The World Health Organization (WHO) said on Wednesday that a new formulation of drug preventing excessive bleeding following childbirth could save thousands of women's lives in low- and lower-middle-income countries.
Currently, the WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. However, the drug must be stored and transported at two to eight degrees Celsius, which is hard to do in many countries, thus depriving many women of access to this lifesaving drug. And when they can obtain it, the drug may be less effective because of heat exposure.
In a latest study published in the New England Journal of Medicine, the WHO has shown an alternative drug, heat-stable carbetocin, to be as safe and effective as oxytocin in preventing postpartum hemorrhage. This new formulation of carbetocin does not require refrigeration and retains its efficacy for at least three years when stored at 30 degrees Celsius and 75 percent relative humidity.
"This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive," says Tedros Adhanom Ghebreyesus, Director-General of the WHO.
According to WHO statistics, currently about 70,000 women die every year because of post-partum hemorrhage, which also increases the risk that their babies also die within one month.
The clinical trial of heat-stable carbetocin, the largest of its kind, studied close to 30,000 women who gave birth vaginally in 10 countries, including 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.
Since both drugs in the study were kept 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.
"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," says Metin Gulmezoglu, from the Department of Reproductive Health and Research at the WHO.
The UN health agency said it would consider whether heat-stable carbetocin should be a recommended drug for the prevention of postpartum hemorrhage.
