Results of a WHO study, published today in the New England Journal of Medicine demonstrate that Carbetocin – a new heat-stable formulation of a drug used to prevent postpartum haemorrhage (excessive bleeding following childbirth) is as effective as the currently recommended oxytocin, which requires refrigeration. Eliminating the need for refrigeration could help to save the lives of thousands of women living in countries and settings where it is difficult to store drugs in the right conditions.
About postpartum haemorrhage (PPH)
Every year about 14 million women around the world suffer from postpartum haemorrhage (PPH). This severe bleeding after birth is the largest direct cause of maternal deaths. Shockingly, 99% of the deaths from PPH occur in low- and middle-income countries compared with only 1% in high-income countries although recent studies are showing that it is increasingly an issue of concern for wealthier countries too. In addition to the suffering and loss of women’s lives, when women die in childbirth, their babies also face a much greater risk of dying within one month compared to babies whose mothers survive.
WHO recommendation
Currently WHO recommends an injection of the drug oxytocin to prevent and treat PPH. Oxytocin, however, requires special cool storage conditions to remain effective and is unstable at room temperature. The cold chain storage required to transport and store oxytocin is often unreliable in resource-constrained countries and in emergency settings.
New study
In order to address these two issues, a new formulation of a drug to prevent and treat postpartum haemorrhage was tested by WHO in collaboration with MSD for Mothers and Ferring Pharmaceuticals*. This study is the largest of its kind, and included close to 30 000 women who gave birth vaginally in 10 countries: Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom. The results, published today in the New England Journal of Medicine, showed that the alternative drug – heat-stable carbetocin – is as safe and effective as oxytocin in preventing postpartum haemorrhage. Additionally, the drug does not require refrigeration and retains its efficacy for at least 3 years stored at 30 degrees Celsius and 75% relative humidity.
“The development of a drug to prevent 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. It could prevent so many tragic and unnecessary deaths,” says Dr Metin Gülmezoglu, Department of Reproductive Health and Research at WHO.
For resource-constrained countries carbetocin, has the potential to save thousands of women’s lives and to contribute substantially to the reduction of global maternal mortality and the achievement of Sustainable Development Goal 3.1.
* The clinical trial, also referred to as the CHAMPION (Carbetocin HAeMorrhage PreventION) trial was funded by MSD for Mothers and uses heat-stable carbetocin, which was researched and developed by Ferring. Neither company had any influence on any of the trial documents or processes.