9b3c35c04d87f248b5a1431cc0ce75be0e1bdb8e67a9a3e493b23", "source_effective_date": "2021-11-24", "public_archive_url": null, "source_state": "unknown" } ] }, { "id": "maternal:action-i-nejm-2020", "source_type": "publication", "title": "Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries", "canonical_url": "https://doi.org/10.1056/NEJMoa2022398", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa2022398", "publication_date": "2020-12-24", "publisher": "Massachusetts Medical Society (N Engl J Med 383(26):2514-2525)", "edition": "Version of record not fetched (HTTP 403 on 2026-10-11). The abstract comes from PubMed and the bibliographic data from Crossref. Full-text facts come from the PMC Author Final Manuscript PMC7660991. Tables and figures were read in that manuscript and not checked against the version of record. PubMed lists comments and letters on the article but no erratum or retraction.", "reuse_basis": "Bibliographic metadata and short factual extraction. The PMC Author Final Manuscript states that it is licensed for use under the CC BY license and is committed at research/snapshots/ma-pmc-PMC7660991.xml. Attribution: WHO ACTION Trials Collaborators, N Engl J Med 2020;383:2514-2525, doi:10.1056/NEJMoa2022398, Author Final Manuscript via PMC (PMC7660991). The version of record is not redistributed.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-33095526-2026-10-11", "retrieved_at": "2026-10-11T19:10:30Z", "content_hash": "adb2579c89c865461eb3f3ace681a011868a4f43b15a028d7178d08ad0d7057e", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:pmc-pmc7660991-2026-10-11", "retrieved_at": "2026-10-11T19:10:31Z", "content_hash": "8c795f040d84bf82311862509bdde4ea0f243d2933f596c1bd4f80ebdae14b26", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:crossref-nejmoa2022398-2026-10-11", "retrieved_at": "2026-10-11T19:10:33Z", "content_hash": "381d9b80f0758d4d706cd1e20bf8f4b08a3131cc09ff91e38cc3676939f67ead", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:chap-ctgov", "source_type": "registry", "title": "Chronic Hypertension and Pregnancy (CHAP) Project", "canonical_url": "https://clinicaltrials.gov/study/NCT02299414", "identifier_namespace": "nct", "identifier_value": "NCT02299414", "publication_date": null, "publisher": "ClinicalTrials.gov (U.S. National Library of Medicine)", "edition": "ClinicalTrials.gov API v2 JSON as retrieved on 2026-10-11; the record was last updated 2023-05-17 and has posted results.", "reuse_basis": "Short factual extraction. The JSON is not committed: the ClinicalTrials.gov terms page is rendered by JavaScript, so its reuse terms could not be read (label mb-ctgov-terms.html), and the record lists investigator names and locations. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. 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The version of record is not redistributed.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-35363951-2026-10-11", "retrieved_at": "2026-10-11T19:10:32Z", "content_hash": "0d4e3df2a54e7410e41088da17ab93607e2184d8c086a69f5d47053347f746fe", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:pmc-pmc9575330-2026-10-11", "retrieved_at": "2026-10-11T19:10:37Z", "content_hash": "ad310682ed3d8aaac7c162897fc3938d64372fc558622433e3c400aecde53559", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:crossref-nejmoa2201295-2026-10-11", "retrieved_at": "2026-10-11T19:13:06Z", "content_hash": "b94ae643cfdf3dda33d896860c853f018d4932fa3c028127956c54132726e331", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote", "snapshots": [ { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:emotive-ctgov", "source_type": "registry", "title": "A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth", "canonical_url": "https://clinicaltrials.gov/study/NCT04341662", "identifier_namespace": "nct", "identifier_value": "NCT04341662", "publication_date": null, "publisher": "ClinicalTrials.gov", "edition": "API v2 JSON, fetched on 2026-10-11. The record has posted results, which were not read.", "reuse_basis": "Registry JSON. ClinicalTrials.gov terms of use have not been verified, so the bytes are not committed. Facts only. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. This source's terms are unverified or reserve all rights, so any quotation stays short.", "public_text": "quote", "snapshots": [ { "id": "maternal:ctgov-nct04341662-2026-10-11", "retrieved_at": "2026-10-11T19:11:02Z", "content_hash": "0a7a1ede0bc051836032b9f2016627544ebe5a0c0093f178b25e94a4ab1a6a8f", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:emotive-nejm-2023", "source_type": "publication", "title": "Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage", "canonical_url": "https://doi.org/10.1056/NEJMoa2303966", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa2303966", "publication_date": "2023-07-06", "publisher": "Massachusetts Medical Society (N Engl J Med 389(1):11-21)", "edition": "Abstract only, from PubMed (PMID 37158447). The version of record returned HTTP 403 on 2026-10-11 and was not retrieved by any other route. No PMC full text exists, so the analysis methods are not described in any record.", "reuse_basis": "Bibliographic metadata and short factual extraction from the PubMed abstract. The abstract belongs to the publisher, so it is not committed; only its sha256 is kept.