The World Health Organisation ( WHO )in collaboration with Ferring and MSD for Mothers, has broken new ground that could help save the lives of thousands of women by preventing excessive bleeding after childbirth, otherwise called postpartum haemorrhage (PPH).
Every year, 14 million women are affected by PPH. Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide, causing approximately 70,000 deaths per year. It remains a major cause of maternal death in Nigeria.
Results from the largest study conducted in prevention of PPH with nearly 30,000 women, in Nigeria and nine other low and lower-middle income countries, by WHO were published on Wednesday in the New England Journal of Medicine (NEJM).
Titled ‘CHAMPION Clinical Trial’, the study obtained new data showing heat-stable carbetocin is as effective as oxytocin, the current standard of care, in preventing excessive bleeding following vaginal birth.
Researched and developed by Ferring as a solution to address unmet needs in women’s health, heat-stable carbetocin remains effective at high temperatures, an answer to the limitation of oxytocin which must be stored and transported at 2 – 8°C.
Studies in Nigeria and other developing countries have revealed degradation and loss of efficacy in oxytocin ampoules, which could be due to inadequate storage and distribution conditions, hence the need for the heat-stable carbetocin product.
Data show that heat-stable carbetocin maintains effectiveness for at least three years at 30°C and six months at 40°C and has the potential to save thousands of women’s lives in Nigeria and other low- and lower-middle income countries, where 99% of PPH-related deaths occur and where the refrigeration of medicines can be difficult to achieve and maintain.
The WHO publication concludes that the study should inform care in countries where cold-chain transport and storage of medicines is difficult to achieve and is a barrier to effective PPH prevention.
Read Also: WHO tags video game ‘mental disorder’
“This is an important step forwards in PPH prevention and these results pave the way for heat- stable carbetocin to potentially save the lives of thousands of women, especially in areas where cold-chain transport and storage is not feasible,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “We will now work with the WHO and MSD for mothers to make heat- stable carbetocin available in countries where it is needed most, protecting women and families around the world.”
The clinical study was conducted by the WHO Department of Reproductive Health and Research including the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), using Ferring’s heat-stable carbetocin, and funded by MSD for Mothers.
The Switzerland based pharmaceutical giant will now seek registrations and manufacture affordable heat-stable carbetocin and ensure it is available in the public sector of low- and lower-middle income countries that have a high burden of maternal mortality.
No comments:
Write comentários