[Accepted Manuscript] Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials
AbstractPostpartum haemorrhage is the leading cause of maternal mortality. Tranexamic acid (TXA) reduces surgical haemorrhage and the risk of death in bleeding trauma patients. To assess the effects of TXA on risk of postpartum haemorrhage and other clinically relevant outcomes. We searched the MEDLINE, CENTRAL, EMBASE, PubMed, ClinicalTrials.gov and WHO ICTRP electronic databases to May 2015. Randomised controlled trials comparing TXA with no TXA or placebo in women giving birth vaginally or by caesarean section. Two authors extracted data and assessed the risk of bias for each trial. Because of data concerns we did not conduct a meta-analysis. 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. 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. No evidence that TXA prevents postpartum haemorrhage. Existing trials are unreliable, with serious flaws.
Ker, K. <http://researchonline.lshtm.ac.uk/view/creators/101095.html>; Shakur, H. <http://researchonline.lshtm.ac.uk/view/creators/101846.html>; Roberts, I. <http://researchonline.lshtm.ac.uk/view/creators/100700.html>; (2016) [Accepted Manuscript] Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG <http://researchonline.lshtm.ac.uk/view/publication/BJOG_.html>. ISSN 1470-0328 (In Press)