The World Health Organization says a revamped drug that can withstand extreme heat and stay effective for 1,000 days would save thousands of mothers in low- and middle-income nations. Photo by
Sanjas/pixabay
June 28 (UPI) -- A revamped drug that can withstand extreme heat and stay effective for 1,000 days would save thousands of mothers after childbirth, according to a study by the World Health Organization.
The medicine, which is known as heat-stable carbetocin, helps prevent fatal bleeding after women give birth. A clinical study, the results of which were published Wednesday in the New England Journal of Medicine, tested the drug on 29,645 women who gave birth vaginally in 10 counties from 2015 to Jan. 30 of this year.
"This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive," Dr. Tedros Adhanom Ghebreyesus, WHO's director-general, said in a press release.
Approximately 70,000 women die yearly because of post-partum hemorrhage, which leads to increased risk their babies also will die within a month, WHO said.
To prevent excessive bleeding after childbirth, WHO recommends oxytocin. But it must be stored and transported at lower than 46 degrees Fahrenheit, which is not possible in many countries. Ninety-nine percent of postpartum hemorrhage deaths occur in low- and middle-income countries, according to WHO.
"The development of a drug to prevent postpartum hemorrhage 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," Dr. Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO, said.
With a new formulation, carbetocin does not need to be refrigerated and lasts for at least three years when stored at 86 degrees Fahrenheit and 75 percent relative humidity. For six months, it lasts at 104 degrees.
The CHAMPION study -- Carbetocin HAeMorrhage PreventION -- was conducted in Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and Great Britain.
Each woman was given a single injection of heat-stable carbetocin or oxytocin immediately after childbirth. Both drugs were equally effective at preventing excessive bleeding. After delivery, about 14.5 percent of women in both groups lost at least a half-liter of blood.
The study noted that because both drugs were kept in temperatures required to ensure maximum efficacy of oxytocin, the trial may underestimate the benefit expected with heat-stable carbetocin use in real-life settings.
The drug is being developed by Ferring Pharmaceuticals, headquartered in Switzerland. Merck for Mothers, a philanthropic initiative of the drug company Merck, approached WHO about developing the heat-stable drug. The organization is known as Merck Sharpe & Dohme outside the United States.
"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," Dr. Klaus Dugi, chief medical officer at Ferring, said in a press release. "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."