Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery

NCT03806348 | Unknown

• 1 other identifier: Paris2018
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 is better to resuture early or leave the rupture for secondary healing.

Conditions

Wound; Perineal Rupture, Dehiscence

Outcome Measures

Primary Outcomes (1)

• Need of late perineal reconstruction

  Digital palpation of the perineal body and assessment of thickness. POP-Q score; nine points in the vagina are identified. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The measurements are taken when the Valsalva maneuver is performed by the woman. Anovaginal distance using perineal ultrasound. Validated scales to identify specific symptoms from the perineum and to identify the feeling of vaginal wideness and the need for digital assistance during defecation. PFDI 20- short form-version of pelvic floor distress inventory FSFI - female sexual function index PFIQ - pelvic floor impact questionnaire

  One year

Secondary Outcomes (11)

• Pelvic floor symptoms and the impact on quality of life

  One year

• Pelvic floor symptoms and the impact on quality of life

  One year

• Sexual function

  One year

• Wound healing

  2 weeks

• Wound healing

  4 weeks

Study Arms (2)

Resuturing

EXPERIMENTAL

Early resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.

Procedure: Resuturing

Conservative treatment

NO INTERVENTION

Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.

Interventions

Resuturing PROCEDURE

Early reconstruction of the perineal body after wound dehiscence within two weeks of delivery.

Resuturing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stockholm South General Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Stockholm South General Hospital

Stockholm, 11883, Sweden

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Marion Ek, PhD, MD

  Department of Obstetrics and Gynecology, Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Drca, MD

CONTACT

+46705618733; anna.lundmark-drca@sll.se

Denise Golmann, MD

CONTACT

+46707478144; denise.golmann@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 16, 2019
• Study Start: December 12, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)