23 Completeness of outcome and outcome measure reporting across seventy-nine randomised trials, 31,615 participants, evaluating therapeutic interventions for pre-eclampsia: A systematic review

Abstract

Introduction Pre-eclampsia is an enigmatic, pregnancy specific, multisystem syndrome associated with significant maternal and offspring mortality and morbidity. Therapeutic interventions which reduce this health burden are urgently required. While much attention has been paid to standardising randomised trial methods, the collection and reporting of outcomes in randomised trials has been largely overlooked. Objectives To map the availability of maternal, fetal, neonatal, and childhood outcomes and outcome measures across randomised trials evaluating therapeutic interventions for pre-eclampsia. Methods Design: Systematic review of randomised trials. Data sources: Randomised controlled trials identified by searching: [1] Cochrane Central Register of Controlled Trials, [2] MEDLINE, [3] EMBASE, [4] PsycINFO, and [5] Cumulative Index to Nursing and Allied Health Literature from the inception of the database to January 2016. Study selection and methods: All randomised trials evaluating any therapeutic intervention for pre-eclampsia were included. We systematically extracted and organised outcomes reported in included trials. Results Seventy-nine randomised trials, including data from 31,615 maternal and 28,172 offspring participants, were included. Ninety-five different outcomes were reported. Of the seventy-nine included trials, 43 trials reported fetal outcomes, 23 trials reported neonatal outcomes, and six trials reported childhood outcomes. Less than half of included trials reported any relevant information regarding harms for maternal or offspring participants. Conclusions Most 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 clinically relevant minimum core data set, in future pre-eclampsia trials could help to address these issues. Systematic review registration International Prospective Register of Systematic Reviews: CRD42015015529.