A study from the World Health Organisation (WHO), in collaboration with MSD for Mothers and Ferring Pharmaceuticals, has revealed that a new formulation of a drug that prevents excessive bleeding in women following childbirth could save thousands of women’s lives in low and lower-middle income countries.
Birth
Oxytocin, which is recommended by WHO as the first-choice drug to prevent excessive bleeding post-childbirth, currently needs to be kept at a temperature between 2–8°C. In many countries, maintaining this temperature for storage and transportation of the drug proves difficult and means that women are deprived of access to the lifesaving treatment.
In the study, published in the New England Journal of Medicine, a new formulation of carbetocin that is heat-stable was shown to be safe and effective as oxytocin in preventing postpartum haemorrhage. This new formulation does not require refrigeration and retains its efficacy for at least three years stored at 30°C and 75% relative humidity.
“This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive,” stated Dr Tedros Adhanom Ghebreyesus, director-general of WHO.
It is estimated that 70,000 women die every year from postpartum haemorrhage, which also has a knock-on effect in increasing the number of babies that die within one month of being born.
Nearly 30,000 women who had given birth vaginally in 10 countries (Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK) were included in the clinical trial. Each woman was randomly administered with a single. Injection of either heat-stable carbetocin or oxytocin immediately after giving birth. The findings revealed that both drugs were equally effective at preventing excessive bleeding after birth.
However, in the study both drugs were kept at the temperature range required to ensure maximum efficiency of oxytocin and therefore, the benefits of carbetocin may be underestimated compared with real-life settings.
“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,” explained Dr Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO.
Next steps include regulatory review and approval in the various countries and WHO will also ask its Guideline Development Group whether heat-stable carbetocin should be a recommended drug for the prevention of postpartum haemorrhage.