The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial
Primary resultResult — go to the resultRelative risk 1.05 95% CI 0.94–1.19Authors' conclusion
In women with moderate and severe anaemia, giving tranexamic acid within 15 min of the umbilical cord being clamped did not reduce the risk of clinically diagnosed postpartum haemorrhage.
Study context
- Population
- Women in active labour with moderate or severe anaemia (haemoglobin <100 g/L) who gave birth vaginally; Nigeria, Pakistan, Tanzania, Zambia
- Participants
- 7,580 vs 7,488
- Comparison
- Tranexamic acid vs Placebo
- Tranexamic acidn = 7,580
- Placebon = 7,488reference
- Primary endpoint
- Clinical diagnosis of primary PPH (estimated blood loss >500 mL or any blood loss compromising haemodynamic stability)
- Follow-up
- Within 24 h of randomisation
Methodological detailsinternational, double-blind, placebo-controlled, 34 hospitals in 4 countries, Recruited Aug 24, 2019, to Sept 19, 2023
- International
- Double-blind
- Placebo-controlled
- 34 hospitals in 4 countries
- Recruited Aug 24, 2019, to Sept 19, 2023
Primary result
As reported in the abstract
Relative risk
1.05
95% CI 0.94–1.19
Events by treatment group
Tranexamic acid vs Placebo
RR 1.05 (95% CI 0.94–1.19)
Further findings
Prespecified subgroups (interaction)
- Severity of anaemia
- P = 0.44
- Antepartum haemorrhage
- P = 0.044
- Birth canal trauma
- P = 0.37
- Use of pain control
- P = 0.37
- Baseline risk of PPH
- P = 0.31
- No strong evidence against homogeneity of effects
Time from start of treatment to PPH diagnosis
- Median, all
- 18.5 min (IQR 5-58)
- Median, moderate anaemia
- 20 min (8-64)
- Median, severe anaemia
- 13 min (7-44)
- PPH diagnosed before treatment fully administered
- 358 (35%) of 1024
Safety
Events
| Outcome | Tranexamic acid | Placebo |
|---|---|---|
| Vascular occlusive events (PE, DVT, stroke, MI) | 0 | 0 |
Treatment-related adverse events and deaths
- No treatment-related adverse events and no treatment-related deaths
Original publication
The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial. Lancet. Published 26 October 2024. doi:10.
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