TRAAP
Trial question
What is the role of prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in the incidence of postpartum hemorrhage in females with vaginal delivery?
Study design
Multi-center
Double blinded
RCT
Population
3891 female patients.
Inclusion criteria: females in labor who had a planned vaginal delivery of a singleton live fetus at ≥ 35 weeks of gestation and were receiving prophylactic oxytocin after delivery.
Key exclusion criteria: increased risk of venous or arterial thrombosis or bleeding, a history of epilepsy or seizure, or poor comprehension of oral French.
Interventions
N=1921 tranexamic acid (1 g dose IV over a period of 30-60 seconds during the 2 minutes after delivery).
N=1918 placebo (normal saline).
Primary outcome
Postpartum hemorrhage of at least 500 ml
8.1%
9.8%
9.8 %
7.4 %
4.9 %
2.5 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
No significant difference in postpartum hemorrhage of at least 500 ml (8.1% vs. 9.8%; RR 0.83, 95% CI 0.68 to 1.01).
Secondary outcomes
Significant decrease in provider-assessed clinically significant postpartum hemorrhage (7.8% vs. 10.4%; RR 0.74, 95% CI 0.61 to 0.91).
Significant decrease in the use of additional uterogenic agents (7.2% vs. 9.7%; RR 0.75, 95% CI 0.61 to 0.92).
Significant decrease in blood loss > 500 mL in the collector bag (6.6% vs. 8.8%; RR 0.75, 95% CI 0.6 to 0.94).
Safety outcomes
No significant difference in adverse events at 3 months.
Significant difference in non-severe frequency of vomiting or nausea in the delivery room (7.0% vs. 3.2%).
Conclusion
In females in labor who had a planned vaginal delivery of a singleton live fetus at ≥ 35 weeks of gestation and were receiving prophylactic oxytocin after delivery, tranexamic acid was not superior to placebo with respect to postpartum hemorrhage of at least 500 ml.
Reference
Sentilhes L, Winer N, Azria E et al. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742.
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