Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

<bold>Background: </bold>Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions.<bold>Objective: </bold>To assess safety reporting in pre-eclampsia trials.<bold>Search Strategy: </bold>Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017.<bold>Selection Criteria: </bold>Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia.<bold>Data Collection and Analysis: </bold>Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting.<bold>Main Results: </bold>We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports.<bold>Conclusions: </bold>Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms.<bold>Funding: </bold>National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK.<bold>Tweetable Abstract: </bold>Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. [ABSTRACT FROM AUTHOR]