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

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

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

Study Overview

• Status: Recruiting
• Conditions: Episiotomy; Dehiscence; Dehiscence Wound; Secondary Perineal Tear
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Lærke V. Moestrup, PhD student; Phone Number: +45 21351767; Email: laerke.vinberg.moestrup@regionh.dk
• Study Contact Backup: Name: Hanna M. Jangö, MD, PhD; Phone Number: +45 38381612; Email: hanna.margareta.jangoe@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, DK-2730
    • Recruiting
    • Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
    • Contact: Hanna M. Jangö, MD, PhD, Associate Professor; Phone Number: +4538681612; Email: hanna.jango@regionh.dk
    • Principal Investigator: Hanna M. Jangö, MD, PhD, Associate Professor
    • Sub-Investigator: Lærke V. Moestrup, Midwife, MSc, PhD-student
    • Sub-Investigator: Hanne K. Hegaard, Prof., Midwife, PhD
    • Sub-Investigator: Niels Klarskov, Prof., Chef Physician, DMSc
    • Sub-Investigator: Thomas Bergholt, Prof., Chief Physician, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Episiotomy; Dehiscence; Secondary Perineal Tear
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: H-23022460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No