TRAAP2
Trial question
What is the role of tranexamic acid in females undergoing Cesarean delivery?
Study design
Multi-center
Double blinded
RCT
Population
4431 female patients.
Inclusion criteria: females undergoing Cesarean delivery at ≥ 34 gestational weeks.
Key exclusion criteria: previous episode of DVT or PE; increased risk of venous or arterial thrombosis or bleeding; history of epilepsy or seizure; prenatal hemoglobin level ≤ 9 g/dL in the week before delivery; autoimmune disease.
Interventions
N=2222 tranexamic acid (intravenous administration of prophylactic uterotonic agent and 1 g tranexamic acid).
N=2209 placebo (intravenous administration of prophylactic uterotonic agent and matching placebo).
Primary outcome
Postpartum hemorrhage
26.7%
31.6%
31.6 %
23.7 %
15.8 %
7.9 %
0.0 %
Tranexamic
acid
Placebo
Significant
decrease ▼
NNT = 20
Significant decrease in postpartum hemorrhage (26.7% vs. 31.6%; RR 0.84, 95% CI 0.75 to 0.94).
Secondary outcomes
No significant difference in gravimetrically estimated blood loss (689 mL vs. 719 mL; ARD -30.6, 95% CI -90.2 to 29).
No significant difference in clinically significant postpartum hemorrhage according to health care provider (13.6% vs. 14.8%; RR 0.92, 95% CI 0.79 to 1.08).
No significant difference in use of additional uterotonic agents for excessive bleeding (5.9% vs. 7.2%; RR 0.81, 95% CI 0.64 to 1.03).
Safety outcomes
No significant difference in thromboembolic events.
Significant difference in vomiting or nausea in the operating room (43.0% vs. 36.3%).
Conclusion
In females undergoing Cesarean delivery at ≥ 34 gestational weeks, tranexamic acid was superior to placebo with respect to postpartum hemorrhage.
Reference
Loïc Sentilhes, Marie V Sénat, Maëla Le Lous et al. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634.
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