6/30/23, 12:47 AM WOMAN Pathway Feedback Search Clinical Topics Home Studies WOMAN WOMAN Disease Postpartum hemorrhage Trial question What is the effect of early tranexamic acid administration in women with postpartum hemorrhage? Study design Multi-center Double blinded RCT Population 20060 female patients Inclusion criteria: women 16 years with a clinical diagnosis of postpartum hemorrhage after vaginal birth or C-section Key exclusion criteria: consideration of a clear indication or contraindication for tranexamic acid by the responsible clinician Interventions N=10051 tranexamic acid (an intravenous dose of 1 g plus usual care) N=10009 placebo (matching placebo plus usual care) Primary outcome Death due to bleeding 1.9 % 1.9 1.5 1.4 % 0.9 % Significant decrease 0.5 % NNT = 250 0.0 % Tranexamic acid Placebo Significant decrease in death due to bleeding (1.5% vs. 1.9%; RR 0.81, 95% CI 0.65 to 1) https://web.pathway.md/studies/recb1MQWkuhUOQzS9 1/2 6/30/23, 12:47 AM WOMAN Pathway Secondary outcomes No significant difference in death from all causes or hysterectomy at day 42 (5.3% vs. 5.6%; RR 0.97, 95% CI 0.87 to 1.09) Significant decrease in death due to bleeding in women given treatment within 3 hours of giving birth (1.2% vs. 1.7%; RR 0.69, 95% CI 0.52 to 0.91) No significant difference in hysterectomy (3.6% vs. 3.5%; RR 1.02, 95% CI 0.88 to 1.07) Safety outcomes No significant difference in adverse events including thromboembolic events. Significant differences in use of brace sutures (3.0% vs. 2.5%), laparotomy for bleeding (0.8% vs. 1.3%). Conclusion In women 16 years with a clinical diagnosis of postpartum hemorrhage after vaginal birth or C- section, tranexamic acid was superior to placebo with respect to death due to bleeding. Reference WOMAN Trial Collaborators. 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. Open reference URL https://web.pathway.md/studies/recb1MQWkuhUOQzS9 2/2