Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial

AbstractObjectiveTo investigate whether prophylactic tranexamic acid reduces the incidence of postpartum haemorrhage in women with placenta praevia compared with placebo.DesignRandomised, double blind, placebo controlled, phase 3 study.Setting24 maternity units across China between July 2023 and March 2025.Participants1732 women with placenta praevia undergoing caesarean delivery.InterventionsParticipants were randomly (1:1) assigned to receive prophylactic oxytocin and either tranexamic acid (1 g in 10 mL) or placebo (10 mL normal saline) diluted in 40 mL normal saline intravenously over 10 minutes, initiated within five minutes of umbilical cord clamping.Main outcome measuresThe primary outcome was postpartum haemorrhage, defined as calculated estimated blood loss ≥1000 mL or as red cell transfusion within two days after delivery. Serious adverse events included thromboembolic events, seizures, acute kidney or liver injury, and maternal death.ResultsOf 1732 women with placenta praevia who were randomised, 38 were excluded because they withdrew consent or were determined to be ineligible after randomisation.

Primary outcome data were available for 99.8% (1691/1694) of the remaining women. Placenta accreta spectrum was diagnosed in 303 participants (17.9%).