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-37158447-2026-10-11", "retrieved_at": "2026-10-11T19:11:01Z", "content_hash": "ac7a6b8ccd74b1e8eec860852401c1052be14e9cbe32a7f923b2be380a8662d0", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:fda-510k-k241453", "source_type": "regulator", "title": "FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241453", "identifier_namespace": "fda-510k", "identifier_value": "K241453", "publication_date": "2025-02-07", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-11. The openFDA device 510(k) JSON record (meta.last_updated 2026-09-28) gives the decision date, product code and decision. The 510(k) summary PDF (27 pages) holds FDA's clearance letter, the Indications for Use form and Roche's own 510(k) Summary. The accessdata pmn.cfm page was fetched too (fetch-log label mc-fda-pmn-k241453.html) and has no snapshot record. The openFDA classification record for product code QWH was fetched as well (mc-openfda-class-qwh.json) and is not used, because the eCFR text of 21 CFR 862.1602 is the primary source for the device type.", "reuse_basis": "The openFDA license page (fetched as mc-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The FDA website policies page (mc-fda-website-policies.html, sha256 e7cf15d3edf28bd645ce47acd2a96bde8eafab0743981949df0a79019d59a2b2) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mc-openfda-510k-k241453.json; it holds the applicant's business contact name exactly as FDA publishes it. The 510(k) summary PDF is Roche's submission text released by FDA, so only short quotations are used and its bytes are not committed.", "public_text": "quote", "snapshots": [ { "id": "maternal:openfda-510k-k241453-2026-10-11", "retrieved_at": "2026-10-11T19:11:37Z", "content_hash": "226daf5ac68fa70fb9c7b92eaea124452c9281d5fc313480099427453ac5126d", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:fda-510k-summary-k241453-2026-10-11", "retrieved_at": "2026-10-11T19:11:38Z", "content_hash": "edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00", "source_effective_date": "2025-02-07", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:fda-denovo-den220027", "source_type": "regulator", "title": "FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220027", "identifier_namespace": "fda-de-novo", "identifier_value": "DEN220027", "publication_date": null, "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names.", "reuse_basis": "The openFDA license page (fetched as mc-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The FDA website policies page (mc-fda-website-policies.html, sha256 e7cf15d3edf28bd645ce47acd2a96bde8eafab0743981949df0a79019d59a2b2) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mc-openfda-510k-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.", "public_text": "quote", "snapshots": [ { "id": "maternal:openfda-510k-den220027-2026-10-11", "retrieved_at": "2026-10-11T19:11:37Z", "content_hash": "bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:fda-denovo-page-den220027-2026-10-11", "retrieved_at": "2026-10-11T19:11:37Z", "content_hash": "57eea5005cef94c47b8914a4b55b54d12d81c152b8b4be04944b3a04add929cd", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:ikmc-anzctr", "source_type": "registry", "title": "Effect of immediate Kangaroo Mother Care on neonatal mortality for mothers and babies", "canonical_url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001880235", "identifier_namespace": "anzctr", "identifier_value": "ACTRN12618001880235", "publication_date": null, "publisher": "Australian New Zealand Clinical Trials Registry", "edition": "Record as last updated 2021-04-07. Submitted 2018-09-10 and registered 2018-11-19, marked as retrospectively registered. Universal trial number U1111-1219-1230.", "reuse_basis": "Short factual extraction. The page states that all rights are reserved, and lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the page states all rights reserved, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:anzctr-actrn12618001880235-2026-10-09", "retrieved_at": "2026-10-09T15:57:53Z", "content_hash": "3db33e1ff7a7695daedf52ac75f4a3dcdd1a7a29cd4bf650354891f0b8cceb11", "source_effective_date": "2021-04-07", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:ikmc-ctri", "source_type": "registry", "title": "Immediate skin to skin contact of the baby with mother or the surrogate", "canonical_url": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21832", "identifier_namespace": "ctri", "identifier_value": "CTRI/2018/08/015369", "publication_date": null, "publisher": "Clinical Trials Registry - India, read through the WHO ICTRP mirror", "edition": "WHO ICTRP mirror, last refreshed on 24 November 2021. Registered 2018-08-17 (ICTRP marks it as not prospectively registered). The primary CTRI record could not be fetched: the http request timed out and the https request redirected to an error page.", "reuse_basis": "Short factual extraction from the ICTRP mirror, not the primary register. The page lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the terms of the CTRI record, read through the WHO ICTRP mirror, are unverified, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:ictrp-ctri-2018-08-015369-2026-10-09", "retrieved_at": "2026-10-09T15:58:10Z", "content_hash": "ca9ae31bf890b23b30bf87167bc3cb5876db63618b15f9ad0c3658270c549e4c", "source_effective_date": "2021-11-24", "public_archive_url": null, "source_state": "unknown" } ] }, { "id": "maternal:ikmc-nejm-2021", "source_type": "publication", "title": "Immediate \"Kangaroo Mother Care\" and Survival of Infants with Low Birth Weight", "canonical_url": "https://doi.org/10.1056/NEJMoa2026486", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa2026486", "publication_date": "2021-05-27", "publisher": "Massachusetts Medical Society (N Engl J Med 384(21):2028-2038)", "edition": "Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485.", "reuse_basis": "Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-34038632-2026-10-09", "retrieved_at": "2026-10-09T15:56:27Z", "content_hash": "5dde5eaa4d684f398f7f3cfab05816eb73207b8adbaac5c4163e7e480567ecf6", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:pmc-pmc8108485-2026-10-09", "retrieved_at": "2026-10-09T15:57:07Z", "content_hash": "0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:crossref-nejmoa2026486-2026-10-09", "retrieved_at": "2026-10-09T15:57:09Z", "content_hash": "5a2e169855caa99fe1eff24a293fb7ca476e0493a75659a09159ba716f6af619", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:mesh-d002821", "source_type": "dataset", "title": "MeSH descriptor D002821 (Chorioamnionitis)", "canonical_url": "https://id.nlm.nih.gov/mesh/D002821", "identifier_namespace": "mesh", "identifier_value": "D002821", "publication_date": null, "publisher": "U.S. National Library of Medicine", "edition": "MeSH linked-data descriptor record with lastUpdated 2021-06-30, as fetched on 2026-10-12, and its preferred concept record M0004338, which holds the scope note used for the plain-language gloss of chorioamnionitis. The records state no yearly MeSH release.", "reuse_basis": "The NLM web policies page, fetched on 2026-10-12 as ma-nlm-web-policies.html (sha256 c8b7026b5c3fcfd1b0cb88755077f6a99a5f2159eecd42b0e7d1a5ad9b30ec55), says works produced by the U.S. government are not subject to copyright protection in the United States and asks users to acknowledge NLM as the source. Source: National Library of Medicine. Only one short scope note is quoted and the bytes are not committed.", "public_text": "quote", "snapshots": [ { "id": "maternal:mesh-d002821-2026-10-12", "retrieved_at": "2026-10-12T12:56:10Z", "content_hash": "5a07969eb901d12b24e454596c38c1261a176ef60bce7f7e5d862299062d3bd1", "source_effective_date": "2021-06-30", "public_archive_url": null, "source_state": "current" }, { "id": "maternal:mesh-m0004338-2026-10-12", "retrieved_at": "2026-10-12T12:56:25Z", "content_hash": "0976260c6de8346496fc8377c4da5415e48665db8f61cf74f67037f5b432fdb1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:mesh-m0015959", "source_type": "dataset", "title": "MeSH concept M0015959 (Parity)", "canonical_url": "https://id.nlm.nih.gov/mesh/M0015959", "identifier_namespace": "mesh-concept", "identifier_value": "M0015959", "publication_date": null, "publisher": "U.S. National Library of Medicine", "edition": "MeSH linked-data concept record as fetched on 2026-10-11. It holds the scope note and the list of narrower concepts, and states no date.", "reuse_basis": "The NLM web policies page (fetched as mc-nlm-web-policies.html, sha256 c8b7026b5c3fcfd1b0cb88755077f6a99a5f2159eecd42b0e7d1a5ad9b30ec55) says works produced by the U.S. government are not subject to copyright protection in the United States and asks users to acknowledge NLM as the source. Source: National Library of Medicine. The NLM terms and conditions page (mc-nlm-terms.html, sha256 f1fb494447a54d2190e496410163c8e1fc138a601d83d8c124f267f7103026b3) asks redistributors to maintain the most current data or to make known clearly that their copy may not reflect the most current data available from NLM. This copy was fetched on 2026-10-11 and may not reflect the most current data. The raw bytes are committed at research/snapshots/mc-mesh-M0015959.json.", "public_text": "quote", "snapshots": [ { "id": "maternal:mesh-m0015959-2026-10-11", "retrieved_at": "2026-10-11T19:15:23Z", "content_hash": "aa475bcc0d87b166a854aa3561a27082f8367683a553c1373d3e85a550aeadf4", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:nice-htg630-overview-2026-10-11", "retrieved_at": "2026-10-11T19:10:53Z", "content_hash": "e9bfd21573bac4a7a5269ae55ef93157c0a3ceb35d8125cb00d2eb7e6dd5fc12", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:nice-ng133-context", "source_type": "guideline", "title": "Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Context chapter", "canonical_url": "https://www.nice.org.uk/guidance/ng133/chapter/Context", "identifier_namespace": null, "identifier_value": null, "publication_date": "2019-06-25", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Another chapter of NICE guideline NG133, which has no identifier of its own because the Recommendations chapter source already holds the identifier NG133. The version shown on 2026-10-11. NICE lists the guideline as last updated 17 April 2023 and also lists minor changes in October 2023 (see the Update information chapter).", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms, read on 2026-10-11 and recorded in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the page, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:nice-ng133-context-2026-10-11", "retrieved_at": "2026-10-11T19:12:47Z", "content_hash": "b664aadc0a8aab948b2a376dee01b23b8c068f5c7c7e3a849c3140fce4a3dd72", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:nice-ng133-update-info", "source_type": "guideline", "title": "Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Update information chapter", "canonical_url": "https://www.nice.org.uk/guidance/ng133/chapter/Update-information", "identifier_namespace": null, "identifier_value": null, "publication_date": "2019-06-25", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "The Update information chapter of NICE guideline NG133, as shown on 2026-10-11 with the page header Last updated: 17 April 2023. It lists what changed in June 2019, the minor changes after publication (August 2022, April 2023 and October 2023) and the guideline ISBN. The chapter has no identifier of its own because the Recommendations chapter source already holds the identifier NG133. Cluster B and cluster C fetched this page separately on 2026-10-11 and both returned the same bytes (sha256 248348547ec88c3384b6fb76489a433766acf40e47b5f77d8060516561836a58). The integration step kept this one source and snapshot and redirected the cluster C citations to them.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms, read on 2026-10-11 and recorded in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the page, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:nice-ng133-update-info-2026-10-11", "retrieved_at": "2026-10-11T19:16:21Z", "content_hash": "248348547ec88c3384b6fb76489a433766acf40e47b5f77d8060516561836a58", "source_effective_date": "2023-04-17", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:nice-ng133", "source_type": "guideline", "title": "Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Recommendations chapter", "canonical_url": "https://www.nice.org.uk/guidance/ng133/chapter/Recommendations", "identifier_namespace": "nice", "identifier_value": "NG133", "publication_date": "2019-06-25", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "The version shown on 2026-10-11, with a page header that gives 17 April 2023 as the last update. The same bytes came back on a second fetch minutes later.