WHO to trial a new drug to stop women dying in childbirth
April 4, 2014 – The World Health Organization (WHO), Merck and Ferring Pharmaceuticals announce a partnership to evaluate a new, proprietary, room-temperature stable formulation of carbetocin—a drug for preventing postpartum haemorrhage after childbirth.
This trial is a new step for WHO. If the trial is successful, it could mean the difference between life and death for thousands of women.
Dr Marleen Temmerman, Director of HRP and WHO’s Department of Reproductive Health and Research.
Postpartum haemorrhage—heavy bleeding after childbirth—is the leading cause of maternal mortality in low-income countries. It causes nearly a quarter of all deaths from complications of pregnancy and childbirth in sub-Saharan Africa and Asia.
Since the mid-1990s, the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training (HRP) has conducted a number of large multicentre trials on the best ways to prevent and treat postpartum haemorrhage in more than ten countries. The results of these trials formed the basis for the current WHO recommendations to prevent and treat postpartum haemorrhage. One of these recommendations is that the drug oxytocin be used for the management of postpartum haemorrhage. It is recommended that oxytocin be stored in cold conditions, but this is difficult to achieve and maintain in many parts of the world.
Since 2011, Merck for Mothers, Ferring Pharmaceuticals and the World Health Organization have been discussing the potential of the room-temperature formulation of carbetocin (carbetocin RTS) as a promising intervention for reducing postpartum haemorrhage, particularly in the many areas of the world where oxytocin cold storage is difficult to achieve and maintain. The parties have now agreed to a formal collaboration in the development and future availability of carbetocin RTS. As part of this collaboration,WHO will conduct a multi-centre trial that will seek to show that carbetocin RTS, a drug that can be stored at room temperature, is as effective as oxytocin in the prevention of postpartum haemorrhage.
This randomized trial will be conducted independently by WHO and it will be conducted as part of the maternal and perinatal health research programme of HRP for the prevention and treatment of leading causes of maternal mortality. The study will start later this year in 12 countries around the world with participation from approximately 29 000 women. If the results of the study show that carbetocin RTS is as effective as oxytocin, WHO, Merck and Ferring will work together to make the drug available in developing countries where there is a high burden of deaths from postpartum haemorrhage at a price that is comparable to that of oxytocin and affordable to the public health sector. This would have major implications for expanding access to effective care and could have a substantial impact on maternal survival.