An inexpensive and widely available drug could save the lives of 1 in 3 mothers who would otherwise bleed to death after childbirth, according to a major study published in The Lancet.
More than 300 women from 5 hospitals in Bangladesh took part in the global trial, which included 20,000 women in 21 countries, mainly in Africa and Asia, the UK and elsewhere.
The drug, called tranexamic acid (TXA), works by stopping blood clots from breaking down. The study found that death due to bleeding was reduced by 31% if the treatment was given within three hours. The findings also show it reduced the need for urgent surgery to control bleeding by more than a third (36%).
Severe bleeding after childbirth (known as postpartum haemorrhage or PPH) is the leading cause of maternal death worldwide. Postpartum haemorrhage is defined as a blood loss of more than 500 ml within 24 hours of giving birth. More than 100,000 women globally die each year from the condition, but this clot-stabilising drug has the potential to reduce the number substantially.
According to the World Health Organisation (WHO) and partners, Bangladesh has a maternal mortality rate of 176 deaths per every 100,000 live births. In 2015 there were an estimated 5,500 maternal deaths in the country, and postpartum haemorrhage was the single biggest cause.
The London School of Hygiene & Tropical Medicine coordinated the study, which is called The WOMAN (World Maternal Antifibrinolytic) Trial. It was funded by The Wellcome Trust and UK Department of Health through the Health Innovation Challenge Fund, and the Bill & Melinda Gates Foundation.
Dr Kaosar Afsana, Director of Health, Nutrition and Population at BRAC (a leading international development organisation based in Bangladesh), is part of the WOMAN Trial committee. She said: "Post-partum haemorrhage is the prime cause of maternal deaths in Bangladesh. I am so excited about the results of the Woman Trial. Timely use of simple tranexamic acid will save many lives of mothers by averting unnecessary maternal deaths even in remote health facilities where there are no obstetricians or trained physicians."
Dr Afsana said that another research should be carried out in the community setting to explore the similar effect of the drug.
The results show that of the women given tranexamic acid within 3 hours, 89 died from bleeding compared with 127 given placebo (in addition to standard care). The researchers found no side effects from the drug for either mothers or babies. These findings provide the first comprehensive evidence on using tranexamic acid for post-partum haemorrhage and suggest it should be used as a frontline treatment.
Haleema Shakur, Associate Professor of Clinical Trials at the London School of Hygiene & Tropical Medicine and Project Director on the WOMAN Trial, said: “We now have important evidence that the early use of tranexamic acid can save women’s lives and ensure more children grow up with a mother. It’s safe, affordable and easy to administer, and we hope that doctors will use it as early as possible following the onset of severe bleeding after childbirth.”
Almost all of the deaths from postpartum haemorrhage are in low- and middle-income countries. Although giving birth in a health facility increases the chance of surviving post-partum haemorrhage, women still die from the condition even within hospitals.
While the WOMAN Trial found that tranexamic acid significantly reduced death due to bleeding, it did not prevent hysterectomy. The researchers say this is because in low- and middle-income countries where blood supplies are limited, a hysterectomy is sometimes carried out immediately after the onset of very severe post-partum haemorrhage to save the mother’s life. This means there is no time for tranexamic acid to have an effect.