A large randomized trial conducted by the World Health Organization (WHO) has found that heat-stable carbetocin is as safe and effective as oxytocin in preventing postpartum hemorrhage (PPH)—excessive bleeding after childbirth and one of the leading causes of global maternal deaths. This is a critical finding given that oxytocin, the current standard therapy for preventing PPH, requires storage and transport conditions that are often not accessible in low-resource settings. The new formula of carbetocin used in the study does not require refrigeration and lasts for at least three years when stored at higher, more humid temperatures.
Researchers randomized nearly 30,000 women from 23 sites in Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom to receive a muscular injection of either heat-stable carbetocin or oxytocin immediately after vaginal delivery. They then measured the proportion of women with blood loss of at least 500 milliliters or the use of additional uterotonic agents as well as the proportion of women with blood loss of at least 1000 milliliters at one hour and up to two hours after birth for women who continued to bleed after one hour. Results indicated no significant differences in blood loss among women who had received the heat-stable carbetocin compared to those who had received oxytocin.
The researchers noted that since both oxytocin and carbetocin were maintained in low temperatures needed to ensure oxytocin’s efficacy, the results may underestimate the benefits of heat-stable carbetocin in real-life settings where higher temperatures may compromise the quality of oxytocin.
According to leaders at WHO:
“This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive.”
—Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO
“The development of a drug to prevent postpartum haemorrhage that continues to remain effective in hot and humid conditions is very good news for the millions of women who give birth in parts of the world without access to reliable refrigeration.”
—Dr. Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO
These findings represent a critical development in preventing the most common direct cause of maternal death around the world, with next steps including regulatory review and approval by countries. WHO’s Guideline Development Group will be considering whether to include heat-stable carbetocin as a recommended drug for PPH prevention.
What else is needed to ensure that no woman dies from postpartum hemorrhage, a preventable cause of maternal death? We’d love to hear from you!