{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:carbetocin", "owner": "maternal", "kind": "drug", "slug": "carbetocin", "name": "Carbetocin (heat-stable formulation)", "aliases": [ "Heat-stable carbetocin" ], "atlases": [ "maternal" ], "summary_plain": "Carbetocin is a uterotonic, like oxytocin: a medicine that makes the womb contract. It is given as an injection right after birth to prevent heavy bleeding. The heat-stable form does not need a fridge, which matters where it is hard to keep medicines cold. WHO recommends carbetocin for preventing bleeding after birth, and recommends the heat-stable form where oxytocin cannot be kept cold. WHO does not recommend it for starting labour or for treating bleeding.", "summary_technical": "Drug, level substance. The CHAMPION trial (NEJM 2018, 29,645 women, WHO multi-country) compared 100 micrograms of intramuscular heat-stable carbetocin with 10 IU of oxytocin after vaginal birth. WHO 2025 Recommendation 7.2 recommends carbetocin for all births and Recommendation 11 recommends the heat-stable form where the oxytocin cold chain cannot be maintained; the heat-stable form differs from the non-heat-stable one only in its excipients. WHO says carbetocin is not currently recommended for other obstetric indications. Identity: an RxNav name search for carbetocin on 2026-10-14 returned no concept, and an openFDA drugsfda search for carbetocin returned no match (fetch-log label mg-openfda-drugsfda-carbetocin.json, HTTP 404); these show only what those two searches returned, and they are not statements about regulatory status elsewhere. No US regulatory decision is recorded.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ], "care-area": [ "postpartum-recovery" ] } }, "payload": { "level": "substance", "mechanism": null }, "content_digest": "3a7225325a550e3119fc047100535a9ac5a7223f5a3776f74ecabcae166114ea", "review": { "content_digest": "3a7225325a550e3119fc047100535a9ac5a7223f5a3776f74ecabcae166114ea", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-champion-1000ml", "owner": "maternal", "subject_entity_id": "maternal:carbetocin", "category": "effect", "statement": "The second primary outcome of CHAMPION, blood loss of at least 1000 mL, occurred in 1.51% of the heat-stable carbetocin group and 1.45% of the oxytocin group (relative risk 1.04, 95% confidence interval 0.87 to 1.25). The confidence interval crossed the margin of noninferiority (1.23), so noninferiority was not shown for this outcome. The authors say the low event rates for this outcome reduced the power of the trial.", "context": { "id": "maternal:ctx-champion-women-vaginal-birth", "label": "Women giving birth vaginally across 23 sites in 10 countries, CHAMPION (carbetocin or oxytocin immediately after birth)", "recipient": "maternal", "population": "Women who gave birth vaginally and were randomised to an intramuscular injection of heat-stable carbetocin 100 micrograms or oxytocin 10 IU, given immediately after the birth. Both drugs were kept in cold storage (2 to 8 degrees Celsius) to maintain double-blinding. 29,645 women underwent randomisation.", "care_setting": "23 sites in 10 countries; the abstract does not say what kind of site took part", "geography": "10 countries; the abstract does not name them", "life_stage_note": "Childbirth, immediately after vaginal birth", "life_stage_terms": null, "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": "The abstract does not give the follow-up time.", "eligibility": { "inclusion": [ "Women giving birth vaginally in the CHAMPION trial" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is an inconclusive result as reported: noninferiority was not shown, and the authors say the low event rates reduced the power of the trial. The abstract gives percentages but no event counts, so none are computed. Both drugs were kept in cold storage to keep the trial double-blind. The 500 mL result is a separate claim.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentences 3 and 4: second primary outcome and margins", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-29949473-2026-10-14", "retrieved_at": "2026-10-14T18:18:27Z", "content_hash": "37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa1805489", "source_type": "publication", "title": "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth", "canonical_url": "https://doi.org/10.1056/NEJMoa1805489", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1805489", "normalized_value": "10.1056/nejmoa1805489", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "29949473", "normalized_value": "29949473", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-08-23", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 3: blood loss of at least 1000 mL", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-29949473-2026-10-14", "retrieved_at": "2026-10-14T18:18:27Z", "content_hash": "37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa1805489", "source_type": "publication", "title": "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth", "canonical_url": "https://doi.org/10.1056/NEJMoa1805489", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1805489", "normalized_value": "10.1056/nejmoa1805489", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "29949473", "normalized_value": "29949473", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-08-23", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Abstract, CONCLUSIONS, sentence 