Comparing conservative treatment and resuturing for perineal wound dehiscence after vaginal delivery
Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
This study is testing whether treating perineal wound dehiscence after vaginal delivery with conservative methods or resuturing helps women heal better in the short and long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06026423 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the short and long-term outcomes for women experiencing perineal wound dehiscence after childbirth. It will compare conservative management with secondary suturing in women who have had a primary repair of a second-degree tear or episiotomy. Participants will undergo gynecological examinations, have pictures taken of their healing process, and complete questionnaires at various intervals post-delivery. The study seeks to provide evidence to guide best practices in managing perineal wound dehiscence.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have had a vaginal delivery with a primary repair of a second-degree perineal tear or episiotomy.
Not a fit: Patients with first, third, or fourth-degree tears, or those who had a cesarean section will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for women suffering from perineal wound dehiscence, enhancing their recovery and quality of life.
How similar studies have performed: This study addresses a gap in existing literature, as there is currently no consensus on the best management approach for perineal wound dehiscence, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev
- Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Hanna M. Jangö, MD, PhD — Copenhagen University Hospital - Herlev and Gentofte
- Study coordinator: Lærke V. Moestrup, PhD student
- Email: laerke.vinberg.moestrup@regionh.dk
- Phone: +45 21351767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.