TRAPP-TRanexamic Acid for the prevention of Postpartum hemorrhage in pregnant women with placenta Previa: a multicenter randomized, double-blind, placebo-controlled trial

Abstract

Abstract Background The prophylactic use of tranexamic acid (TXA) has been shown to reduce blood loss in low-risk populations during cesarean deliveries. However, the effectiveness of TXA in reducing postpartum hemorrhage (PPH) in high-risk populations remains uncertain due to a lack of high-quality evidence. Therefore, conducting multicenter randomized controlled trials with sufficient statistical power is crucial to establish the persuasive value of TXA before its widespread use for PPH prevention pregnant women with placenta previa. Methods/Design:This study will be a multicenter randomized, double-blind, placeto-controlled trial with two parallel groups, including 1680 patients undergoing cesarean delivery with placenta previa. Participants will be randomly assigned to receive either tranexamic acid (1 g) or placebo intravenously immediately after birth. The primary outcome will be the incidence of PPH, defined as a calculated estimated blood loss exceeding 1000 mL or the need for red blood cell transfusion before postpartum day 2. With 80% statistical power, this study aims to demonstrate a 20% reduction in the incidence of PPH, from 33.0 to 26.4%. Discussion: Tranexamic acid is a cost-effective and easily accessible medication that shows promise in reducing the risk of PPH during cesarean delivery in high-risk patients, such as those with placenta previa. This large-scale, adequately powered, multicenter randomized placebo-controlled trial aims to determine whether the benefits of routine prophylactic use of tranexamic acid during cesarean delivery in patients with placenta previa outweigh its associated risks. Trial registration: ClinicalTrials.gov NCT05811676 (March 15, 2023).