Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial (Protocol)

BACKGROUND: Each year, approximately 350 000 women in the UK experience perineal suturing following childbirth. For those women whose perineal wound dehisces, the management will vary according to individual practitioner's preferences. For most women, the wound will be managed expectantly (healing by secondary intention), whereas others may be offered resuturing. However, there is limited scientific evidence and no clear guidelines to inform best practice. PREVIEW is a two-part study aiming to identify the best management strategy for dehisced perineal wounds, in terms of clinical effectiveness and women's preferences. METHODS/DESIGN: The main part of this study is a pilot and feasibility randomised controlled trial designed to provide preliminary evidence of the effectiveness of resuturing versus expectant management for dehisced perineal wounds following childbirth and to feed into the design and feasibility of a larger definitive trial. 144 participants will be randomly allocated to either intervention. The primary outcome is the proportion of women with a healed perineal wound at 6-8 weeks from the trial entry. Secondary outcomes include perineal pain, breast feeding rates, dyspareunia and women's satisfaction with the aesthetic results of the wound healing at 6 weeks, 3 months and 6 months post randomisation. Information will be collected using validated questionnaires. The second part of this study will be to conduct semistructured interviews with 12 study participants, aiming to capture information relating to their physical and psychological experiences following perineal wound dehiscence, assess the acceptability of the research plan and ensure that all outcomes relevant to women are included in the definitive trial. DISSEMINATION: The results of this study will inform a definitive randomised controlled trial that will provide conclusive evidence of what is the best management of perineal wound dehiscence. This will potentially lead to significant improvements in perineal care and will help to reduce the short- and long-term morbidity experienced by women. CLINICAL TRIALS REGISTRATION: PREVIEW is registered with the International Standard Research for Clinical Trials (no: ISRCTN05754020) and adopted as a National Institute for Health Research (NIHR) Reproductive Health and Childbirth specialty group portfolio study UKCRN ID 9098