2: noninferiority not shown", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-29949473-2026-10-14", "retrieved_at": "2026-10-14T18:18:27Z", "content_hash": "37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa1805489", "source_type": "publication", "title": "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth", "canonical_url": "https://doi.org/10.1056/NEJMoa1805489", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1805489", "normalized_value": "10.1056/nejmoa1805489", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "29949473", "normalized_value": "29949473", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-08-23", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.", "public_text": "quote" } } ], "review": { "content_digest": "723316b4a51677333dc56093c609a0b0d7a656dcba0886407d89ae0ec0515f74", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-champion-1000ml.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-champion-500ml", "owner": "maternal", "subject_entity_id": "maternal:carbetocin", "category": "effect", "statement": "CHAMPION randomised women after vaginal birth, in a double-blind noninferiority trial, to intramuscular heat-stable carbetocin 100 micrograms or oxytocin 10 IU. The first primary outcome, blood loss of at least 500 mL or the use of additional uterotonic agents, occurred in 14.5% of the carbetocin group and 14.4% of the oxytocin group (relative risk 1.01 with a 95% confidence interval of 0.95 to 1.06), a finding consistent with noninferiority (margin 1.16). The use of additional uterotonic agents, interventions to stop bleeding and adverse effects did not differ significantly between the two groups.", "context": { "id": "maternal:ctx-champion-women-vaginal-birth", "label": "Women giving birth vaginally across 23 sites in 10 countries, CHAMPION (carbetocin or oxytocin immediately after birth)", "recipient": "maternal", "population": "Women who gave birth vaginally and were randomised to an intramuscular injection of heat-stable carbetocin 100 micrograms or oxytocin 10 IU, given immediately after the birth. Both drugs were kept in cold storage (2 to 8 degrees Celsius) to maintain double-blinding. 29,645 women underwent randomisation.", "care_setting": "23 sites in 10 countries; the abstract does not say what kind of site took part", "geography": "10 countries; the abstract does not name them", "life_stage_note": "Childbirth, immediately after vaginal birth", "life_stage_terms": null, "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": "The abstract does not give the follow-up time.", "eligibility": { "inclusion": [ "Women giving birth vaginally in the CHAMPION trial" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Both drugs were kept in cold storage (2 to 8 degrees Celsius) to keep the trial double-blind, so the trial did not test the heat-stable property itself. A noninferiority result means carbetocin was not worse than oxytocin by the stated margin; it is not a finding that carbetocin is better. The outcome combines two things, blood loss of at least 500 mL or additional uterotonics. The trial was funded by Merck Sharpe & Dohme as the abstract spells it (organisation record not created in this atlas). The abstract was read; the full text was not. The registry numbers are named in the PubMed record and were not fetched.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS: design, doses and primary outcomes", "applicability_note": "PubMed abstract; the full text was not retrieved.", "snapshot": { "id": "maternal:pubmed-29949473-2026-10-14", "retrieved_at": "2026-10-14T18:18:27Z", "content_hash": "37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa1805489", "source_type": "publication", "title": "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth", "canonical_url": "https://doi.org/10.1056/NEJMoa1805489", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1805489", "normalized_value": "10.1056/nejmoa1805489", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "29949473", "normalized_value": "29949473", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2018-08-23", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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The full text and the version of record were not fetched.", "reuse_basis": "PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). 