Obstetric anesthesia

Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery

N Engl J MedPublished Randomised controlled trial

Primary resultResult — go to the resultAdjusted relative risk 0.89 95.26% CI 0.74–1.07

Authors' conclusion

Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo.

Study context

Population
Patients undergoing cesarean delivery at 31 US hospitals
Participants
11,000 patients
Comparison
TXA vs placebo after umbilical-cord clamping
  • Tranexamic acidn = 5,529
  • Placebon = 5,471reference
Primary endpoint
Composite of:
  • Maternal death
  • Blood transfusion
Follow-up
By hospital discharge or 7 days post partum, whichever came first
Methodological detailsplacebo-controlled, multicentre
  • Placebo-controlled
  • Multicentre

Primary result

As reported in the abstract

Adjusted relative risk

0.89

95.26% CI 0.74–1.07

P = 0.19

Events by treatment group

Tranexamic acid vs Placebo
adjusted RR 0.89 (95.26% CI 0.74–1.07); P = 0.19

Secondary outcomes

OutcomeTranexamic acidPlaceboRR (95% CI)
Estimated intraoperative blood loss >1 liter (major secondary outcome)7.3%8.0%0.91 (0.79–1.05)
Interventions for bleeding complications16.1%18.0%0.90 (0.82–0.97)

g per deciliter

OutcomeTranexamic acidPlaceboMean difference (g per deciliter) (95% CI)
Change in hemoglobin level (preoperative to postoperative)−1.8−1.9−0.1 (−0.2 to −0.1)

Safety

OutcomeTranexamic acidPlaceboRR (95% CI)
Postpartum infectious complications3.2%2.5%1.28 (1.02–1.61)

Thromboembolic events and other adverse events

Similar in the two groups

Original publication

Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery. N Engl J Med. Published 13 April 2023. doi:10.1056/nejmoa2207419

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