Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial
- 1The Maternity Centre, University Hospital of North Staffordshire, Stoke-on-Trent, Staffordshire, UK
- 2Faculty of Health, Staffordshire University, Blackheath Lane, Stafford, UK
- 3Arthritis Research UK National Primary Care Centre, Primary Care Services, Keele University, Staffordshire, UK
- 4Clinical Research Unit, School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK
- 5School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
- Correspondence to Professor Khaled M Ismail;
- Received 9 May 2012
- Accepted 22 June 2012
- Published 24 July 2012
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.
To cite: Dudley L, Kettle C, Carter P, et al. Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial. BMJ Open 2012;2:e001458. doi:10.1136/bmjopen-2012-001458
Contributors All authors contributed equally to this work. LD, CK and KMI conceived the idea for the study. PT and LD will perform the statistical analysis for the study. LD is the PREVIEW Study coordinator and the lead research midwife for the study. She is registered as a PhD student at Staffordshire University, and the PREVIEW Study will form part of her doctoral studies. All authors contributed to the design of the study. PC provided qualitative advice and support. All authors helped to draft the manuscript and all authors read and approved the final manuscript.
Funding PREVIEW is funded by research grant from the National Institute for Health Research, Research for Patient Benefit (PB-PG-090920079) and sponsored by the University Hospital of North Staffordshire. The trial coordinator (LD) has also received a Doctoral Nursing Studentship award from the Smith and Nephew Foundation/Research into Ageing (RIA) Age Concern (2008–2011). The sponsor organisation in collaboration with the trial management group has overall responsibility for ensuring that the PREVIEW Study is conducted in accordance with the Department of Health Research Governance Framework for Health and Social Care.23 The sponsor organisation will guarantee that there are appropriate arrangements in place: to initiate, manage and monitor the research; to finance the study and to report the outcomes of the research. The Chief Investigator (CI) and the trial steering committee have a contractual obligation to inform both the NIHR and RIA of any publications, which result from the research study. This relates to all publications generated from the research, including the scientific and lay press, abstracts and conference proceedings. The award holders also have a contractual obligation to submit an end of project report to the NIHR and RIA outlining the outcomes of PREVIEW. The report will detail a comprehensive overview of the work undertaken, summarise the research findings, any variation to the work outlined in the proposal or the research team and describe the next steps to patient benefit and the dissemination strategy. Additionally, the Research Investigators under the conditions of NHS Participant Identification Centre Agreements have a responsibility to share the learning from the research and provide the relevant Clinical Research Networks, Research Management and Governance Consortiums with: (1) the literature review from the research protocol, (2) interim findings from the research, when available and (3) a final report or summary of the research.
Competing interests CK and KMI run perineal repair workshops both nationally and internationally and have developed an episiotomy and second-degree tear training model with Limbs & Things, UK. They receive a small royalty fee that contributes towards women's health research funds.
Ethics approval Ethics approval was provided by the North Wales Research Ethics Committee.
Provenance and peer review Not commissioned; internally peer reviewed.
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