Ferring Pharmaceuticals and MSD have concluded the carbetocin haemorrhage prevention (CHAMPION) trial for heat-stable carbetocin to treat excessive bleeding after childbirth, known as postpartum haemorrhage (PPH).
The trial was conducted in the human reproduction programme (HRP) for the World Health Organisation.
It enrolled around 30,000 women across ten countries, comprising Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda, and the UK.
CHAMPION was primarily designed to compare the effectiveness and safety of carbetocin with the current standard of care, oxytocin, in the prevention of PPH after vaginal births.
It was funded by MSD under the company’s ‘MSD for Mothers’ initiative.
WHO Maternal and Perinatal Health technical officer Mariana Widmer said: “Despite progress towards the UN sustainable development goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH.
“Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth.
“If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”
Each year, 14 million mothers are estimated to be affected by PPH. Even if the mothers survive PPH, the disease can lead to the need for serious medical interventions, including surgical removal of the uterus, as well as blood transfusions to address severe anemia.
Ferring’s heat-stable carbetocin has the potential to address a significant limitation associated with oxytocin, which is required to be refrigerated in temperatures above 8°C during shipping and storage to prevent degradation.
Carbetocin could remain active for longer durations in hot and humid climates, and potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain, and where 99% of maternal deaths occur due to PPH.