A new formulation of a drug to prevent excessive bleeding following childbirth could save thousands of women’s lives in low- and lower-middle-income countries, according to a study.
The study led by the World Health Organization (WHO) in collaboration with MSD for Mothers and Ferring Pharmaceuticals recommended oxytocin as the first-line drug for preventing excessive bleeding after childbirth.
A release issued by the WHO demanded that Oxytocin should however be stored and transported at two to eight degrees Celsius.
It noted however that this was hard to do in many countries, depriving many women of access to the lifesaving drug and that when they could obtain it, the drug might be less effective because of heat exposure.
The study, published in the New England Journal of Medicine, copied to the Ghana News Agency, has shown an alternative drug – heat-stable carbetocin – to be as safe and effective as oxytocin in preventing postpartum haemorrhage.
This new formulation of carbetocin does not require refrigeration and retains its efficacy for at least three years stored at 30 degrees Celsius and 75 percent relative humidity.
Dr Tedros Adhanom Ghebreyesus, Director-General of WHO said, “This is a truly encouraging new development that can revolutionize our ability to keep mothers and babies alive”.
Approximately 70, 000 women died every year because of post-partum haemorrhage – increasing the risk that their babies also died within one month.
The clinical trial, the largest of its kind, studied close to 30,000 women who gave birth vaginally 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.
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.
Dr Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO, says “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.”
The next step is regulatory review and approval by countries.
WHO will ask its Guideline Development Group to consider whether heat-stable carbetocin should be a recommended drug for the prevention of postpartum haemorrhage.
Following the positive results from the trial, the parties will now work to advance affordable access to this lifesaving drug in countries that have a high burden of maternal deaths.
Ghana ended the 2017 year with a maternal mortality rate of 319 per 100,000 live births according to the Ghana Health Service.
Studies in 2015 have shown the ineffectiveness of the application of oxytocin in six regions by the Centre for Pharmaceutical Advancement and Training, which suggested stringent measures to reserve the trend.
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