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The recommendation applies to women giving birth vaginally or by caesarean section. WHO says it applies only to carbetocin for preventing bleeding: carbetocin is not currently recommended for other obstetric indications, such as labour induction, labour augmentation or treatment of postpartum haemorrhage. WHO notes that the heat-stable formulation differs from the non-heat-stable one only in its excipients and not in the active ingredient.", "context": { "id": "maternal:ctx-who-2025-pph-oxytocin-cold-chain-not-maintained", "label": "Births in settings where the oxytocin cold chain cannot be consistently maintained (WHO 2025 Recommendation 11)", "recipient": "maternal", "population": "Women giving birth vaginally or by caesarean section in settings where continuous refrigeration (typically 2 to 8 degrees Celsius) of oxytocin during storage, transport and handling cannot be reliably ensured, for example because of infrastructure limits, unstable electricity or lack of temperature monitoring. WHO says many low- and middle-income countries, particularly rural and remote areas, fall in this category.", "care_setting": "Not stated in the source", "geography": "Global (WHO guidance intended to inform national and subnational policy).", "life_stage_note": "Childbirth, third stage of labour", "life_stage_terms": null, "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": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Women giving birth where the oxytocin cold chain cannot be consistently maintained" ], "exclusion": [] } }, "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "WHO 2025 categories are not GRADE strength labels, so the claim certainty is left not assessed. The evidence base (WHO web annex) was not read. WHO also recommends carbetocin for all births in Recommendation 7.2 (any formulation is recommended there, with the heat-stable form where the cold chain cannot be guaranteed); this claim records only Recommendation 11. The CHAMPION trial of heat-stable carbetocin against oxytocin is a separate claim.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Summary list of recommendations, Recommendation 11 and section 3 text and category", "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", "retrieved_at": "2026-10-11T19:12:00Z", "content_hash": "2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "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", "identifiers": [ { "scheme": "isbn", "value": "978-92-4-011563-7", "normalized_value": "9789240115637", "match": "exact", "version": null, "label": null, "from_source": false } ], "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" } }, { "evidence_role": "supports", "locator": "Recommendation 11, Remarks: scope, cold-chain definition, indications not recommended; Recommendation 7.2 Remarks: excipients", "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", "retrieved_at": "2026-10-11T19:12:00Z", "content_hash": "2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "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", "identifiers": [ { "scheme": "isbn", "value": "978-92-4-011563-7", "normalized_value": "9789240115637", "match": "exact", "version": null, "label": null, "from_source": false } ], "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" } } ], "review": { "content_digest": "1fd167ac636d3fb1b6af50649bffc97dbeb9f7645818b7f28746f8cf590e74f4", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-heat-stable-carbetocin-who-2025.json" } ], "decisions": [ { "type": "recommendation", "id": "maternal:rec-who-2025-heat-stable-carbetocin", "direction": "for", "intervention_id": "maternal:carbetocin", "context_id": "maternal:ctx-who-2025-pph-oxytocin-cold-chain-not-maintained", "guideline_snapshot_id": "maternal:who-9789240115637-pdf-2026-10-11", "guideline_id": "maternal:pub-who-2025-pph", "issuer_id": "maternal:who", "jurisdictions": [ "GLOBAL" ], "jurisdiction_note": "Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.", "strength_label": "Context-specific recommendation", "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 11 is Updated. The guideline prints its category as Context-specific recommendation, which is its short name for Recommended only in specific contexts.", "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-heat-stable-carbetocin-who-2025" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "evaluated_for", "label": "CHAMPION: heat-stable carbetocin against oxytocin for blood loss of at least 500 mL or additional uterotonics, non-inferiority shown", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "maternal:postpartum-hemorrhage", "other_entity_in_atlas": true, "claim_id": "maternal:claim-champion-500ml", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "evaluated_for", "label": "CHAMPION: heat-stable carbetocin against oxytocin for blood loss of at least 1000 mL, non-inferiority not shown", "clinical_claim_not_fact": true, "family": "clinical", "other_entity_id": "maternal:postpartum-hemorrhage", "other_entity_in_atlas": true, "claim_id": "maternal:claim-champion-1000ml", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "related_to", "label": "One uterotonic option for the prevention step", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:uterotonic-pph-prevention", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:front-medicines-and-vaccines", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [ { "predicate": "investigates", "label": "Investigated in", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:champion-trial", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:pubmed-29949473-2026-10-14", "locator": "Abstract, BACKGROUND, sentence 3, and METHODS, sentence 1" }, "primary": false, "role": null, "valid_from": null, "valid_to": null } ] }, "page_path": "drugs/carbetocin/", "context_path": "api/v1/context/maternal--carbetocin.md" }