Comparison Of Suture Materials on Sectio Scars (COSMOSS) (COSMOSS)

October 26, 2021 updated by: GÜRKAN UNCU,PROF. MD, Uludag University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Turkey/bursa
      • Bursa, Turkey/bursa, Turkey
        • Recruiting
        • Uludag University Scholl of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Monofilament Suture Group
Monofilament sutures will be used for uterine closure.
Procedure: Uterine Closure with monofilament or polyfilament suture materials
Postoperative 6th-month isthmocele rates
Active Comparator: Polyfilament Suture Group
Polyfilament sutures will be used for uterine closure.
Procedure: Uterine Closure with monofilament or polyfilament suture materials
Postoperative 6th-month isthmocele rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isthmocele Rate
Time Frame: 6 months
diagnosis of isthmocele during 6th month ultrasound check.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Collaborators

Bursa Medicana Hospital
UMI Health Center
Ceylan Hospital

Investigators

  • Study Director: Gurkan Uncu, Prof., Bursa Uludag University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-772.02-E.43598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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