Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia

BackgroundStandardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. ObjectivesTo map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategyRandomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteriaRandomised controlled trials. Data collection and analysisWe systematically extracted and categorised outcome reporting. Main resultsSeventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. ConclusionsMost randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Tweetable abstractFuture #preeclampsia research requires a core outcome set to reduce #research waste. International Prospective Register of Systematic Reviews: CRD42015015529; . Tweetable abstract Future #preeclampsia research requires a core outcome set to reduce #research waste. International Prospective Register of Systematic Reviews: CRD42015015529; . This paper includes Author Insights, a video abstract available at .