Efficacy of tranexamic acid for the prevention of post-partum haemorrhage among women undergoing caesarean section in Harare, Zimbabwe: A randomized controlled trial

Abstract

Post-partum haemorrhage (PPH) is a significant cause of maternal mortality in Zimbabwe and Africa. Despite easy access and availability of oxytocin to treat PPH, incidence cases of maternal mortality from PPH still occur, thus additional interventions are needed to prevent PPH. This parallel, double-blind, closed label randomized clinical trial was carried out to determine the efficacy of prophylactic administration of tranexamic acid (TXA) before caesarean section to prevent PPH. In a blinded, 2-centre, randomized control trial with 2 parallel groups that enrolled 1,224 participants who had an elective or emergency caesarean delivery at term, we randomly assigned them to receive 1 g (10 mL) of TXA or 10 mL normal saline at the onset of skin incision. All participants in the study and control group received the standard care of 5 IU intravenous oxytocin on delivery of the baby. The primary outcome was occurrence of PPH, defined by an estimated blood loss exceeding 1,000 mL using laboratory haematocrit values taken before and after the procedure. Six-hundred and thirteen (613) participants were randomized to receive placebo and 611 received TXA. Adjusted analysis from a generalized linear model showed that there was no statistically significant association between the risk of PPH and TXA administration (adjusted relative risk = 1.07; 95% confidence interval = 0.87–1.31). There was no effect modification by type of caesarean section, whether a participant had an emergency or elective caesarean section. TXA did not cause significant adverse events during the clinical trial. Prophylactic administration of TXA before a caesarean section did not significantly reduce the risk of PPH compared to standard methods alone.