Comparison Of Suture Materials on Sectio Scars (COSMOSS)

Not Applicable

• Conditions: Uterine Scar
• Interventions: Procedure: Uterine Closure with monofilament or polyfilament suture materials

• Registration Number: NCT05096910
• Lead Sponsor: Uludag University

Brief Summary

This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

Detailed Description

The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.

Study Timeline

• Study Start: 2020-09-04
• Status Verified: 2021-10
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 18-40 yrs women
• Primary elective cesarean section
• First delivery
• Without any systemic diseases

Exclusion Criteria

• emergent delivery
• previous c-section history
• congenital uterine abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofilament Suture Group	Uterine Closure with monofilament or polyfilament suture materials	Monofilament sutures will be used for uterine closure.
Polyfilament Suture Group	Uterine Closure with monofilament or polyfilament suture materials	Polyfilament sutures will be used for uterine closure.

Primary Outcome Measures

Name	Time	Method
Isthmocele Rate	6 months	diagnosis of isthmocele during 6th month ultrasound check.

Trial Locations

Locations (1)

Uludag University Scholl of medicine; 🇹🇷 Bursa, Turkey/bursa, Turkey