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms, read on 2026-10-11: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the page, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording.", "public_text": "cite_only", "snapshots": [ { "id": "maternal:nice-ng133-recs-2026-10-11", "retrieved_at": "2026-10-11T18:19:40Z", "content_hash": "0cd8548f5807f03a82b3101dc56ebadf674106da9d0aa7e57955d4a823556fca", "source_effective_date": "2023-04-17", "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2017-txa-pph", "source_type": "guideline", "title": "WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage", "canonical_url": "https://www.who.int/publications/i/item/9789241550154", "identifier_namespace": "isbn", "identifier_value": "978-92-4-155015-4", "publication_date": "2017-11-28", "publisher": "World Health Organization", "edition": "2017. The date is the who.int page date, 28 November 2017, which the atlas uses for WHO sources and decisions; the WHO IRIS record lists an issue date of 2017-10-27 for the same document. History only: WHO integrated this recommendation into its 2025 consolidated guideline as Recommendation 27, labelled Edited, so the 2025 document carries the current decision. The PDF has font-encoding garbage in its Remarks paragraphs, so only clean text is used.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF and in the IRIS record. Only short quotations with attribution are used, and neither the PDF nor the pages are committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789241550154-2026-10-11", "retrieved_at": "2026-10-11T19:11:09Z", "content_hash": "e5de5b16865e4da338a125dffc923561b23d30ae173a76e89d32efcf054eb535", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-10665-259374-2026-10-11", "retrieved_at": "2026-10-11T19:11:11Z", "content_hash": "264ce7edcb3fcd26d9b552006e103f517d7737f2bff69017ccb67e83c8a0f724", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789241550154-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:12:03Z", "content_hash": "b19ff1c62e7725cb8a0c488ff85135894d95c281583e4d5b5e911afa3ff99723", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2020-nonsevere-htn", "source_type": "guideline", "title": "WHO recommendations on drug treatment for non-severe hypertension in pregnancy", "canonical_url": "https://www.who.int/publications/i/item/9789240008793", "identifier_namespace": "isbn", "identifier_value": "978-92-4-000879-3", "publication_date": "2020-08-11", "publisher": "World Health Organization", "edition": "2020. The WHO publication page shows 11 August 2020; the IRIS record (handle 10665/333816) gives an issue date of 2020-08-13. The text comes from the PDF on IRIS, fetched through the IRIS REST API because the older IRIS bitstream links no longer serve the PDF. Electronic ISBN 978-92-4-000879-3. The guideline predates the CHAP report (2022). Whether WHO has issued a newer recommendation was not checked here.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF. Only short quotations with attribution are used, and the PDF is not committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789240008793-2026-10-11", "retrieved_at": "2026-10-11T19:10:40Z", "content_hash": "48f25b63157732c9511cf5fe4c8be448caa5a2c05e26854425a96f802ece40ed", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-9789240008793-2026-10-11", "retrieved_at": "2026-10-11T19:12:01Z", "content_hash": "32c88118c5f924d5bb642e5ecf3f7940196c8e52bdfdf8b8a9231b951e6b9306", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789240008793-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:12:18Z", "content_hash": "d21df49f3ed9eb5ad34f211d0f7921332c514c652923730bd92167610d9d7358", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2021-antiplatelet", "source_type": "guideline", "title": "WHO recommendations on antiplatelet agents for the prevention of pre-eclampsia", "canonical_url": "https://www.who.int/publications/i/item/9789240037540", "identifier_namespace": "isbn", "identifier_value": "978-92-4-003754-0", "publication_date": "2021-12-06", "publisher": "World Health Organization", "edition": "2021, electronic edition. The PDF (81 pages) came from WHO IRIS handle 10665/350190 through the IRIS REST API content endpoint (bitstream 76d9febc-540a-4a2e-8664-237f523a3e47), because the older apps.who.int links no longer return the PDF. The who.int publication page supplied the date.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF. Only short quotations with attribution are used, and the PDF is not committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-2021-antiplatelet-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:15:07Z", "content_hash": "98c96df70c4a3ad168f56ffcea73cd3cba2626474ff0e541412f7c81704eadd3", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-pub-9789240037540-2026-10-11", "retrieved_at": "2026-10-11T19:18:12Z", "content_hash": "11e3e6668cd5c04022211f8cbf49385d10337b6e8408b8cbb9ea41a16a4fa410", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2022-acs", "source_type": "guideline", "title": "WHO recommendations on antenatal corticosteroids for improving preterm birth outcomes", "canonical_url": "https://www.who.int/publications/i/item/9789240057296", "identifier_namespace": "isbn", "identifier_value": "978-92-4-005729-6", "publication_date": "2022-09-29", "publisher": "World Health Organization", "edition": "2022. Electronic ISBN 978-92-4-005729-6; print ISBN 978-92-4-005730-2. The who.int page shows 29 September 2022 and the WHO IRIS record 10665/363131 lists an issue date of 2022-09-23; both are kept. The PDF was read from IRIS because the PDF link on the who.int page does not return the PDF.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF. Only short quotations with attribution are used, and neither the PDF nor the page is committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789240057296-2026-10-11", "retrieved_at": "2026-10-11T19:10:36Z", "content_hash": "4fbf23c4d5cd064761bd038cfdf803e37c68411ff8024dcb45fa6ce6c0ad82a6", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789240057296-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:11:20Z", "content_hash": "5005890cdc3ec2531d62aefaada7e5f2a9ac8adf5d75ec94ffe35fe133fe7f20", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-10665-363131-2026-10-11", "retrieved_at": "2026-10-11T19:10:41Z", "content_hash": "b9aa6fac20733926b80a80df11748a6360e0b0cc61d2dbf5e32e959470ec730d", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2022-preterm-lbw", "source_type": "guideline", "title": "WHO recommendations for care of the preterm or low-birth-weight infant", "canonical_url": "https://www.who.int/publications/i/item/9789240058262", "identifier_namespace": "isbn", "identifier_value": "978-92-4-005826-2", "publication_date": "2022-11-15", "publisher": "World Health Organization", "edition": "2022. Electronic ISBN 978-92-4-005826-2; print ISBN 978-92-4-005827-9. The who.int page shows 15 November 2022 and the WHO IRIS record 10665/363697 lists an issue date of 2022-10-21; both are kept, and the decisions use the who.int date.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF. Only short quotations with attribution are used, and the PDF is not committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789240058262-2026-10-09", "retrieved_at": "2026-10-09T15:58:12Z", "content_hash": "df078106ea2ee42fc11aea82ad976fe6cd1041ef3aee8b9a5967ed75419edf9e", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789240058262-pdf-2026-10-09", "retrieved_at": "2026-10-09T15:58:39Z", "content_hash": "650354ec6f6cfdc81bd9b542ef488eb32de0d2675cdc574fd26a529c2275d532", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-pub-9789240058262-2026-10-11", "retrieved_at": "2026-10-11T17:24:27Z", "content_hash": "5bd12b641a0d04504fbf366e34afa75c191c1a6da127f0b434b956495acb37bc", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-10665-363697-2026-10-12", "retrieved_at": "2026-10-12T13:31:54Z", "content_hash": "5de45c261431bb0b97cf599484eedca883458fcfc71135ef2fa1900e706ac18b", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2023-pph-bundle", "source_type": "guideline", "title": "WHO recommendations on the assessment of postpartum blood loss and use of a treatment bundle for postpartum haemorrhage", "canonical_url": "https://www.who.int/publications/i/item/9789240085398", "identifier_namespace": "isbn", "identifier_value": "978-92-4-008539-8", "publication_date": "2023-12-21", "publisher": "World Health Organization", "edition": "2023. History and burden figures only: WHO integrated Recommendations 1 and 2 of this document into its 2025 consolidated guideline unchanged, as Recommendations 21 and 29, so the 2025 document carries the current decisions.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF and in the IRIS record. Only short quotations with attribution are used, and neither the PDF nor the pages are committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789240085398-2026-10-11", "retrieved_at": "2026-10-11T19:11:08Z", "content_hash": "54e5c5c89e955c42dd7a0007fe696bbe7892bf029a82c35b478ce88cbc071220", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-10665-375231-2026-10-11", "retrieved_at": "2026-10-11T19:11:10Z", "content_hash": "f588a88362bc7f37d0c3a67a2a2b1aeeec955370d373632ed4ca2bf436be0e0d", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789240085398-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:12:01Z", "content_hash": "36364aa61f4e3b6dc00561e5a5d6aff380639230952bda6cab1db58d81c66ad8", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:who-2025-pph-consolidated", "source_type": "guideline", "title": "Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage", "canonical_url": "https://www.who.int/publications/i/item/9789240115637", "identifier_namespace": "isbn", "identifier_value": "978-92-4-011563-7", "publication_date": "2025-10-05", "publisher": "World Health Organization, co-published with the International Federation of Gynecology and Obstetrics (FIGO) and the International Confederation of Midwives (ICM)", "edition": "First edition, 2025. The date is the who.int page date, 5 October 2025, which the atlas uses for WHO sources and decisions; the WHO IRIS record lists an issue date of 2025-09-26 for the same document. The web annexes with the evidence base and the implementation guide were not read.", "reuse_basis": "Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF and in the IRIS record. Only short quotations with attribution are used, and neither the PDF nor the pages are committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.", "public_text": "quote", "snapshots": [ { "id": "maternal:who-pub-9789240115637-2026-10-11", "retrieved_at": "2026-10-11T19:11:07Z", "content_hash": "3b1ddf6ab12864af650ff62ccb333032d563804d4a43489b2e725dd5b7f9dd2c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:iris-10665-382923-2026-10-11", "retrieved_at": "2026-10-11T19:11:10Z", "content_hash": "8d1bc7661a1d5ed1fd413a0bee4e34896e986e06d1eb987d22eea31b9847687f", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:who-9789240115637-pdf-2026-10-11", "retrieved_at": "2026-10-11T19:12:00Z", "content_hash": "2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:woman-ctgov", "source_type": "registry", "title": "World Maternal Antifibrinolytic Trial", "canonical_url": "https://clinicaltrials.gov/study/NCT00872469", "identifier_namespace": "nct", "identifier_value": "NCT00872469", "publication_date": null, "publisher": "ClinicalTrials.gov", "edition": "API v2 JSON, fetched on 2026-10-11. The record holds no posted results (the API reports hasResults false), so every finding comes from the publication.", "reuse_basis": "Registry JSON. ClinicalTrials.gov terms of use have not been verified, so the bytes are not committed. Facts only. