Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06026423

Dehisced Perineal Tear After Vaginal Labour - Conservative Treatment or Resuturing

Led by Herlev Hospital · Updated on 2023-09-18

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to better understand the short- and long-term outcomes for women who experience an uncomplicated healing process or wound dehiscence after a second-degree perineal tear or episiotomy following vaginal childbirth. The study compares conservative management and secondary suturing for treating perineal wound dehiscence, addressing the current lack of clear treatment recommendations. Investigators seek to enroll 300 women divided into three groups based on their healing status and treatment approach. Participants include women with normal healing, those with dehisced wounds treated with secondary resuturing, and those with dehisced wounds managed conservatively. Standard care is followed, with the study adding two extra clinical examinations and questionnaires. Clinical exams and photographs of the perineal healing process occur at one month and again between nine to twelve months after birth, while questionnaires are completed at one, three, and nine to twelve months postpartum. Women will undergo gynecological exams and have photos taken to document healing. They will also complete questionnaires assessing body image, pain, urinary and anal incontinence, sexual health, breastfeeding impact, and psychological well-being at specified intervals. Researchers will monitor wound healing, infection rates, readmissions, pelvic floor function, and other outcomes during follow-up. The study duration covers assessments up to 12 months after childbirth to track healing and related health effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • First, third, and fourth-degree perineal tears
  • Cesarean section delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months postpartum

Participants undergo clinical examinations and provide questionnaires to assess the healing process and related symptoms after vaginal delivery and perineal tear management.

3 clinical examinations and 3 questionnaire assessments over 9 to 12 months

Trial Site Locations

Total: 1 location

1

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

Herlev, Denmark, DK-2730

Actively Recruiting

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Research Team

L

Lærke V. Moestrup, PhD student

H

Hanna M. Jangö, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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