A drug that is low cost and easy to administer may help prevent maternal deaths, according to results of a randomized clinical trial presented at The Pregnancy Meeting. Conducted by French investigators, the research showed that when given to women who had delivered vaginally and received prophylactic antibiotics, tranexamic acid is associated with lower risk of postpartum hemorrhage (PPH) than placebo without higher risk of severe adverse events (AEs).
Nearly 4,000 women participated in the trial held at multiple centers in France, exceeding the number required to demonstrate a 30% decrease in the primary outcome (incidence of postpartum blood loss ≥ 500 mL). All of the women had planned vaginal delivery at term ≥ 35 weeks with a singleton live fetus. They were randomized to receive, in labor, either 1g of intravenous tranexamic acid or placebo plus prophylactic oxytocin within 2 minutes after delivery. Besides measuring PPH using a graduated collector bag, the authors also looked at measures of PPH and potential AEs of the drug up to 3 months after delivery.
PPH hemorrhage occurred in 8.1% of the women (151) in the tranexamic acid group versus 9.8% of the women (188) who received placebo (95% CI, 0.68-1.01; P = 0.07). The women who received the drug also had lower incidences of PPH > 500 mL and clinically significant PPH compared with the participants who received placebo (6.6% versus 8.8%; P = 0.01 and 7.8% versus 10.4%; P = 0.04, respectively). Additional uterotonics were required in 9.7% of the women who received placebo versus 7.3% of the tranexamic acid group (P = 0.003).
Regarding AEs, the investigators found that nausea and vomiting in labor were more common in the women who received tranexamic acid (7.0% versus 3.2%; P < 0.001) but there were no significant differences in thrombotic events or other AEs between the two groups.
In a subgroup analysis, tranexamic acid was found to reduce PPH in women who had instrumental delivery (9.6% versus 14.5%; RR 0.66; 95% CI 0.44-1.0; P = 0.0498) but not women who delivered spontaneously or those with versus without episiotomies (12.3% versus 17.3%; RR 0.73; 95% CI 0.53-1.00; P = 0.049).
“Tranexamic acid should be considered for women who deliver via operative vaginal delivery and episiotomy in conjunction with prophylactic oxytocin,” said lead author Loïc Sentilhes, MD, PhD, in a statement released by the Society for Maternal-Fetal Medicine. “At the dosage studied, the only side effect observed was an increase in nausea and vomiting.