The World Health Organization (WHO) has said that a new heat stable version of a drug Carbetocin can save lives of new mothers could “revolutionize” therapy. The results of the study looking at the effectiveness of the new version of the drug were published in the latest issue of the New England Journal of Medicine.
At present around 70,000 women die annually of life threatening bleeding after childbirth called postpartum bleeding or postpartum haemorrhage. After childbirth the placenta separates from the walls of the uterus and this leads to bleeding. In most women the bleeding can stop by itself as the blood vessels of the uterus contract. However among one in six women the bleeding may not stop on its own and can become life threatening.
To prevent this postpartum haemorrhage, a drug called oxytocin is currently widely used worldwide. The WHO recommends that all women giving birth vaginally should be given oxytocin to prevent bleeding. Oxytocin however, needs to be stored at temperatures between two and eight degrees. The drug is denatured if it is exposed to higher temperatures at any point between manufacture and use. This is difficult in countries that have inadequate and unreliable refrigeration and power supplies for cooling. A new heat-stable version of this drug is called carbetocin. This can remain stable for up to 1,000 days in heat. This would especially be a boon in countries with hot and humid climates.
The effectiveness and usefulness of this new preparation was studied by researchers in the Champion trial where nearly 30,000 women from 10 different countries across the world including Uganda, Egypt and Thailand. These women were randomly allocated into two groups – one group received heat stable carbetocin injections while the other received oxytocin injections right after they gave birth vaginally.
Results showed that in both cases, the drugs could effectively prevent excessive bleeding after birth. The advantage of carbetocin over oxytocin however was its stability in heat. In both study groups around 14.5 percent of the new mothers lost around half a litre of blood. Around 1.45 percent and 1.51 percent of women receiving oxytocin and carbetocin respectively lost over one litre of blood. The difference between the two groups was not statistically significant explained the researchers.
According to experts this could make childbirth safer for women in 90 countries across the world. According to WHO expert Dr Metin Gulmezoglu this is a “very good news for the millions of women who give birth in parts of the world without access to reliable refrigeration.” He said, “It will help to save many lives of mothers in lower income countries where most deaths occur.” WHO's director general Dr Tedros Adhanom Ghebreyesus in his statement said, “This is a truly encouraging new development that can revolutionise our ability to keep mothers and babies alive.” Professor Arri Coomarasamy from the University of Birmingham, who led the UK arm of the trial also said that he was thrilled to be a part of this trial that could save thousands of lives.
At present the heat stable version of the drug is being used only in clinical trials and is not yet available for sale. Manufacturers can expect approval of the new version of the drug by next year for wider clinical use. The clinical trial was conducted by WHO along with MSD for Mothers, a division of the drug company Merck and Ferring Pharmaceuticals (the drug makers). The next step would be to make the new heat stable version of the drug available and sustainable at cheaper and affordable prices say experts.
DOI: 10.1056/NEJMoa1805489 | Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth | Mariana Widmer, M.Sc., Gilda Piaggio, Ph.D., Thi M.H. Nguyen, Ph.D., Alfred Osoti, M.P.H., Olorunfemi O. Owa, M.D., Sujata Misra, M.D., Arri Coomarasamy, M.R.C.O.G., Hany Abdel-Aleem, M.D., Ashalata A. Mallapur, M.D., Zahida Qureshi, M.D., Pisake Lumbiganon, M.D., Archana B. Patel, Ph.D., et al., for the WHO CHAMPION Trial Group https://www.nejm.org/doi/full/10.1056/NEJMoa1805489?query=featured_home