Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing

Conditions
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Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence

Intervention / Treatment
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* Other: Clinical examination and pictures
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: None, first, third- and fourth-degree tear Cesarean Section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal/uncomplicated healing process<br>100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process | Other: Clinical examination and pictures<br>* A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.<br>Other: Questionnaire<br>* The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.<br>|
| Dehisced wound treated with secondary resuturing<br>100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing | Other: Clinical examination and pictures<br>* A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.<br>Other: Questionnaire<br>* The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.<br>|
| Dehisced wound treated with conservative management<br>100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management | Other: Clinical examination and pictures<br>* A clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.<br>Other: Questionnaire<br>* The participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body image | Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale | 9-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | 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 | One month | 
| Infection rate | The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale | One month | 
| Resuming sexual intercourse | Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | One month, three months, and 9-12 months | 
| Dyspareunia | Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | One month, three months, and 9-12months | 
| Woman´s satisfaction with the aesthetic results of the perineal wound | Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound | One month, three months, and 9-12 months | 
| Affected breastfeeding | The woman will be asked whether she is breastfeeding or not | One month, three months, and 9-12 months | 
| Re-admission | The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p. | Within one month | 
| Prolapse | Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) | One month, three months, and 9-12 months | 
| Urinary incontinence | 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) | One month, three months, and 9-12 months | 
| Fecal incontinence | Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B) | One month, three months, and 9-12 months | 
| Psychological well-being (maternal anxiety or depression) | 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 | Three months, and 9-12 months | 
| Pain intensity | 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) | One month, three months, and 9-12 months | 
| Consuming painkillers because of pain due to perineal tear | The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No) | One month, three months, and 9-12 months | 
| Pelvic floor muscle contraction | Measured by Modified Oxford scale | One month and 9-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dehiscence, Episiotomy, Secondary Perineal Tear