On July 1, the Centre's plan to restrict the manufacture of oxytocin will come into effect. But an alternative to the drug, used extensively to prevent excessive bleeding in childbirth, is already in the making.
Results of a new WHO study published in the journal, New England Journal of Medicine, shows that carbetocin is as safe and effective as oxytocin in preventing postpartum haemorrhage (PPH).
PPH is a complication of delivery and the most common cause of maternal deaths, accounting for 35 per cent of all maternal deaths worldwide, and 30 per cent of maternal deaths in India.
It is commonly defined as a blood loss of 500 ml or more within 24 hours after birth, while severe PPH is defined as a blood loss of 1000 ml or more within the same timeframe, according to the WHO.
The new alternative could save the lives of thousands of women in low and lower- middle income countries, according to the study led by the WHO, in collaboration with the US-based MSD for Mothers and the Swiss pharmaceutical company, Ferring Pharmaceuticals.
Currently, the WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding post childbirth. Oxytocin, however, must be stored and transported at 2–8 degrees celsius, and the drug may lose its effectiveness because of exposure to heat.
The new formulation of carbetocin, however, does not require refrigeration and retains its efficacy for at least three years when stored at 30 degrees celsius and 75 per cent relative humidity, the WHO said in a press note.
According to the WHO, around 70, 000 women die each year because of post-partum haemorrhage, increasing the risk of their babies dying within one month.
The carbetocin study is based on the results of a clinical trial, the largest of its kind, that included around 30, 000 women who gave birth vaginally in 10 countries. These include Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.
Each woman was randomly given a single injection of either the “heat-stable carbetocin” or oxytocin, immediately following the baby's birth. The study found that both drugs were equally effective at preventing excessive bleeding after birth.
Since both drugs in the study were kept at 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 WHO said in its statement.
“The development of a drug to prevent postpartum haemorrhage that continues to remain effective in hot and humid conditions is very good news for millions of women who give birth in parts of the world without access to reliable refrigeration,” Dr Metin Gülmezoglu, Department of Reproductive Health and Research, WHO was quoted in the statement.
The next step is regulatory review and approval by countries, and the WHO will ask its Guideline Development Group to consider whether heat-stable carbetocin should be a recommended drug for the prevention of postpartum haemorrhage.