A drug that was originally developed for military use to prevent severe bleeding on the battlefield could help to save thousands of women from dying in childbirth around the world each year, a new study suggests.
The drug, called tranexamic acid (TXA), works by inhibiting the breakdown of blood clots and has been shown to be effective in treating postpartum haemorrhage (PPH), one of the leading causes of maternal death worldwide.
However, until now, TXA had to be delivered via intravenous (IV) drip, which is often impractical or unavailable in many low- and middle-income countries (LMICs) where most of the 70,000 yearly deaths from PPH occur.
A new study, led by researchers from the London School of Hygiene and Tropical Medicine (LSHTM), has found that TXA can also be injected safely and quickly into the muscle of pregnant women who are at risk of PPH, providing a potential alternative to IV administration.
The study, published in the British Journal of Obstetrics and Gynaecology on Thursday, involved 120 women who were due to give birth by caesarean section at two hospitals in Pakistan and one in Zambia between December 2020 and June 2021. All women had one or more risk factors for PPH.
The researchers tested three different routes of TXA administration: intramuscular injection, oral tablet and placebo. They found that both the injection and the tablet were well tolerated by the mothers and their babies, with no serious side effects.
However, while the tablet took an hour to reach therapeutic blood concentrations, the injection reached them within 10 minutes and maintained them for over four hours. This means that the injection could be suitable for emergency treatment, while the tablet could be unsuitable.
The authors conclude that these findings provide enough evidence to conduct a larger phase 3 trial with 30,000 women to further test the efficacy and safety of intramuscular TXA for PPH prevention and treatment. The trial, called I’M WOMAN, is expected to begin in August this year.
Professor Haleema Shakur-Still, co-author and Professor of Global Health Clinical Trials at LSHTM, said: “In many LMICs, women do not give births in healthcare facilities, so if TXA can be given just as successfully intramuscularly as via intravenous injection, this could be of huge significance to the thousands of women who die every year from PPH.”
She added: “We also envisage a situation where you have a pre-filled syringe with the drug that the police or ambulance can administer in an emergency.”
TXA was first used in surgery and later in trauma, where it has been proven to reduce mortality. It has also been used by paramedics in the UK since 2020 after a trial found it was effective. The military were the first to express an interest in an injectable form of TXA, which soldiers could carry in the field to use if they were injured.
The study was funded by The Wellcome Trust and supported by The Bill & Melinda Gates Foundation.