Comparison Of Suture Materials on Sectio Scars (COSMOSS)

Bursa Uludag University

Status: Unknown

Conditions: Uterine Scar

Treatments: Procedure: Uterine Closure with monofilament or polyfilament suture materials

Study type: Interventional

Funder types: Other

Identifiers

NCT05096910

10840098-772.02-E.43598

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Monofilament Suture Group

Active Comparator group

Description:

Monofilament sutures will be used for uterine closure.

Treatment:

Procedure: Uterine Closure with monofilament or polyfilament suture materials

Polyfilament Suture Group

Active Comparator group

Description:

Polyfilament sutures will be used for uterine closure.

Treatment:

Procedure: Uterine Closure with monofilament or polyfilament suture materials