Tranexamic acid in pregnant women with grade 1 abruption placentae: A double-blind, multicenter randomized clinical trial

<title>Abstract</title> <p>Background Grade 1 placental abruption presents significant management challenges. This study evaluated the efficacy of Tranexamic Acid (TXA) in reducing blood loss and improving perinatal outcomes. Methods A multicenter, double-blind, randomized controlled trial was conducted at five teaching hospitals in Iraq and one in Egypt (January 2023–February 2024). We enrolled 115 women with mild vaginal bleeding due to abruption, randomized to receive either TXA (n = 57) or a 5% Dextrose placebo (n = 58). Primary outcomes included bleeding cessation and a composite favorable perinatal outcome (birth weight ≥ 2500 g, Apgar score ≥ 7, and no neonatal intensive care unit admission). Results Bleeding cessation was observed in 93.0% of the TXA group versus 44.8% in the placebo group (OR = 11.17; 95% CI: 3.32–37.60; p &lt; 0.001), with a lower estimated blood loss (0.482 vs. 1.207 mL; p &lt; 0.001). Pregnancy prolongation was noted in the TXA arm, which demonstrated a higher mean gestational age at delivery (35.2 vs. 31.8 weeks) and a lower rate of preterm delivery (38.6% vs. 87.9%; {RR} = 0.439; p &lt; 0.001). Favorable perinatal outcomes were recorded at 75.4% with TXA versus 22.4% with placebo (p &lt; 0.001). Secondarily, the TXA group required fewer packed red blood cell transfusions (38.6% vs. 94.8%; p &lt; 0.001). No maternal thromboembolic or severe adverse events were observed. Conclusion In this sample, TXA was associated with reduced maternal blood loss, lower transfusion dependencies, and prolonged pregnancy, which may help mitigate preterm birth risks in Grade 1 placental abruption. Larger randomized controlled trials are required to confirm these findings and establish definitive clinical efficacy.</p>