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Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials
Author(s) -
Ker K,
Shakur H,
Roberts I
Publication year - 2016
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.14267
Subject(s) - tranexamic acid , medicine , childbirth , clinical trial , randomized controlled trial , placebo , meta analysis , caesarean section , medline , relative risk , maternal death , postpartum haemorrhage , postpartum period , intensive care medicine , obstetrics , pregnancy , confidence interval , alternative medicine , surgery , population , blood loss , environmental health , pathology , biology , political science , law , genetics
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.