• K Ker, H Shakur, and I Roberts.
• Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
• BJOG. 2016 Oct 1; 123 (11): 1745-52.

BackgroundPostpartum haemorrhage is the leading cause of maternal mortality. Tranexamic acid (TXA) reduces surgical haemorrhage and the risk of death in bleeding trauma patients.ObjectivesTo assess the effects of TXA on risk of postpartum haemorrhage and other clinically relevant outcomes.Search StrategyWe searched the MEDLINE, CENTRAL, EMBASE, PubMed, ClinicalTrials.gov and WHO ICTRP electronic databases to May 2015.Selection CriteriaRandomised controlled trials comparing TXA with no TXA or placebo in women giving birth vaginally or by caesarean section.Data Collection And AnalysisTwo authors extracted data and assessed the risk of bias for each trial. Because of data concerns we did not conduct a meta-analysis.Main ResultsWe 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.ConclusionsThere 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 AbstractNo evidence that TXA prevents postpartum haemorrhage. Existing trials are unreliable, with serious flaws.© 2016 Royal College of Obstetricians and Gynaecologists.

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