Carbetocin (heat-stable formulation)
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.
Also called Heat-stable carbetocin
- Drug
- In this atlas
Overview
Technical summary
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.
About this drug
- Level
- Substance
- Mechanism
- Not reported
Claims and evidence
Context 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
- Childbirth, third stage of labour
- Gestational age
- Not reported
- Postnatal age
- Not reported
- Follow-up
- Not applicable (recommendation context)
Eligibility: 1 inclusion criterion; exclusion criteria not stated
- Included
- Women giving birth where the oxytocin cold chain cannot be consistently maintained
- Excluded
- None stated
WHO 2025 recommends heat-stable carbetocin (100 micrograms by intramuscular or intravenous injection) as the recommended choice for preventing postpartum haemorrhage in settings where the oxytocin cold chain cannot be consistently maintained (Recommendation 11, category Context-specific recommendation, status Updated). If heat-stable carbetocin is not available, misoprostol (400 or 600 micrograms by mouth) can be used instead. 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.
Applies to Maternal- 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.
- Not stated in the source
- Global (WHO guidance intended to inform national and subnational policy).
- Childbirth, third stage of labour
- Gestational age Not reported
- Postnatal age Not reported
- Certainty method
- Not assessed
- 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.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (2)
-
Supports Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage
- Locator
- Summary list of recommendations, Recommendation 11 and section 3 text and category
- How it applies
- WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de- 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.
-
Supports Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage
- Locator
- Recommendation 11, Remarks: scope, cold-chain definition, indications not recommended; Recommendation 7.2 Remarks: excipients
- How it applies
- WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de- 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.
Context 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
- Childbirth, immediately after vaginal birth
- Gestational age
- Not reported
- Postnatal age
- Not reported
- Follow-up
- The abstract does not give the follow-up time.
Eligibility: 1 inclusion criterion; exclusion criteria not stated
- Included
- Women giving birth vaginally in the CHAMPION trial
- Excluded
- None stated
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.
Applies to Maternal- 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.
- 23 sites in 10 countries; the abstract does not say what kind of site took part
- 10 countries; the abstract does not name them
- Childbirth, immediately after vaginal birth
- Gestational age Not reported
- Postnatal age Not reported
- Certainty method
- Not assessed
- 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.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (3)
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, METHODS, sentences 3 and 4: second primary outcome and margins
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, RESULTS, sentence 3: blood loss of at least 1000 mL
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, CONCLUSIONS, sentence 2: noninferiority not shown
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
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.
Applies to Maternal- 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.
- 23 sites in 10 countries; the abstract does not say what kind of site took part
- 10 countries; the abstract does not name them
- Childbirth, immediately after vaginal birth
- Gestational age Not reported
- Postnatal age Not reported
- Certainty method
- Not assessed
- 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.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (4)
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, METHODS: design, doses and primary outcomes
- How it applies
- PubMed abstract; the full text was not retrieved.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, RESULTS, sentences 1, 2 and 4: first primary outcome and secondary comparisons
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
-
Supports Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, CONCLUSIONS, sentence 1: noninferiority
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
-
Background Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth
- Locator
- Abstract, CONCLUSIONS, sentence 3: funder and registry numbers
- How it applies
- PubMed abstract.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
37658b6d4ec1af7e6f3804a075f30603d1f0890bb36fe080e139bef2c598fdaf- 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.
Guidance
Recommended: Carbetocin (heat-stable formulation)
Applies to Maternal
- 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.
- Not stated in the source
- Global (WHO guidance intended to inform national and subnational policy).
- Childbirth, third stage of labour
- Gestational age Not reported
- Postnatal age Not reported
- Issued by
- World Health Organization
- Guideline
- Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage (WHO, FIGO and ICM, 2025); Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage, 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.
- Strength
- Context-specific recommendation
- Effective
- 2025-10-05
- Jurisdictions
- Global; note: Global (WHO guidance intended to inform national and subnational policy). Co-published with FIGO and ICM.
- Basis
- WHO 2025 recommends heat-stable carbetocin (100 micrograms by intramuscular or intravenous injection) as the recommended choice for preventing postpartum haemorrhage in settings where the oxytocin cold chain cannot be consistently maintained (Recommendation 11, category Context-specific recommendation, status Updated). If heat-stable carbetocin is not available, misoprostol (400 or 600 micrograms by mouth) can be used instead. 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.
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.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
-
Claim, not a settled fact CHAMPION: heat-stable carbetocin against oxytocin for blood loss of at least 500 mL or additional uterotonics, non-inferiority shown: Postpartum haemorrhage
Applies to Maternal- 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.
- 23 sites in 10 countries; the abstract does not say what kind of site took part
- 10 countries; the abstract does not name them
- Childbirth, immediately after vaginal birth
- Gestational age Not reported
- Postnatal age Not reported
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.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.
-
Claim, not a settled fact CHAMPION: heat-stable carbetocin against oxytocin for blood loss of at least 1000 mL, non-inferiority not shown: Postpartum haemorrhage
Applies to Maternal- 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.
- 23 sites in 10 countries; the abstract does not say what kind of site took part
- 10 countries; the abstract does not name them
- Childbirth, immediately after vaginal birth
- Gestational age Not reported
- Postnatal age Not reported
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.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.
Record details
- Record id
maternal:carbetocin- Content hash
3a7225325a550e3119fc047100535a9ac5a7223f5a3776f74ecabcae166114ea