Tranexamic Acid Efficacy in Preventing Postpartum Hemorrhage After Elective C-Section to be Assessed in Large RCT

Postpartum haemorrhage (PPH) is a critical global health concern, accounting for approximately 25% of maternal deaths worldwide and ranking as the second leading cause in Zimbabwe. Despite the routine administration of prophylactic uterotonics like oxytocin, PPH remains a significant challenge, leading to substantial maternal morbidity and mortality. Current standard-of-care measures often fall short in completely preventing PPH, highlighting an urgent need for complementary interventions. Tranexamic acid (TXA), a synthetic lysine analogue, is a well-established antifibrinolytic agent widely used to reduce blood loss in various surgical settings, trauma, and menorrhagia by inhibiting plasminogen activation and fibrinolysis. Its mechanism of action complements uterotonic agents by stabilizing clots and enhancing the body's natural haemostatic processes, making it a promising candidate for PPH prevention.

Investigators are conducting an open-label randomized controlled study involving 1,162 women undergoing elective caesarean section. Participants will be randomly assigned to either receive an intravenous infusion of TXA or not. The intervention group will receive TXA 10 minutes prior to skin incision. All women in both arms will receive prophylactic oxytocin as per standard care. The primary endpoint is the incidence of PPH, defined as blood loss equal to or exceeding 1,000ml. Blood loss will be calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section, providing an objective measure of significant blood loss.

This abstract describes the protocol for an ongoing randomized controlled trial; therefore, no study results or findings are available yet. The investigators aim to determine the efficacy of Tranexamic Acid in reducing the incidence of Postpartum Haemorrhage following elective caesarean section. The study is designed to be adequately powered to validate or refute the routine use of TXA in this clinical setting, providing robust evidence for clinical practice guidelines. The primary outcome will be the incidence of PPH, defined as blood loss of 1,000ml or more, assessed by haematocrit changes.