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. This source's terms are unverified or reserve all rights, so any quotation stays short.", "public_text": "quote", "snapshots": [ { "id": "maternal:ctgov-nct00872469-2026-10-11", "retrieved_at": "2026-10-11T19:11:02Z", "content_hash": "8eba9d5bfcc1a28e8ef630b93e9d9c3e58031cb42085c05daaccb503252a1310", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:woman-lancet-2017-erratum", "source_type": "publication", "title": "Department of Error (correction to the WOMAN trial report)", "canonical_url": "https://doi.org/10.1016/S0140-6736(17)31220-5", "identifier_namespace": "doi", "identifier_value": "10.1016/S0140-6736(17)31220-5", "publication_date": "2017-05-27", "publisher": "Elsevier (The Lancet 389(10084):2104)", "edition": "PubMed record (PMID 28483296) and the PMC open-access text of the erratum (PMC6891225). The publication date is the print issue date.", "reuse_basis": "PMC6891225 is open access under CC BY-NC-ND 4.0, as its own XML states. Short quotation with attribution; the XML is not committed.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-28483296-2026-10-11", "retrieved_at": "2026-10-11T19:10:59Z", "content_hash": "e5feda8bd3a67e99af8fbc3afdc60a1cb14f7afbce002be4232676b518eb71d2", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, { "id": "maternal:pmc-pmc6891225-2026-10-11", "retrieved_at": "2026-10-11T19:11:00Z", "content_hash": "4d208f181f5cdbc06acf1817fcc38b5c0f1aa32848784237eed45c1e13fbbf6d", "source_effective_date": null, "public_archive_url": null, "source_state": "current" } ] }, { "id": "maternal:woman-lancet-2017", "source_type": "publication", "title": "Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial", "canonical_url": "https://doi.org/10.1016/S0140-6736(17)30638-4", "identifier_namespace": "doi", "identifier_value": "10.1016/S0140-6736(17)30638-4", "publication_date": "2017-05-27", "publisher": "Elsevier (The Lancet 389(10084):2105-2116)", "edition": "Abstract from PubMed (PMID 28456509). Full-text facts come from PMC5446563, the open-access version of record, which carries the online correction of 5 May 2017 described in maternal:woman-lancet-2017-erratum. Figure 3 (death from bleeding by subgroup) is a separate image on the PMC figure page, snapshotted as its own bytes because its numbers are not in the XML. The publication date is the print issue date; PubMed also lists an electronic date of 2017-04-26.", "reuse_basis": "PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.", "public_text": "quote", "snapshots": [ { "id": "maternal:pubmed-28456509-2026-10-11", "retrieved_at": "2026-10-11T19:10:56Z", "content_hash": "e734360d2becdd1091cac4214a571195ec245318bbcc57203b4aefce56222f3a", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, { "id": "maternal:pmc-pmc5446563-2026-10-11", "retrieved_at": "2026-10-11T19:10:57Z", "content_hash": "6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, { "id": "maternal:pmc-pmc5446563-fig3-2026-10-12", "retrieved_at": "2026-10-12T13:07:47Z", "content_hash": "fe0cb41cfd6fbcbb55fc2536569de36ed1641ca9ce90f4310ef13db7d5241fcc", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" } ] } ], "decisions": [ { "type": "recommendation", "id": "maternal:rec-nice-htg630-1-1", "direction": "for", "intervention_id": "maternal:plgf-based-testing", "context_id": "maternal:ctx-nice-htg630-suspected-preterm-preeclampsia-20w-36w6d", "guideline_snapshot_id": "maternal:nice-htg630-recs-2026-10-11", "issuer_id": "maternal:nice", "jurisdiction": "England (NICE HealthTech guidance for the NHS). NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guidance page states no jurisdiction of its own.", "strength_label": "Recommended (no graded strength label)", "strength_system": "NICE HealthTech guidance wording, which recommends or does not recommend a test. The page gives no GRADE rating for recommendation 1.1.", "effective_date": "2022-07-27", "effective_date_note": "The guidance was published as diagnostics guidance 49 and later migrated to HealthTech guidance 630 with its recommendations unchanged.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-nice-htg630-1-1" }, { "type": "recommendation", "id": "maternal:rec-nice-ng133-1-1-2", "direction": "for", "intervention_id": "maternal:low-dose-aspirin-preeclampsia-prevention", "context_id": "maternal:ctx-nice-ng133-pregnant-high-risk-preeclampsia", "guideline_snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "issuer_id": "maternal:nice", "jurisdiction": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "strength_label": "Advise (no graded strength label on the page)", "strength_system": "NICE guideline wording, in which the verb shows the strength of a recommendation. The page points to a separate NICE document that explains how, and gives no GRADE rating for this recommendation.", "effective_date": "2019-06-25", "effective_date_note": "The recommendation is tagged [2010, amended 2019]. 25 June 2019 is the guideline's publication date, which is when the 2019 amendments were made. The page was last updated on 17 April 2023 for other recommendations.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-nice-ng133-1-1-2-aspirin-high-risk" }, { "type": "recommendation", "id": "maternal:rec-nice-ng133-1-1-3", "direction": "for", "intervention_id": "maternal:low-dose-aspirin-preeclampsia-prevention", "context_id": "maternal:ctx-nice-ng133-pregnant-two-moderate-risk-factors", "guideline_snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "issuer_id": "maternal:nice", "jurisdiction": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "strength_label": "Advise (no graded strength label on the page)", "strength_system": "NICE guideline wording, in which the verb shows the strength of a recommendation. The page points to a separate NICE document that explains how, and gives no GRADE rating for this recommendation.", "effective_date": "2019-06-25", "effective_date_note": "The recommendation is tagged [2010, amended 2019]. 25 June 2019 is the guideline's publication date, which is when the 2019 amendments were made. The page was last updated on 17 April 2023 for other recommendations. Wording corrected in August 2022 (first pregnancy to nulliparity); the effective date stays 2019-06-25.