Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE

Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity despite standard active management of the third stage of labor. Evidence regarding the prophylactic use of tranexamic acid (TA) after vaginal delivery, particularly according to PPH risk stratification, is limited. This study aimed to evaluate the efficacy of prophylactic intravenous tranexamic acid administered after vaginal delivery in reducing postpartum blood loss. The primary outcome was measured blood loss during the third and fourth stages of labor. Secondary outcomes included the incidence of uterine atony, need for blood transfusion, requirement for additional uterotonics, and treatment-related adverse effects, assessed separately in low- and high-risk PPH groups.

MATERIALS AND

METHODS

This double-blind, prospective, randomized controlled trial included 480 singleton pregnant women aged 18-45 years who delivered at ≥ 34 weeks of gestation. Participants were first stratified according to postpartum hemorrhage (PPH) risk as low-risk (n = 240) or high-risk (n = 240). Within each risk group, women were randomly assigned in a 1:1 ratio to receive either intravenous tranexamic acid (1 g) or placebo after vaginal delivery (120 participants per treatment arm in each risk group).

RESULTS

In low-risk patients, both the collected blood volume and estimated blood loss were significantly lower in the tranexamic acid (TA) group compared with placebo. In high-risk patients, TA administration was associated with significantly reduced collected blood volume and estimated blood loss, as well as a lower incidence of uterine atony. In addition, the need for blood transfusion and additional uterotonic use was lower in patients receiving TA, particularly in the high-risk group. No clinically significant differences were observed in laboratory safety parameters, including D-dimer levels.

CONCLUSION

Prophylactic tranexamic acid administration after vaginal delivery significantly reduced postpartum blood loss compared with placebo. While TA was effective in reducing blood loss in both low- and high-risk patients, a significant reduction in uterine atony was observed only in the high-risk group. No major adverse effects related to TA were identified, suggesting that TA was well tolerated in the study population. Major maternal morbidity outcomes were not assessed in this study.