Trial reportBMJ (Clinical research ed.)2026
Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial.
Trial report in BMJ (Clinical research ed.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05811676 (Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China
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Authors and funding
37 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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%). 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)
conclusionsIn 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 registrationClinicalTrials.gov NCT05811676.
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