For those experiencing planned or unplanned cesarean delivery, administering intravenous Tranexamic acid immediately after umbilical cord clamping did not result in a significantly reduced likelihood of maternal death or the need for blood transfusion.

This randomized, double-blind trial was carried out to assess whether using Tranexamic acid right after umbilical cord clamping would result in a reduced likelihood of maternal death or blood transfusion compared to a placebo for women undergoing either planned or urgent cesarean delivery.

Volunteers undergoing cesarean delivery at 31 U.S. hospitals were randomly allocated to receive either Tranexamic acid or a placebo post umbilical-cord clamping. A composite of maternal mortality or blood transfusion risk by hospital discharge or within seven days postpartum, whichever occurred earlier was the key endpoint ascertained.

Significant secondary outcomes encompassed intraoperative blood loss exceeding 1 liter (defined as a key secondary endpoint), interventions for bleeding and associated complications, preoperative-to-postoperative alterations in levels of hemoglobin, and postpartum infectious complications. Evaluation of adverse events was also done.

Out of 11,000 volunteers randomly allocated (5529 in the Tranexamic acid group and 5471 in the placebo group), 50.1% and 49.2% respectively had scheduled cesarean deliveries. The key outcome event occurred in 3.6% of the Tranexamic acid group (201 out of 5525 subjects) and 4.3% of the placebo group (233 out of 5470 subjects) (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07). In the Tranexamic acid arm, 7.3% experienced intraoperative blood loss (obstetrical hemorrhage) exceeding 1 liter, compared to 8.0% in the placebo arm (relative risk [RR], 0.91; 95% CI, 0.79 to 1.05).

Interventions for bleeding complications were required in 16.1% of the Tranexamic acid group and 18.0% of the placebo group (RR, 0.90; 95% CI, 0.82 to 0.97). The alteration in hemoglobin levels was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1). Postpartum infectious complications took place in 3.2% and 2.5% of the participants, respectively (RR, 1.28; 95% CI, 1.02 to 1.61). The inter-group thromboembolic events and other noxious events were comparable in frequency.

The preventive administration of Tranexamic acid during cesarean delivery did not lead to a significantly diminished risk of the combined outcome of maternal mortality or blood transfusion compared to the use of a placebo.