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-nice-ng133-1-1-3-aspirin-moderate-risk" }, { "type": "recommendation", "id": "maternal:rec-nice-ng133-1-3-9", "direction": "for", "intervention_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-nice-ng133-pregnant-hypertension-on-treatment", "guideline_snapshot_id": "maternal:nice-ng133-recs-2026-10-11", "issuer_id": "maternal:nice", "jurisdiction": "England. NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guideline page states no jurisdiction of its own.", "strength_label": "No labelled strength (imperative wording: aim for a target)", "strength_system": "NICE shows strength through its choice of words, as its guidance on making decisions explains; this recommendation carries no separate strength label and no certainty rating.", "effective_date": "2019-06-25", "effective_date_note": "The recommendation is marked [2019]; 25 June 2019 is the guideline publication date. The page was last updated on 17 April 2023, and the update information does not list 1.3.9 as changed.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-nice-ng133-1-3-9-target" }, { "type": "recommendation", "id": "maternal:rec-who-2020-nonsevere-htn-1", "direction": "for", "intervention_id": "maternal:antihypertensive-treatment-non-severe-hypertension-pregnancy", "context_id": "maternal:ctx-who-2020-nonsevere-htn-pregnancy", "guideline_snapshot_id": "maternal:who-9789240008793-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guideline stated for all settings)", "strength_label": "Context specific recommendation", "strength_system": "WHO guideline method with GRADE. The PDF defines the categories recommended, not recommended, recommended only in specific contexts and recommended only in the context of rigorous research.", "effective_date": "2020-08-11", "effective_date_note": "The who.int page date, 11 August 2020 (2020-08-11), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2020-08-13. Both dates are kept.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-who-2020-nonsevere-htn" }, { "type": "recommendation", "id": "maternal:rec-who-2022-a1b", "direction": "for", "intervention_id": "maternal:immediate-kmc", "context_id": "maternal:ctx-who-preterm-or-lbw-infants", "guideline_snapshot_id": "maternal:who-9789240058262-pdf-2026-10-09", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guidance intended to inform national and subnational policy, per the WHO publication page)", "strength_label": "Strong recommendation", "strength_system": "WHO guideline method with GRADE. Box 2.1 (PDF p. 22, printed p. 9) defines a strong recommendation, a conditional recommendation and a good practice statement, with certainty rated high, moderate, low or very low.", "effective_date": "2022-11-15", "effective_date_note": "The who.int page date, 15 November 2022 (2022-11-15), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2022-10-21. Both dates are kept.", "superseded_by": null, "supersession_status": "not_checked", "claim_id": "maternal:claim-who-a1b-immediate-kmc" }, { "type": "recommendation", "id": "maternal:rec-who-2022-acs-1-0", "direction": "for", "intervention_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-women-24w0d-34w0d", "guideline_snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global. WHO guidance for national and local protocols and policies; not a regulatory authorization.", "strength_label": "Context-specific recommendation", "strength_system": "WHO guideline method with GRADE and evidence-to-decision frameworks. The guideline sorts its recommendations into four categories: recommended; not recommended; recommended only in specific contexts (context-specific recommendation); and recommended only in the context of rigorous research. These are not GRADE strong or conditional labels. WHO rates certainty for each outcome with GRADE and gives no single certainty rating for a recommendation.", "effective_date": "2022-09-29", "effective_date_note": "The who.int page date, 29 September 2022 (2022-09-29), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2022-09-23. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2022-acs-1-0" }, { "type": "recommendation", "id": "maternal:rec-who-2022-acs-1-4", "direction": "against", "intervention_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-chorioamnionitis", "guideline_snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global. WHO guidance for national and local protocols and policies; not a regulatory authorization.", "strength_label": "Not recommended", "strength_system": "WHO guideline method with GRADE and evidence-to-decision frameworks. The guideline sorts its recommendations into four categories: recommended; not recommended; recommended only in specific contexts (context-specific recommendation); and recommended only in the context of rigorous research. These are not GRADE strong or conditional labels. WHO rates certainty for each outcome with GRADE and gives no single certainty rating for a recommendation.", "effective_date": "2022-09-29", "effective_date_note": "The who.int page date, 29 September 2022 (2022-09-29), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2022-09-23. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2022-acs-1-4-chorioamnionitis" }, { "type": "recommendation", "id": "maternal:rec-who-2022-acs-1-5", "direction": "against", "intervention_id": "maternal:antenatal-corticosteroids", "context_id": "maternal:ctx-who-2022-acs-planned-caesarean-34w0d-36w6d", "guideline_snapshot_id": "maternal:who-9789240057296-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global. WHO guidance for national and local protocols and policies; not a regulatory authorization.", "strength_label": "Not recommended", "strength_system": "WHO guideline method with GRADE and evidence-to-decision frameworks. The guideline sorts its recommendations into four categories: recommended; not recommended; recommended only in specific contexts (context-specific recommendation); and recommended only in the context of rigorous research. These are not GRADE strong or conditional labels. WHO rates certainty for each outcome with GRADE and gives no single certainty rating for a recommendation.", "effective_date": "2022-09-29", "effective_date_note": "The who.int page date, 29 September 2022 (2022-09-29), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2022-09-23. