Journal Summary: The WOMAN trial: RCT

Tranexamic acid for PPH reduces maternal deaths without increasing clotting complications.

WOMAN trial collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomized, double-blind, placebo-controlled trial. Lancet 2017: doi.org/10.1016/S0140-6736(17)30638-4

Summary

Post partum hemorrhage is a leading cause of maternal mortality globally. There is evidence from trauma trials that tranexamic acid reduces mortality from massive hemorrhage. The WOMAN study examined whether tranexamic acid could reduce mortality or hysterectomy from post-partum hemorrhage.

This trial recruited 20,060 women, the majority from low-income countries, with post-partum hemorrhage of > 500mls at vaginal birth or > 1000mls at caesarean section. Participants were randomized to 1g intravenous tranexamic acid or placebo. A second dose could be given after 30 minutes at the discretion of the clinician.

They found a significant reduction in mortality from bleeding with tranexamic administration. This was most significant when tranexamic acid was administered within 3 hours of delivery: 89 deaths (1.2%) in the tranexamic acid group vs 127 (1.7%) in the placebo group (NNT = 200). The hysterectomy rate was similar between groups, which may have resulted from many participants being randomized to the trial at time of hysterectomy. Importantly, there was no increase in deep vein thrombosis or pulmonary embolism following tranexamic acid administration. 

Clinical implications

Tranexamic acid 1g IV reduces the risk of death from post-partum hemorrhage, with the greatest benefit if given within 3 hours of delivery. There is no evidence of increased venous thromboembolic events with treatment. The number of women needed to treat to prevent one maternal death is 200.

Resources

Related journals

View all journals