'Royal College of Obstetricians & Gynaecologists (RCOG)'
Abstract
Background Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. Objectives To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Search strategy Randomised trials were identified by searching bibliographical databases from inception to January 2016. Selection criteria Randomised controlled trials. Data collection and analysis We systematically extracted and categorised outcomes reporting. Main results Seventy-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 (14%) trials reported maternal mortality, reporting data from 12,422 participants (39%), and 16 (20%) trials reported cardiovascular morbidity, reporting data from 14,963 maternal participants (43%). Forty-three (54%) trials reported fetal outcomes and 23 (29%) trials 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. 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 minimum core data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues
