Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

Abstract

Background Selecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials. Objective To evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma. Search strategy Randomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE. Selection criteria Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations. Data collection and analysis Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman's ρ correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis. Main results Forty‐eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13). Conclusion Outcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues.</p