Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials

Abstract

Background: Postpartum haemorrhage is the leading cause of maternal mortality. Tranexamic acid (TXA) reduces surgical haemorrhage and the risk of death in bleeding trauma patients.

Objectives: To assess the effects of TXA on risk of postpartum haemorrhage and other clinically relevant outcomes.

Search strategy: We searched the MEDLINE, CENTRAL, EMBASE, PubMed, ClinicalTrials.gov and WHO ICTRP electronic databases to May 2015.

Selection criteria: Randomised controlled trials comparing TXA with no TXA or placebo in women giving birth vaginally or by caesarean section.

Data collection and analysis: Two authors extracted data and assessed the risk of bias for each trial. Because of data concerns we did not conduct a meta-analysis.

Main results: We found 26 trials including a total of 4191 women. Examination of the trial reports raised concerns about the quality of the data. Eight trial reports contained identical or similar text and there were important data inconsistencies in several trials. Two trials did not have ethics committee approval. Meta-analysis of baseline variables suggested that randomisation was inadequate in many trials.

Conclusions: There is no reliable evidence that TXA prevents postpartum haemorrhage during childbirth. Many of the trials conducted to date are small, low quality and contain serious flaws.

Tweetable abstract: No evidence that TXA prevents postpartum haemorrhage. Existing trials are unreliable, with serious flaws.

Keywords: Postpartum haemorrhage; systematic review; tranexamic acid.