Re-stitching of a broken down perineal wound compared to leaving it to heal naturally

Not Applicable

Completed

• Conditions: Dehisced perineal wounds; Pregnancy and Childbirth; Perineal laceration during delivery

• Registration Number: ISRCTN05754020
• Lead Sponsor: niversity Hospital of North Staffordshire NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-16
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. Women (aged 18 - 40 years) referred to the perineal care clinic at the University Hospital of North Staffordshire
2. Dehisced perineal wound (spontaneous second, third or fourth tear or episiotomy)
3. Occurs within two weeks following childbirth

Exclusion Criteria

1. Women that have not given their written consent to participate in the study
2. Women who have delivered a stillborn infant
3. Women under the age of 16 years
4. Women who cannot speak English or cannot read or write

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken for the dehisced perineal wound to heal, assessed at 2 weeks, 6 weeks, 3 months and 6 months, respectively.<br><br>An independent assessment of the primary outcome will be conducted at 2 weeks and 6 weeks using a questionnaire format, the title of the questionnaire being:<br>'PREVIEW' Independent Perineal Assessment 2 weeks, and <br>'PREVIEW' Independent Assessment 6 weeks<br><br>Mothers will also complete questionnaires at 6 weeks, 3 months and 6 months, respectively, also assessing primary and secondary outcomes, the title of these questionnaires being:<br>'PREVIEW' Mothers questionnaire 6 weeks<br>'PREVIEW' Mothers questionnaire 3 months<br>'PREVIEW' Mothers questionnaire 6 months

Secondary Outcome Measures

Name	Time	Method
1. Woman's satisfaction with aesthetic results of perineal wound at 6 months post-natal<br>2. Pain at 6 weeks, 3 and 6 months post-natal<br>3. Dyspareunia (painful intercourse) at 3 - 6 months<br>4. Rates of breastfeeding<br><br>Mothers will complete questionnaires at 6 weeks, 3 months and 6 months respectively, assessing primary and secondary outcomes, the title of these questionnaires being:<br>'PREVIEW' Mothers questionnaire 6 weeks<br>'PREVIEW' Mothers questionnaire 3 months<br>'PREVIEW' Mothers questionnaire 6 months