A new alternative drug has been developed that may save lives of thousands of women in low- and lower-middle-income countries who die due to excessive bleeding following vaginal childbirth. A study led by the World Health Organization (WHO) in collaboration with MSD for Mothers and Ferring Pharmaceuticals has found that the new formulation of the drug can prevent Postpartum haemorrhage.
The clinical trial for the study was the largest of its kind, conducted in India and nine other countries across the world.
At present, WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. Oxytocin, however, needs to be stored and transported in at 2–8 degrees Celsius – something that is difficult to ensure in many countries. This lifesaving drug reaches many women in less effective state because of exposure to heat.
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Carbetocin, the new drug, is heat-stable and has been found to be as safe and effective as Oxytocin when it comes to preventing postpartum haemorrhage, according to the study published earlier this week in the New England Journal of Medicine. WHO says this new formulation does not require refrigeration, and retains its efficacy for at least three years stored at 30 degrees Celsius and 75% relative humidity.
“This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive,” says Dr Tedros Adhanom Ghebreyesus, Director-General of WHO.
Every year, approximately 70 000 women die because of post-partum haemorrhage, the most common cause of maternal death that also increases the mortality risk for the babies.
The clinical trial, the largest of its kind, studied close to 30000 women who gave vaginal birth in 10 countries — Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.
Each woman was randomly given a single injection of either heat-stable Carbetocin or Oxytocin immediately following the birth of her baby. The study found that both drugs were equally effective at preventing excessive bleeding after birth.
The WHO however says, “Since both drugs in the study were kept in at the temperatures required to ensure maximum efficacy of Oxytocin, the trial may underestimate the benefit expected with heat-stable carbetocin use in real-life settings where Oxytocin may have degraded due to exposure to higher temperatures.”
This WHO study, also referred to as the CHAMPION (Carbetocin HAeMorrhage PreventION) trial, was funded by MSD for Mothers and conducted under a collaborative arrangement between WHO, MSD for Mothers and Ferring Pharmaceuticals, which provided the Carbetocin stock for the study.
With the trial giving positive results, the parties will now work to advance affordable access to the drug in countries with a high burden of maternal deaths.
“The development of a drug to prevent postpartum haemorrhage that continues to remain effective in hot and humid conditions is very good news for the millions of women who give birth in parts of the world without access to reliable refrigeration,” says Dr Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO.
The next step to make the drug reach the target group is regulatory review and approval by countries.
WHO says it will ask its Guideline Development Group to consider whether heat-stable Carbetocin should be a recommended drug for the prevention of postpartum haemorrhage.