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

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Obstetrics and gynaecology
Research
Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial
  1. L Dudley1,2,3,
  2. C Kettle3,
  3. P W Thomas4,
  4. K M K Ismail5
    1. 1The Maternity Centre, Royal Stoke, University Hospitals of North Midlands, Staffordshire, UK
    2. 2Faculty of Health, Staffordshire University, Stafford, UK
    3. 3Faculty of Health Sciences, Professor Emerita of Women's Health, Staffordshire University, Stafford, UK
    4. 4Faculty of Health and Social Sciences, Professor of Health Care Statistics and Epidemiology, Bournemouth University Clinical Research Unit, Bournemouth University, Dorset, UK
    5. 5Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
    1. Correspondence to Professor K M K Ismail; k.ismail{at}bham.ac.uk

    Abstract

    Objective To establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds.

    Design A multicentre pilot and feasibility RCT.

    Setting Ten UK maternity units from July 2011 to July 2013.

    Population Eligible women with a dehisced perineal wound within 2 weeks of childbirth.

    Methods The interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat.

    Outcome The primary outcome measure was wound healing at 6–8 weeks.

    Results The study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6–8 weeks all but one wound in both groups had healed.

    Conclusions PREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months.

    Trial registration number ISRCTN05754020.

    • Postnatal
    • Perineum
    • Dehiscence
    • Re-suturing
    • Expectancy

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

    https://doi.org/10.1136/bmjopen-2016-012766

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      Footnotes

      • Collaborators A El-Mardi, K Powell, T Harrison and H Millward, County Hospital, University Hospital of North Midlands. A El-Naqa, K Cheshire and J Ickes, Royal Wolverhampton NHS Trust. A Tapp and K Henderson, Shrewsbury and Telford Hospital NHS Trust. K McKintyre, J Brown and C Dixon, Leighton Hospital, Mid Cheshire Hospitals, NHS Foundation Trust. A Sultan, R Thakar and A Johnson, Croydon University Hospital. L Page, L W Johnson and C Adamson, West Middlesex University Hospital. S Webb, Birmingham Women's NHS Foundation Trust. E Morris, F Fraser and K Kordtomeikel, Norfolk and Norwich University Hospitals NHS Foundation Trust. S Ismail, Brighton and Sussex University Hospital. S Jerreat, A Rooney and A Redford, Royal Stoke, University Hospital of North Midlands.

      • Contributors All authors contributed equally to this work. LD, CK and KMKI conceived the idea for the study. All authors contributed to the design of the study. LD performed the statistical analysis for the study supported by PWT. LD was the PREVIEW study coordinator, she completed the research as part of her doctoral studies at Staffordshire University.

      • Funding PREVIEW was funded by the National Institute for Health Research, Research for Patient Benefit (RfPB) (PB-PG-090920079) and sponsored by the Royal Stoke University Hospital. The trial coordinator (LD) also received a doctoral nursing studentship award from the Smith and Nephew Foundation/Research into Ageing (RIA) Age Concern (2008–2011).

      • Competing interests CK and KMKI run perineal repair workshops 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.

      • Patient consent Obtained.

      • Ethics approval PREVIEW was approved by the North Wales research ethics committee (Central and East) reference number: 10/WNo03/16.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data sharing statement Copies of trial protocol documents can be requested from LD Lynn.dudley@uhns.nhs.uk

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