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

OBJECTIVE

To investigate whether prophylactic tranexamic acid reduces the incidence of postpartum haemorrhage in women with placenta praevia compared with placebo.

DESIGN

Randomised, double blind, placebo controlled, phase 3 study.

SETTING

24 maternity units across China between July 2023 and March 2025.

PARTICIPANTS

1732 women with placenta praevia undergoing caesarean delivery.

INTERVENTIONS: Participants 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 MEASURES: The 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.

RESULTS

Of 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%). The primary outcome occurred in 29.7% (251/845) of the tranexamic acid group and 35.1% (297/846) of the placebo group (relative risk 0.85, 95.2% confidence interval (CI) 0.75 to 0.96; P=0.01). The rates of serious adverse events were similar between the tranexamic acid group and placebo group (0.5% (4 of 837) v 0.5% (4 of 845); relative risk 1.01, 95% CI 0.25 to 4.00).

CONCLUSIONS

In women with placenta praevia who underwent caesarean delivery and received prophylactic oxytocin, treatment with tranexamic acid resulted in a statistically significant yet modest reduction in the incidence of postpartum haemorrhage, with no signal of increased serious adverse events.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05811676.