THE TRIAL EXPLAINED
The WOMAN trial, coordinated by the London School of Hygiene & Tropical Medicine (LSHTM) Clinical Trials Unit (CTU) is an international clinical trial of the effect of tranexamic acid on death, hysterectomy and other maternal outcomes, in women with PPH.14
The trial tested whether tranexamic acid, a blood clot stabiliser that was discovered in Japan in the 1950’s, could become an essential tool for fighting excessive bleeding soon after giving birth. This condition, known as postpartum haemorrhage, is the number one cause of maternal death around the world, particularly in low and middle income countries.
The premise for the WOMAN trial came from the results of the 2010 CRASH2 trial, which showed that tranexamic acid reduces death due to bleeding after serious injury with no apparent increase in thrombotic events.
The CRASH-2 trial enrolled 20,211 bleeding trauma patients from hospitals in 40 countries and showed that tranexamic acid reduces death due to bleeding with no apparent increase in thrombotic events.10 Given soon after injury, tranexamic acid reduces bleeding deaths by a third.11 tranexamic acid is easy to use, heat stable and highly cost-effective.12
There have been a number of small trials of tranexamic acid in obstetric bleeding, most of which show a decrease in blood loss but the quality of the trials is poor and none are large enough to assess the effect of tranexamic acid on maternal outcomes.13 As pregnant women have a heightened risk for thrombosis compared with the general population it is important to assess the efficacy and associated risks of tranexamic acid in this group in this group.
The trial started recruitment in March 2010 and was a global collaboration of obstetricians, midwives, pharmacists, administrators, ethics committees and regulatory agencies that has led to the recruitment of hundreds of women with PPH each month from hospitals worldwide. The trial completed recruited in April 2016, recruiting a total of 20,060 women, from 193 hospital in 21 countries.
The trial findings show that if used within 3 hours, tranexamic acid reduced death due to bleeding by about a third. This means the lives of about one in three mothers who would otherwise bleed to death after childbirth could be saved. The trial findings also show that tranexamic acid reduced the need for urgent surgery to control bleeding (laparotomy) by more than a third and the trial found no increase in complications from the drug for either mothers or babies.
For the full trial results, please visit our results page and use and share the content to raise awareness of the findings.
For more information, view our WOMAN trial summary flyer
