New formulation saves mums from bleeding to death

A new formulation of a drug to prevent excessive bleeding after childbirth could save thousands of women’s lives in low- and lower-middle-income countries, according to a study led by the World Health Organisation (WHO) in collaboration with MSD for Mothers, and Ferring Pharmaceuticals.

Currently oxytocin is used as the first-line drug for preventing excessive bleeding after childbirth.

However, it must be stored and transported at 2 to 8 degrees Celsius, which is hard to do in many countries, hence denying many women access to this lifesaving drug.

And when they can obtain it, the drug may be less effective due to heat exposure.

The study, published in the New England Journal of Medicine shows that the heat-stable carbetocin is a better alternative because it does not require refrigeration and retains its efficacy for at least three years if stored at 30 degrees Celsius and 75 per cent relative humidity.

The clinical trial involved close to 30,000 women who gave birth vaginally in 10 countries: Kenya, Argentina, Egypt, India, 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.

Both drugs were equally effective at preventing excessive bleeding after birth.

But because both drugs 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.

“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,” said Dr Metin Gülmezoglu, from the Department of Reproductive Health and Research at the WHO.

The next step is regulatory review and approval by countries and WHO will ask its Guideline Development Group to consider whether heat-stable carbetocin should be recommended for the prevention of postpartum haemorrhage.

Post-partum haemorrhage is the largest direct cause of maternal death, accounting for 661,000 deaths worldwide between 2003 and 2009. In Kenya, it is the leading cause of maternal mortality, accounting for 34 per cent of maternal deaths.

More than 70 per cent of these deaths occur due to uterine atony, which results from poor contraction of the uterus after childbirth.