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CHAMPION trial (heat-stable carbetocin against oxytocin)

A large trial in 10 countries that compared a heat-stable form of carbetocin with oxytocin, each given by injection right after a vaginal birth, to prevent heavy bleeding. Heat-stable carbetocin was no worse than oxytocin for the first main outcome, blood loss of 500 mL or more or extra medicine to stop bleeding. For the second main outcome, blood loss of 1000 mL or more, noninferiority was not shown, and the authors say the low event rates reduced the power of the trial.

Also called CHAMPION

  • Study
  • In this atlas

Overview

Design
Randomised, double-blind, noninferiority trial comparing intramuscular heat-stable carbetocin 100 micrograms with intramuscular oxytocin 10 IU, given immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8 degrees Celsius) to maintain double-blinding.
Phase
Not reported
Enrolled
  • 29,645 women (randomized count) (Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • ANZCTR ACTRN12614000870651
  • EudraCT 2014-004445-26
  • CTRI CTRI/2016/05/006969
Started
Not reported
Primary completion
Not reported
Completion
Not reported
Countries
Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda, United Kingdom (CHAMPION: carbetocin versus oxytocin to prevent postpartum haemorrhage (ANZCTR record), retrieved )
Care setting
23 sites in 10 countries. The abstract does not say what kind of site took part or name the countries. (Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth, retrieved )
Registry status
Not reported

Technical summary

Randomised, double-blind, noninferiority trial (2018; PMID 29949473) at 23 sites in 10 countries; 29,645 women underwent randomisation. Registry numbers named in the PubMed record: ACTRN12614000870651 (ANZCTR), EudraCT 2014-004445-26 and CTRI/2016/05/006969; the registry records were not fetched, so no registry dates or status are recorded. Funded by Merck Sharpe & Dohme, as the abstract spells the name. The 2025 postpartum haemorrhage guideline calls it a multi-country trial of nearly 30 000 women. Both drugs were kept in cold storage to maintain double-blinding.

Arms

Findings

No findings are published for this study.

Record details

Record id
maternal:champion-trial
Content hash
59ffc83740a86793eec9a6e45e404da7fd8dabcd4431fa64dee317a1a50daec2