Publication:

Role of prophylactic add on tranexamic acid in active management of third stage of labour: a prospective randomised study

Background Postpartum haemorrhage (PPH) remains the leading cause of maternal mortality worldwide. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent, and its established efficacy in reducing haemorrhage in trauma and surgical contexts. Its prophylactic use in the obstetric setting is of growing interest. This study aims to evaluate the efficacy and safety of prophylactic TXA (1 g intravenous) as an adjunct to oxytocin (10 IU intramuscular) in reducing postpartum blood loss and the incidence of PPH for active management of third stage of labour in women undergoing vaginal delivery.

Methods A prospective, double-blind, randomized controlled trial was conducted at a tertiary care teaching hospital, over 18 months. Eligible women with singleton pregnancies at ≥37 weeks of gestation expecting vaginal delivery were randomized 1:1 to group A (TXA 1 g IV slow infusion + oxytocin 10 IU IM; n=78) or Group B (10 ml normal saline IV + oxytocin 10 IU IM; n=78). Primary endpoints were total measured postpartum blood loss (ml) and incidence of PPH (≥500 ml). Secondary endpoints included reduction in level of haemoglobin at 24 hours, requirement for additional uterotonics, blood transfusion requirement, duration of third stage, adverse maternal effects, and neonatal outcomes.

Results Mean postpartum blood loss was significantly lower in group T than group O (72.56±30.94 ml versus 72.82±25.73 ml; p<0.05). PPH incidence was significantly reduced in the TXA group (8.97% versus 28.20%; OR: [0.25], RR: [0.32], 95% CI [0.14–0.70]; NNT=[6]; p<0.05). Mean haemoglobin fall, need for additional uterotonics, and blood transfusion rate were all significantly lower in group T. No significant difference in adverse effects, thromboembolic events, or neonatal outcomes was observed between groups.

Conclusions Prophylactic TXA 1 g iv as an adjunct to standard therapy significantly reduces postpartum blood loss and PPH incidence without increasing adverse maternal or neonatal outcomes.