Title: Perineal re-suturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): A pilot randomised controlled study.
Funder: Department of Health (England)

Abstract: Background Each year approximately 350,000 women in the United Kingdom experience perineal suturing following childbirth (RCOG 2004). The postpartum management of perineal trauma is a core component of routine maternity care. However for those women whose perineal wound dehisces (breaks down) the management will vary according to individual practitioners preferences. For most women the wound will be managed expectantly (healing by secondary intention) whereas others may be offered re-suturing as there is limited scientific evidence and no clear guidelines to inform best practice. Therefore it is timely to assess what is the best management of dehisced perineal wounds during the early postnatal period, in terms of clinical effectiveness and women’s preferences. Aims The aim of this study (PREVIEW) is to conduct a pilot RCT to test the study protocol; gauge the acceptability of the research plan to participants, clinicians and the organisations involved; estimate likely recruitment rates; loss to follow up rates due to attrition or otherwise and to collect data to inform the sample size calculation for a full scale RCT. Ultimately we are aiming to carry out the pilot study to reduce uncertainties in planning and conducting a full scale RCT to test the relative effectiveness of the interventions (re-suturing versus healing by expectancy) . Plan of Investigation We plan to recruit 180 participants from 4 research sites, over 18 months. Following informed written consent, computer randomisation will be used to allocate the interventions. The primary outcome will be the proportion of women with a healed perineal wound at 6-8 weeks from trial entry. Secondary outcomes measured at 6 weeks, 3 and 6 months after trial entry, will be perineal pain, the woman’s satisfaction with aesthetic results of the wound, dyspareunia, and rates of breast feeding. Information will be collected using validated questionnaires. To help ensure that the definitive trial captures outcomes that are relevant to women, we will also conduct a small number of interviews to assess women’s unique views of the impact of perineal wound dehiscence on their wellbeing. Potential Impact This study addresses an area of clinical research that has been extremely neglected and has the potential of making a significant impact on women’s health and wellbeing. For those who suffer from dehisced perineal wounds it can take up to 16 weeks to heal if treated expectantly and can leave the new mother feeling very traumatised. Hence, they may request that any subsequent deliveries are by caesarean section to avoid further perineal damage. The results of this study will inform a definitive RCT that will provide conclusive evidence of what is the best management of perineal wound dehiscence. If re-suturing proves to be effective this will potentially lead to significant improvements in perineal care and will help to reduce the short and long term morbidity experienced by women.


Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH