Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical examination and pictures, Questionnaire.
- Who it may be relevant to
- Registry conditions: Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
Overview
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.
Interventions
- Other Clinical examination and pictures
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. - Other Questionnaire
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.
Primary outcome measures
- Body image [Time frame: 9-12 months]
Secondary outcome measures (12)
- Wound healing [Time frame: One month]
- Infection rate [Time frame: One month]
- Resuming sexual intercourse [Time frame: One month, three months, and 9-12 months]
- Dyspareunia [Time frame: One month, three months, and 9-12months]
- Woman´s satisfaction with the aesthetic results of the perineal wound [Time frame: One month, three months, and 9-12 months]
- Affected breastfeeding [Time frame: One month, three months, and 9-12 months]
- Re-admission [Time frame: Within one month]
- Prolapse [Time frame: One month, three months, and 9-12 months]
- Urinary incontinence [Time frame: One month, three months, and 9-12 months]
- Fecal incontinence [Time frame: One month, three months, and 9-12 months]
- Psychological well-being (maternal anxiety or depression) [Time frame: Three months, and 9-12 months]
- Pain intensity [Time frame: One month, three months, and 9-12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gent — Herlev
Identifiers
NCT: NCT06026423 · H-23022460