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To test the impact of 1g of tranexamic acid after cesarean delivery on the incidence of postpartum hemorrhage (PPH).
In a multicenter, double-blind, randomized controlled trial, we randomly assigned women with a cesarean before or during labor at ≥ 34 gestation weeks to receive a prophylactic uterotonic and 1 g of tranexamic acid (TXA) or placebo. The primary outcome was an objective calculated blood loss > 1000 ml or a red blood cell transfusion by Day 2 after delivery. Secondary outcomes were other measures of postpartum blood loss and potential adverse effects of TXA up to 3 months after delivery.
Of the 4551 randomized women, 4431 had cesareans, 4153 of whom (93.7%) were assessed for primary outcome. The primary outcome occurred in 556 of 2086 women (26.7%) in the TXA and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P<0.01). Mean rates for blood loss-related laboratory outcomes were lower in the TXA than the placebo group: mean calculated blood loss (680±748 versus 787±750 ml) and mean peripartum change in hemoglobin and hematocrit (all adjusted P-values <0.001). There were no significant between-group differences in the rates of these hemorrhage-related outcomes: mean gravimetrically estimated blood loss, provider-assessed clinically significant PPH, use of additional uterotonic agents, and postpartum transfusion (all adjusted P>0.05). Vomiting or nausea was more frequent in the TXA than the placebo group (42.7% versus 35.9%, adjusted P<0.001). At 3 months postpartum, thromboembolic events had occurred in 0.4% (8/2079) of the TXA and 0.1% (2/2086) of the placebo group (adjusted risk ratio, 3.99; 95% CI, 0.85 to 18.81; adjusted P=0.08).
Among women with cesarean receiving prophylactic uterotonics, tranexamic acid treatment resulted in a significantly lower rate than placebo of calculated blood loss > 1000 ml or transfusion by day 2, but did not reduce hemorrhage-related secondary clinical outcomes (ClinicalTrials.gov numberNCT03431805).