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whoCREP1 A phase III, randomized, double-blind, active, controlled, multinational, multicentre,  non-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally  
THE WHO CHAMPION TRIAL - Trial registry:  ACTRN12614000870651 

 

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Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain cold-chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality.

The World Health Organization, Merck for Mothers and Ferring Pharmaceuticals discussed room temperature stable carbetocin (carbetocin RTS) as a promising intervention for reducing PPH, and agreed to proceed with a randomized, double-blind, non-inferiority trial to evaluate the effectiveness of carbetocin RTS compared to oxytocin for the prevention of PPH after vaginal birth.

 

Approximately 30,000 women delivering vaginally will be recruited across 22 centers in 10 countries.

The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint), and blood loss ≥1000 mL.

 

If the results of the study show that carbetocin RTS is a safe and effective alternative to oxytocin, this could have substantial impact on the prevention of PPH and maternal survival worldwide. Should that be the case, the WHO recommendations for the prevention and treatment of PPH will be updated accordingly, HRP/RHR will undertake the application to the WHO Model List of Essential Medicines and carbetocin RTS will be made available in high-burden countries at a public sector price comparable to oxytocin’s price.

CREP