Comparison Of Suture Materials on Sectio Scars (COSMOSS)

Uterine Scar Clinical Trial

— COSMOSS  

Official title:

COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096910
• Other study ID #: 10840098-772.02-E.43598
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2021
• Source: Uludag University
• Contact: Kiper Aslan, M.D.
• Phone: +905548127272
• Email: kiperaslan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Uterine Scar

Intervention

Procedure:
• Uterine Closure with monofilament or polyfilament suture materials
Postoperative 6th-month isthmocele rates

Locations

Country	Name	City	State
Turkey	Uludag University Scholl of medicine	Bursa	Turkey/bursa

Sponsors (4)

Lead Sponsor	Collaborator
Uludag University	Bursa Medicana Hospital, Ceylan Hospital, UMI Health Center

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isthmocele Rate	diagnosis of isthmocele during 6th month ultrasound check.	6 months