Sentilhes L, et al. - In a multicenter, double-blind, randomized, controlled trial, researchers investigated the impact of administering the prophylactic tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery on the incidence of postpartum hemorrhage. Women with vaginal delivery receiving prophylactic oxytocin did not show a rate of postpartum hemorrhage of at least 500 ml with the use of tranexamic acid which was significantly lower than the rate with placebo.

Methods

• Researchers conducted a multicenter, double-blind, randomized, controlled trial including women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation.
• These women were randomized to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery.
• Postpartum hemorrhage was assessed as the primary outcome; it is defined as blood loss of at least 500 ml, measured with a collector bag.

Results

• Researchers randomized 4079 women; among these, 3891 had a vaginal delivery.
• In the tranexamic acid group, the primary outcome occurred in 156 of 1921 women (8.1%) vs in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07).
• Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04).
• The two groups did not differ significantly regarding other secondary outcomes.
• The tranexamic acid group and the placebo group showed no significant differences regrading the incidence of thromboembolic events in the 3 months after delivery (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24).