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2022-acs-1-5-planned-caesarean" }, { "type": "recommendation", "id": "maternal:rec-who-2025-pph-21", "direction": "for", "intervention_id": "maternal:objective-blood-loss-measurement", "context_id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "guideline_snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.", "strength_label": "Recommended", "strength_system": "WHO 2025 consolidated PPH guideline. Each recommendation falls in one of four categories (Recommended, Not recommended, Recommended only in specific contexts, Recommended only in the context of rigorous research) and carries a development status (New, Updated, Revalidated or Edited). These are not GRADE strength labels. Recommendation 21 is Revalidated.", "effective_date": "2025-10-05", "effective_date_note": "The who.int page date, 5 October 2025 (2025-10-05), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2025-09-26. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2025-pph-21-objective-measurement" }, { "type": "recommendation", "id": "maternal:rec-who-2025-pph-22", "direction": "for", "intervention_id": "maternal:objective-blood-loss-measurement", "context_id": "maternal:ctx-who-2025-pph-all-women-giving-birth", "guideline_snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.", "strength_label": "Recommended", "strength_system": "WHO 2025 consolidated PPH guideline. Each recommendation falls in one of four categories (Recommended, Not recommended, Recommended only in specific contexts, Recommended only in the context of rigorous research) and carries a development status (New, Updated, Revalidated or Edited). These are not GRADE strength labels. Recommendation 22 is New.", "effective_date": "2025-10-05", "effective_date_note": "The who.int page date, 5 October 2025 (2025-10-05), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2025-09-26. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2025-pph-22-diagnostic-criteria" }, { "type": "recommendation", "id": "maternal:rec-who-2025-pph-27", "direction": "for", "intervention_id": "maternal:tranexamic-acid-pph-treatment", "context_id": "maternal:ctx-who-2025-pph-women-with-pph", "guideline_snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.", "strength_label": "Recommended", "strength_system": "WHO 2025 consolidated PPH guideline. Each recommendation falls in one of four categories (Recommended, Not recommended, Recommended only in specific contexts, Recommended only in the context of rigorous research) and carries a development status (New, Updated, Revalidated or Edited). These are not GRADE strength labels. Recommendation 27 is Edited.", "effective_date": "2025-10-05", "effective_date_note": "The who.int page date, 5 October 2025 (2025-10-05), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2025-09-26. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2025-pph-27-txa" }, { "type": "recommendation", "id": "maternal:rec-who-2025-pph-29", "direction": "for", "intervention_id": "maternal:pph-detection-and-first-response-bundle", "context_id": "maternal:ctx-who-2025-pph-vaginal-birth", "guideline_snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "issuer_id": "maternal:who", "jurisdiction": "Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.", "strength_label": "Recommended", "strength_system": "WHO 2025 consolidated PPH guideline. Each recommendation falls in one of four categories (Recommended, Not recommended, Recommended only in specific contexts, Recommended only in the context of rigorous research) and carries a development status (New, Updated, Revalidated or Edited). These are not GRADE strength labels. Recommendation 29 is Revalidated.", "effective_date": "2025-10-05", "effective_date_note": "The who.int page date, 5 October 2025 (2025-10-05), is the effective date under the atlas rule for WHO decisions. The WHO IRIS record lists an issue date of 2025-09-26. Both dates are kept.", "superseded_by": null, "supersession_status": null, "claim_id": "maternal:claim-who-2025-pph-29-bundle" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k241453", "product_id": "maternal:elecsys-sflt1-plgf", "product_version": "Elecsys sFlt-1 and Elecsys PlGF, for cobas e analyzers, as cleared under K241453", "indication": "An aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks who are hospitalized for a hypertensive disorder of pregnancy, to develop pre-eclampsia with severe features within two weeks from testing, used in conjunction with clinical assessment and routine laboratory testing. The regulation for the device type says it is not intended for diagnosis of any disease.", "context_id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "jurisdiction": "United States", "authority_id": "core:fda", "decision_type": "clearance", "submission_id": "K241453", "pathway": "510k", "product_code": "QWH", "device_class": "II", "decision_date": "2025-02-07", "valid_to": null, "claim_id": "maternal:claim-fda-k241453-indication" } ], "reviews": [], "reviewers": [] }, "content_digests": { "core:blood-pressure": "8a61b189915978dbb45ce98eab06f73f1d7d00ef4f83a082c9b5634b4cf35269", "core:hypertension": "1194968cea3589ede533ccb04e82f6a6da849a7b5f447e342cf92327278d5ad1", "core:home-bp-monitoring": "e85587c581b32965037b172632566416bfbe9acc09d8eca26e52ba12b1b49ed6", "core:lancet": "3df1a8f1efa2da7c4e0e001cbc03da8f1414614af21cfa59ed00ffb1cfac6ff4", "core:nejm": "cbe467d311fdfb1f4ee32a254cd4be84e31ddda89455c106aada442b725e24d9", "core:fda": 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