BACKGROUND: Each year approximately 350,000 women in the United Kingdom (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 re-suturing. However, there is limited scientific evidence and no clear guidelines to inform best practice. DESIGN: PREVIEW was a four-phase study, using a sequential range of quantitative and qualitative paradigms including: • A Cochrane systematic review (phase 1) • A comparative retrospective case note audit (phase 2) • A national electronic survey (phase 3) • A multi-centre pilot and feasibility randomised controlled trial (RCT) (phase 4, part 1) and semi-structured interviews with women who participated in the RCT (phase 4, part 2). Phase four was the main component of the study. AIMS AND OBJECTIVES: Phase 1: • Evidence synthesis for the therapeutic effectiveness of secondary suturing of dehisced perineal wounds following childbirth compared to non-suturing. Phase 2: • Explore risk factors associated with perineal wound dehiscence, with the use of a logistic regression model. Phase 3: • Survey current practice relating to the current management of dehisced perineal wounds from a representative cohort of RCOG members. Phase 4: • Establish the feasibility of conducting a definitive RCT comparing re-suturing of dehisced perineal wounds versus expectant management. • Provide preliminary evidence of the effectiveness of re-suturing versus expectant management for dehisced perineal wounds following childbirth. • Explore women's experiences of living with a dehisced perineal wound. METHODS: Phase 1: A systematic review of RCTs investigating re-suturing versus expectancy for dehisced perineal wounds following childbirth. This was conducted in accordance with Cochrane guidance. Phase 2: Case notes from women with perineal wound dehiscence (n=100) were compared with case notes from women with no dehiscence (n=100) using an audit tool developed in accordance with NHS Litigation Authority guidance. Phase 3: National electronic survey of members of the Royal College of Obstetricians and Gynaecologists. Phase 4: A mixed methods study where participants with a dehisced perineal wound were recruited to one of ten participating centres and randomised to either re-suturing or expectant management. The primary outcome for the RCT was time taken to heal. The secondary outcomes were: pain, dyspareunia, women's satisfaction with the aesthetic results of healing and breast feeding. A purposive sample of women who participated in the RCT were interviewed for the qualitative study. RESULTS: Phase 1: The Cochrane systematic review (2 studies n=52 women) recommended that there was an urgent need for a robust randomised trial to fully evaluate the comparative effects of both treatment options. Phase 2: The audit (n=200 case notes) revealed that episiotomy was an increased risk factor for perineal wound dehiscence. Phase 3: The national survey (n=53 respondents) confirmed the lack of evidence based guidelines to support clinical practice. Phase 4: The mixed methods study revealed a number of feasibility issues, particularly relating to a strong patient preference for a treatment option and researcher/clinician engagement at recruiting centres which would need careful consideration before proceeding to a definitive study. Thirty four women were randomised in the pilot RCT (17 in each arm). A further 95 women were eligible but not randomised. Data from 33 women were analysed on an intention to treat analysis. There was a trend for increased wound healing at 2 weeks following randomisation, Odds Ratio (OR) 20.00 95% Confidence Interval (CI) (2.04, 196.37) P = 0.004 but no difference at 6 weeks. Findings from the interviews (n=6) revealed 4 emerging themes: physical impact, psychosocial impact, sexual impact, satisfaction with healing and an 'a priori' theme participating in the RCT. CONCLUSIONS: This study has contributed to the paucity of literature surrounding perineal wound dehiscence. The results of the RCT should be interpreted with some caution due to the relatively small numbers included in the final analysis, mostly due to patient preference for a treatment option. However, there was a significant trend to favour re-suturing for the primary outcome measure of wound healing and the overall findings of phase four show that a further study is feasible. Furthermore, data from this study will be included in future updates of the Cochrane review published in 2013 and presented in chapter three of this thesis.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:659365 |
| Date | January 2014 |
| Creators | Dudley, Lynn |
| Publisher | Staffordshire University |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://eprints.staffs.ac.uk/2167/ |
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