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

NCT06026423 | Recruiting

• 1 other identifier: H-23022460
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Dehiscence Wound; Secondary Perineal Tear; Episiotomy; Dehiscence

Keywords

Dehiscence; Secondary Perineal Tear; Episiotomy

Outcome Measures

Primary Outcomes (1)

• Body image

  Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale

  9-12 months

Secondary Outcomes (14)

• Wound healing

  One month

• Infection rate

  One month

• Resuming sexual intercourse

  One month, three months, and 9-12 months

• Dyspareunia

  One month, three months, and 9-12months

• Woman´s satisfaction with the aesthetic results of the perineal wound

  One month, three months, and 9-12 months

Study Arms (3)

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; Other: Questionnaire

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; Other: Questionnaire

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; Other: Questionnaire

Interventions

Clinical examination and pictures OTHER

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.

Dehisced wound treated with conservative management; Dehisced wound treated with secondary resuturing; Normal/uncomplicated healing process

Questionnaire OTHER

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; Dehisced wound treated with secondary resuturing; Normal/uncomplicated healing process

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None, first, third- and fourth-degree tear
• Cesarean Section

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

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

Herlev, DK-2730, Denmark

RECRUITING

MeSH Terms

Interventions

Restraint, Physical; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hanna M. Jangö, MD, PhD

  Copenhagen University Hospital - Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lærke V. Moestrup, PhD student

CONTACT

+45 21351767; laerke.vinberg.moestrup@regionh.dk

Hanna M. Jangö, MD, PhD

CONTACT

+45 38381612; hanna.margareta.jangoe@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff specialist, Ph.D., Associated professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: September 15, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

DK (1)