Status:
UNKNOWN
Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery
Lead Sponsor:
Stockholm South General Hospital
Conditions:
Wound; Perineal Rupture, Dehiscence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it i...
Detailed Description
140 women will be included in the trial, 70 women will be randomized to resuturing and 70 women will be randomized to expectant management. The investigators will follow the women with clinical invest...
Eligibility Criteria
Inclusion
- Woman over 18 years old who had a vaginal delivery and suffered from a perineal rupture, grade 2 (spontaneous or episiotomy).
- No longer than two weeks has passed since delivery.
- The woman must be able to give informed consent.
Exclusion
- Perineal rupture grade 3 and 4.
- Woman suffering from connective tissue disease.
- Ongoing treatment with oral cortisone or other immunosuppressive disease.
- Diabetes treated with insulin.
- Suspicion of occult damage of the anal sphincter.
- Earlier surgery of the perineum.
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03806348
Start Date
December 12 2018
End Date
January 1 2021
Last Update
January 16 2019
Active Locations (1)
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1
Department of Obstetrics and Gynecology, Stockholm South General Hospital
Stockholm, Sweden, 11883