Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
- Conditions
- Episiotomy; DehiscenceDehiscence WoundSecondary Perineal Tear
- Interventions
- Other: Clinical examination and picturesOther: Questionnaire
- Registration Number
- NCT06026423
- Lead Sponsor
- Herlev Hospital
- Brief Summary
The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing.
Participants will be asked to do
* A gynecological examination at one month after birth and 9-12 months after birth.
* Have a picture taken of the healing process
* Answer a questionnaire at one month, three months, and 9-12 months after birth
- Detailed Description
The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence.
The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management.
All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Women with a vaginal delivery who have had a primary repair of a second-degree perineal tear or episiotomy
- At least 18 years old
- Able to understand, read and speak Danish or English
- Able to give informed consent
- None, first, third- and fourth-degree tear
- Cesarean Section
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dehisced wound treated with conservative management Clinical examination and pictures 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management Normal/uncomplicated healing process Clinical examination and pictures 100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process Dehisced wound treated with conservative management Questionnaire 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management Dehisced wound treated with secondary resuturing Questionnaire 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing Normal/uncomplicated healing process Questionnaire 100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process Dehisced wound treated with secondary resuturing Clinical examination and pictures 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing
- Primary Outcome Measures
Name Time Method Body image 9-12 months Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
- Secondary Outcome Measures
Name Time Method Re-admission Within one month The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.
Fecal incontinence One month, three months, and 9-12 months Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)
Pain intensity One month, three months, and 9-12 months Self-reported pain intensity measured by Visual Analog Scale (VAS-score). Numeric rating scale from 0-10 (0 = no pain - 10 = pain as bad as can be)
Prolapse One month, three months, and 9-12 months Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Urinary incontinence One month, three months, and 9-12 months Measured by the ICIQ-UI SF questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Psychological well-being (maternal anxiety or depression) Three months, and 9-12 months Measured by Edinburgh Postnatal Depression Scale (EPDS). EPDS is a self-assessment questionnaire consisting of ten statements and the respondent is asked about their feelings over the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Denmark, women are said to have depressive symptoms after delivery if they score 11 or higher
Wound healing One month The proportion of women with healed wounds at one month post-partum assessed by clinical examination and REEDA scale (Redness, Oedema, Ecchymosis, Discharge, Approximation of the wound edges). The REEDA scale contains five criteria each receiving a score between 0 and 3. The total score range from 0 - 15 with lower scores representing better-wound healing
Infection rate One month The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale
Dyspareunia One month, three months, and 9-12months Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Woman´s satisfaction with the aesthetic results of the perineal wound One month, three months, and 9-12 months Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound
Resuming sexual intercourse One month, three months, and 9-12 months Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Affected breastfeeding One month, three months, and 9-12 months The woman will be asked whether she is breastfeeding or not
Pelvic floor muscle contraction One month and 9-12 months Measured by Modified Oxford scale
Consuming painkillers because of pain due to perineal tear One month, three months, and 9-12 months The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)
Trial Locations
- Locations (1)
Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
🇩🇰Herlev, Denmark