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

• ClinicalTrials.gov Identifier: NCT06026423
• Recruitment Status: Recruiting
• First Posted: September 7, 2023
• Last Update Posted: September 18, 2023
• Sponsor: Herlev Hospital
• Information provided by (Responsible Party): Hanna Jangö, Herlev Hospital

Study Description

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

Condition or disease	Intervention/treatment
Dehiscence Wound; Secondary Perineal Tear; Episiotomy; Dehiscence	Other: Clinical examination and pictures; Other: Questionnaire

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
• Actual Study Start Date: September 15, 2023
• Estimated Primary Completion Date: September 1, 2024
• Estimated Study Completion Date: September 1, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
Normal/uncomplicated healing process; 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; 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.
Dehisced wound treated with secondary resuturing; 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing	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.
Dehisced wound treated with conservative management; 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management	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.

Outcome Measures

Primary Outcome Measures :

1. Body image [ Time Frame: 9-12 months ]
   Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale

Secondary Outcome Measures :

1. Wound healing [ Time Frame: 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
2. Infection rate [ Time Frame: One month ]
   The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale
3. Resuming sexual intercourse [ Time Frame: 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)
4. Dyspareunia [ Time Frame: 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)
5. Woman´s satisfaction with the aesthetic results of the perineal wound [ Time Frame: 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
6. Affected breastfeeding [ Time Frame: One month, three months, and 9-12 months ]
   The woman will be asked whether she is breastfeeding or not
7. Re-admission [ Time Frame: Within one month ]
   The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.
8. Prolapse [ Time Frame: 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)
9. Urinary incontinence [ Time Frame: 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)
10. Fecal incontinence [ Time Frame: 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)
11. Psychological well-being (maternal anxiety or depression) [ Time Frame: 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
12. Pain intensity [ Time Frame: 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)
13. Consuming painkillers because of pain due to perineal tear [ Time Frame: 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)
14. Pelvic floor muscle contraction [ Time Frame: One month and 9-12 months ]
    Measured by Modified Oxford scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

We want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with an uncomplicated healing process. They will only be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospital - Herlev. Furthermore, we want to include 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. They will be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospitals - Rigshospitalet, Herlev Hospital, North Zealand Hospital, and Hvidovre Hospital. The women will come for a clinical examination to assess wound infection and healing 4 - 14 days post-partum.

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

Contacts and Locations

Contacts

Contact: Lærke V. Moestrup, PhD student; +45 21351767; laerke.vinberg.moestrup@regionh.dk

Contact: Hanna M. Jangö, MD, PhD; +45 38381612; hanna.margareta.jangoe@regionh.dk

Locations

Denmark

Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte; Recruiting

Herlev, Denmark, DK-2730

Contact: Hanna M. Jangö, MD, PhD, Associate Professor +4538681612 hanna.jango@regionh.dk

Principal Investigator: Hanna M. Jangö, MD, PhD, Associate Professor

Sub-Investigator: Lærke V. Moestrup, Midwife, MSc, PhD-student

Sub-Investigator: Thomas Bergholt, Prof., Chief Physician, PhD

Sub-Investigator: Hanne K. Hegaard, Prof., Midwife, PhD

Sub-Investigator: Niels Klarskov, Prof., Chef Physician, DMSc

Sponsors and Collaborators

Herlev Hospital

Investigators

• Principal Investigator: Hanna M. Jangö, MD, PhD; Copenhagen University Hospital - Herlev and Gentofte

More Information

• Responsible Party: Hanna Jangö, Staff specialist, Ph.D., Associated professor, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT06026423
• Other Study ID Numbers: H-23022460
• First Posted: September 7, 2023
• Last Update Posted: September 18, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanna Jangö, Herlev Hospital:

Dehiscence; Secondary Perineal Tear; Episiotomy

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes