WOMAN
Trial question
What is the effect of early tranexamic acid administration in patients with postpartum hemorrhage?
Study design
Multi-center
Double blinded
RCT
Population
20060 female patients.
Inclusion criteria: female patients ≥ 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
1.5%
1.9%
1.9 %
1.4 %
0.9 %
0.5 %
0.0 %
Tranexamic
acid
Placebo
Significant
decrease ▼
NNT = 250
Significant decrease in death due to bleeding (1.5% vs. 1.9%; RR 0.81, 95% CI 0.65 to 1).
Secondary outcomes
No significant difference in all-cause mortality 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 female patients ≥ 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.
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