The deaths of thousands of women from bleeding after childbirth could be prevented by a new drug which does not need to be stored in a refrigerator, according to research conducted in collaboration with the University of Birmingham.
Led by the World Health Organisation (WHO), the study found the ‘heat stable’ drug, called carbetocin, is as effective at preventing haemorrhaging as oxytocin – the medication which is the first choice treatment in countries such as the UK.
In the UK, women receive an injection of oxytocin after birth which helps promote contractions of the womb and stop excessive bleeding.
It is now hoped that the use of carbetocin for women living in hot climates could reduce the 70,000 deaths around the world each year caused by postpartum haemorrhage (PPH) – the leading cause of maternal death.
Oxytocin, the current standard, needs to be stored below 8C or it becomes ineffective and this means it is unsuitable in many low and middle income countries where 99 per cent of PPH deaths occur. Carbetocin, on the other hand, can survive for three years at 30 degrees and for over six months at 41 degrees.
Professor Arri Coomarasamy, of the University of Birmingham’s Institute of Metabolism and Systems Research, who led the UK arm of the trial, said: “We were thrilled to be part of trialling a medicine which has been found to have the potential to save the lives of thousands of women giving birth.
“Refrigeration is readily available in the UK but many countries don’t have facilities to keep medicines cold, reducing their effectiveness.
“This trial showed that heat-stable carbetocin is as effective in preventing childbirth related haemorrhage as the current standard of care stored under optimal conditions, and has the added benefit of not requiring refrigeration.”
Dr Girija Mohanty a doctor at one of the trial sites in Cuttack, India, said: “Every day I see first-hand the devastating effects PPH can have on a mother and her family here in India.
“It’s extremely frustrating to know that much of this suffering could be prevented if only we could reliably distribute and store medicines in a refrigerator.”
He said keeping medicines between 2C and 8C can be “impossible” at remote hospitals and clinics, but “even before medicines reach us they risk exposure to very high temperatures on long road journeys”.
PPH affects 14 million women a year, and children who lose their mothers are also much less likely to survive infancy.
The WHO-led “Champion” trial recruited 30,000 women from 10 different countries, including UK, Uganda, Thailand and Egypt, to trial carbetocin.
To ensure that the findings were not subject to bias both drugs were kept in cold storage so neither doctors or patients knew which treatment was being given – known as double blinding.
The results of the study, published in The New England Journal of Medicine, found that blood loss of more than 500mls occurred in 14.5 per cent of the women given carbetocin, compared to 14.4 per cent of the oxytocin group.
While blood loss of more than 1,000ml occurred in 1.51 per cent of the carbetocin group, compared to 1.45 per cent of the women who received oxytocin.
Both results show carbetocin to be as effective as oxytocin and its performance would likely be much better than oxytocin in real-life conditions where reliable refrigeration is not available.
- The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
- Widmer et al (2018). ‘Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth’. The New England Journal of Medicine. DOI: 10.1056/NEJMoa1805489
- The trial was funded by MSD for Mothers, a division of the drug company Merck, and carbetocin was provided by Ferring Pharmaceuticals, which developed the drug.