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A new formulation of carbetocin could be safe and effective to prevent excessive bleeding after childbirth and save thousands of lives, according to the results of a clinical trial of the World Health Organization. Health (WHO) in 10 countries, including South Africa.
Currently, the WHO recommends oxytocin as the first choice drug to prevent excessive bleeding after childbirth.
However, oxytocin must be stored and transported between 2 and 8 degrees Celsius, which is difficult to do in many countries, depriving many women of access to this drug that can save them life. If exposed to heat, the drug becomes less effective.
The study, published in the New England Journal of Medicine, shows that a thermostable formulation of carbetocin can be as safe as oxytocin to prevent postpartum hemorrhages.
This new formulation of carbetocin does not require refrigeration and retains its effectiveness for at least 3 years 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," said Tedros Adhanom Ghebreyesus, WHO Director General
About 70,000 women die each year due to postpartum. For the trial, the team studied nearly 30,000 women who gave birth badlly in 10 countries: India, Argentina, Egypt, Kenya, Nigeria, Singapore, South. Africa, Thailand, Uganda and the United Kingdom.
Each woman randomly received a single injection of carbetocin or thermostable oxytocin immediately after the birth of her baby.
The study found that both drugs were equally effective at preventing excessive bleeding after birth, but oxytocin tends to degrade at higher temperatures, while thermostable carbetocin n & # 39; 39, had no effect of high temperature
. in the prevention of postpartum hemorrhage and these findings pave the way for thermostable carbetocin to potentially save the lives of thousands of women, particularly in areas where cold chain transport and storage are not available. not feasible, "said Professor Klaus Dugi. Pharmaceuticals, a company based in Switzerland that developed the drug
The next step is the regulatory review and approval by countries, said the WHO.
– IANS
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