Safety and Efficacy of Prophylactic Tranexamic Acid in Reducing Postpartum Hemorrhage After Cesarean Delivery in Women with Systemic Autoimmune Disease A Randomized Controlled Trial

What this Trial Is About

Postpartum hemorrhage (PPH) is a leading cause of pregnancy-related death among women with high-risk cesarean deliveries, especially those with systemic autoimmune diseases such as systemic lupus erythematosus, antiphospholipid syndrome, and rheumatoid arthritis. These diseases increase the risk of adverse pregnancy outcomes including PPH, preeclampsia, and thromboembolism. This trial aims to evaluate the safety and effectiveness of using tranexamic acid (TXA) to prevent PPH in women with systemic autoimmune diseases undergoing cesarean delivery, addressing a gap in current research focused mainly on low-risk women. Participants undergoing cesarean delivery are randomly assigned to receive either an intravenous infusion of 1 gram of tranexamic acid or a placebo (normal saline) 10 minutes before skin incision. The study compares blood loss during and after surgery, the need for blood transfusions, additional uterine contraction medications, and surgical interventions for PPH. Follow-up includes monitoring for thromboembolic events and maternal and neonatal outcomes up to three months after delivery. Throughout the study, participants will be closely monitored for blood loss from surgery until one day post-operation, as well as for any complications up to three days after surgery. The trial also tracks the volume of blood transfusions and any additional treatments needed for PPH. Maternal and neonatal health will be followed for three months to assess safety and long-term outcomes. This randomized, quadruple-blind trial helps provide evidence to guide care for women with systemic autoimmune diseases at high risk of PPH.

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage