{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:affirm-trial", "owner": "maternal", "kind": "study", "slug": "affirm-trial", "name": "AFFIRM trial (awareness of fetal movements)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A trial in 33 maternity hospitals in the UK and Ireland that tested a package to make pregnant women more aware of the need to report reduced baby movements quickly, and to standardise what staff do next. The package did not reduce stillbirths, and the authors say its benefit remains unproven.", "summary_technical": "Stepped wedge, cluster-randomised trial (Lancet 2018; ClinicalTrials.gov NCT01777022, lead sponsor University of Edinburgh). 33 hospitals were randomised to one of nine implementation dates; 409,175 pregnancies in the report (registry count 430,830). Stillbirth 4.40 per 1000 births in the control period and 4.06 in the intervention period, adjusted odds ratio 0.90 (95% CI 0.75 to 1.07). Funded by the Chief Scientist Office (Scottish Government), Tommy's and Sands (PubMed abstract). Only the abstract and the registry record were read.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "nct", "value": "NCT01777022", "normalized_value": "NCT01777022", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "pregnancy" ], "care-area": [ "fetal-development" ] } }, "payload": { "design": "Stepped wedge, cluster-randomised trial. Maternity hospitals were grouped and randomised to one of nine intervention implementation dates at 3-month intervals; each hospital had a control period from 1 January 2014, a washout period of 2 months and an intervention period to 31 December 2016. Treatment allocation was not concealed from women and caregivers. Intention-to-treat analysis of births by period.", "drug_phase": "not_applicable", "registry_statuses": [ { "status": "COMPLETED", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" } ], "start_date": { "date": "2014-01-01", "type": "actual", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" }, "primary_completion_date": { "date": "2016-12-31", "type": "actual", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" }, "completion_date": { "date": "2017-09-30", "type": "actual", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" }, "results_first_posted": null, "countries": [ { "code": "IE", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" }, { "code": "GB", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" } ], "care_setting": null, "stopped_early": null, "enrollment": [ { "count": 430830, "basis": "enrolled", "unit": "participants (registry enrollment, type ACTUAL; the registry gives no unit)", "snapshot": "maternal:ctgov-nct01777022-2026-10-14" }, { "count": 409175, "basis": "unknown", "unit": "pregnancies (data collected, report abstract)", "snapshot": "maternal:pubmed-30269876-2026-10-14" }, { "count": 33, "basis": "randomized", "unit": "hospitals (randomly assigned to an implementation date)", "snapshot": "maternal:pubmed-30269876-2026-10-14" } ], "arms": [ { "id": "maternal:affirm-trial-arm-control", "label": "Current treatment (control period)", "intervention": null, "description": "Current education and management protocols followed." }, { "id": "maternal:affirm-trial-arm-package", "label": "Reduced fetal movement care package (intervention period)", "intervention": null, "description": "A package of interventions to raise women's awareness of the need to report reduced fetal movements promptly, followed by a management plan for identifying and delivering the at-risk fetus." } ], "findings": [] }, "content_digest": "2b6169ebf9165a88d728848024ac6e6193d4d87024ab9327921720ad81539728", "review": { "content_digest": "2b6169ebf9165a88d728848024ac6e6193d4d87024ab9327921720ad81539728", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-affirm-stillbirth", "owner": "maternal", "subject_entity_id": "maternal:affirm-trial", "category": "effect", "statement": "AFFIRM was a stepped wedge, cluster-randomised trial in the UK and Ireland of a care package for reduced fetal movements: it raised women's awareness of the need to report reduced movements promptly and standardised management, including timely delivery. 33 maternity hospitals were randomly assigned to one of nine implementation dates at 3-month intervals. Data from 409,175 pregnancies between 1 January 2014 and 31 December 2016 were collected (157,692 deliveries in the control period, 23,623 in the washout period and 227,860 in the intervention period). Stillbirth incidence was 4.40 per 1000 births in the control period and 4.06 per 1000 births in the intervention period (adjusted odds ratio 0.90, 95% CI 0.75 to 1.07; p=0.23). The authors conclude that the care package did not reduce the risk of stillbirth and that the benefit of a policy promoting awareness of reduced fetal movements remains unproven.", "context": { "id": "maternal:ctx-affirm-births", "label": "Births in 33 UK and Irish maternity hospitals, 2014 to 2016 (AFFIRM)", "recipient": "fetal", "population": "Fetuses and babies in 409,175 pregnancies delivered in 33 maternity hospitals in the UK and Ireland. The care package was aimed at pregnant women and clinicians (awareness of reduced fetal movements and standardised management), but the outcome, stillbirth, is counted per birth.", "care_setting": "33 maternity hospitals, randomly assigned to one of nine implementation dates at 3-month intervals", "geography": "United Kingdom and Ireland", "life_stage_note": "Pregnancy and birth, 1 January 2014 to 31 December 2016; the correction to the report defines stillbirths in its table legend as at 22 weeks of gestation or later", "life_stage_terms": { "maternal": [ "pregnancy", "childbirth" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Stillbirth incidence per 1000 births in the control, washout and intervention periods", "eligibility": { "inclusion": [ "Births in participating maternity hospitals during the control and intervention periods" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Allocation was not concealed from women and caregivers, and the data were derived from observational maternity data. The confidence interval (0.75 to 1.07) includes both a reduction of about a quarter and a small increase, so a modest effect is neither shown nor excluded. The registry count (430,830) and the report count (409,175 pregnancies) are different figures and are not reconciled here. The linked correction (PMID 34338212) was read: it amends some perinatal mortality data in Table 2, clarifies the table legend to define stillbirths at 22 weeks or later, and says the reported primary outcome data, summary and conclusions are unaffected; the stillbirth rates quoted here are the primary outcome. 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