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

Perineal REpair following Vaginal delivery complicated by an Infected Episiotomy Wound: a feasibility study for a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05754020
Enrollment
250
Registered
2009-01-16
Start date
2009-04-01
Completion date
Unknown
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehisced perineal wounds Pregnancy and Childbirth Perineal laceration during delivery

Interventions

The participants will be computer randomised into either immediate resuturing of their dehisced perineal wound in comparison to healing by secondary intention. Both groups will have an independent ass

Sponsors

University Hospital of North Staffordshire NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Time taken for the dehisced perineal wound to heal, assessed at 2 weeks, 6 weeks, 3 months and 6 months, respectively. 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: 'PREVIEW' Independent Perineal Assessment 2 weeks, and 'PREVIEW' Independent Assessment 6 weeks 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: 'PREVIEW' Mothers questionnaire 6 weeks 'PREVIEW' Mothers questionnaire 3 months 'PREVIEW' Mothers questionnaire 6 months

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026