The World Health Organization (WHO) is recommending early use of tranexamic acid to treat bleeding after childbirth after fresh analysis of the WOMAN trial was published in The Lancet.
The study showed that major bleeds must be treated with the drug as fast as possible since deaths occur quickly and the drug’s life-saving benefits diminish with each passing minute.
The WOMAN trial (2017), which involved 20,000 women with severe bleeding after childbirth (postpartum haemorrhage), and CRASH-2 (2010) - a trial of 20,000 trauma patients – both showed that tranexamic acid reduces death due to bleeding by a third when given within three hours.
In the new analysis of data from 40,138 patients from the two trials combined, the research team, led by the London School of Hygiene & Tropical Medicine, found that treatment must be given within minutes rather than hours. Immediate treatment with tranexamic acid improved bleeding survival by 70% but thereafter the survival benefit decreases by 10% for every 15 minutes’ delay until three hours, after which there was no benefit.
There was a total of 3,558 deaths in the two trials, of which 1,408 (40%) were from bleeding. Most (63%, 884 deaths) bleeding deaths occurred within 12 hours of onset. Deaths from postpartum haemorrhage (PPH) peaked 2-3 hours after childbirth.
Traumatic bleeding kills over 2 million people each year and PPH, the leading single cause of maternal deaths worldwide, claims the lives of around 100,000 women each year, mostly in low and middle-income countries. The researchers are calling for tranexamic acid to be used worldwide as a frontline treatment to help reduce the global burden of deaths from severe bleeding. Following a detailed review of evidence from the WOMAN trial plus the new analysis, WHO recently published updated recommendations on the use of tranexamic acid. The previous guidelines in 2012 - before the WOMAN Trial results were known - recommended use of tranexamic acid if other treatments failed. It now strongly recommends early use of intravenous tranexamic acid (within three hours of birth) in addition to standard care for women with clinically-diagnosed PPH following vaginal birth or caesarean section. WHO also highlighted the need for all health systems, regardless of their level of resources, to recognise that tranexamic acid is a life-saving intervention that should be made readily available for PPH management wherever emergency obstetric care is provided.
Senior study author, Professor Ian Roberts from the London School of Hygiene & Tropical Medicine, said: “For women with postpartum haemorrhage, bleeding deaths peak at two hours, so it is crucial that tranexamic acid is given as soon as life-threatening bleeding is diagnosed.” The new research findings are part of the discussion at a special event on postpartum haemorrhage taking place at the London School of Hygiene & Tropical Medicine. The event brings together leading experts from the UK, Nigeria and Pakistan, including researchers involved in the WOMAN trial, and also marks the launch of the Blood Clock, a unique art installation which raises awareness of postpartum haemorrhage and the need for urgent treatment.
Speaking at the event is Her Excellency Toyin Saraki, Founder-President of Wellbeing Foundation Africa and ambassador for the International Confederation of Midwives. The Nigerian philanthropist and maternal health campaigner said: “PPH is a major problem in Nigeria and across much of Africa, so it is extremely important that we can find practical solutions which could improve the chances of survival. I am delighted that we now have even more evidence about the potential benefits of tranexamic acid – which is simple to administer, safe and relatively inexpensive compared with patented medicines. Now we need to make sure it’s made available.”
