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Obstetrics & critical care · Antifibrinolytics in obstetric haemorrhage

WOMAN randomised trial

Early tranexamic acid administration in women with post-partum haemorrhage

WOMAN trial design and results
Design International randomised, double-blind, placebo-controlled trial
Treatment Tranexamic acid
Control Placebo
Population 20,060 women with post-partum haemorrhage: 10,051 tranexamic acid and 10,009 placebo
Follow-up 42 days
Primary endpoint Composite of death from all causes or hysterectomy
Result Tranexamic acid reduced death due to bleeding with no adverse effects, among the 20,021 women who received the allocated treatment.
Secondary endpoints Hysterectomy, thromboembolic events, surgical interventions

Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset.

The trial authors, in the published abstract

How it has aged

A cheap, widely available drug saving lives at scale, and now standard worldwide. The contrast with HALT-IT in gastrointestinal bleeding is instructive: same drug, same rationale, opposite result — the site of bleeding matters.

Publications

Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet 2017 May 27;389(10084):2105-2116.

  • Reduced death due to bleeding
  • No increase in thromboembolic events
  • 20,060 women randomised