Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Feb 10;7(2):e012766.
doi: 10.1136/bmjopen-2016-012766.

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

L Dudley  1   2 , C Kettle  3 , P W Thomas  4 , K M K Ismail  5
Affiliations
Randomized Controlled Trial

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

L Dudley et al. BMJ Open. .

Erratum in

  • Correction.
    [No authors listed] [No authors listed] BMJ Open. 2017 Mar 7;7(3):e012766corr1. doi: 10.1136/bmjopen-2016-012766corr1. BMJ Open. 2017. PMID: 28270393 Free PMC article. No abstract available.

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.

Keywords: Dehiscence; Expectancy; Perineum; Postnatal; Re-suturing.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Plan of pilot RCT. RCT, randomised controlled trial.
Figure 2
Figure 2
CONSORT flow. CONSORT, Consolidated Standards of Reporting Trials.
Figure 3
Figure 3
Meta-analysis of two studies for wound healing.
See this image and copyright information in PMC

References

    1. Royal College of Obstetricians and Gynaecologists (RCOG). Methods and materials used in perineal repair, guideline no 23. London: Royal College of Obstetricians and Gynaecologists press kettle C, O'Brien PMS, 2004.
    1. National Institute for Health and Care Excellence (NICE). Postnatal care: routine postnatal care for women and their babies: nice clinical guideline no 37. London: National Institute for Health and Care Excellence, 2006.
    1. Steen M. Perineal tears and episiotomy: how do wounds heal? Br J Midwifery 2007;15:273–80. 10.12968/bjom.2007.15.5.23399 - DOI
    1. Fox E. Challenges: perineal wound care in the community, part one. World Ir Nurs 2011;19:48–50.
    1. Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nur 2012;21(5):S28, S30, S32–5. - PubMed

Publication types

Associated data

LinkOut - more resources