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

Primary Purpose

Uterine Scar

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Uterine Closure with monofilament or polyfilament suture materials

About this trial

This is an interventional diagnostic trial for Uterine Scar focused on measuring cesarean section, isthmocele, uterine scar, suture

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Uludag University Scholl of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Monofilament Suture Group

Polyfilament Suture Group

Arm Description

Monofilament sutures will be used for uterine closure.

Polyfilament sutures will be used for uterine closure.

Outcomes

Primary Outcome Measures

Isthmocele Rate

diagnosis of isthmocele during 6th month ultrasound check.

Secondary Outcome Measures

Full Information

NCT ID

NCT05096910

First Posted

October 14, 2021

Last Updated

October 26, 2021

Sponsor

Uludag University

Collaborators

Bursa Medicana Hospital, UMI Health Center, Ceylan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05096910

Brief Title

Comparison Of Suture Materials on Sectio Scars (COSMOSS)

Acronym

COSMOSS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2020 (Actual)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uludag University

Collaborators

Bursa Medicana Hospital, UMI Health Center, Ceylan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Scar

Keywords

cesarean section, isthmocele, uterine scar, suture

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Monofilament Suture Group

Arm Type

Active Comparator

Arm Description

Monofilament sutures will be used for uterine closure.

Arm Title

Polyfilament Suture Group

Arm Type

Active Comparator

Arm Description

Polyfilament sutures will be used for uterine closure.

Intervention Type

Procedure

Intervention Name(s)

Uterine Closure with monofilament or polyfilament suture materials

Intervention Description

Postoperative 6th-month isthmocele rates

Primary Outcome Measure Information:

Title

Isthmocele Rate

Description

diagnosis of isthmocele during 6th month ultrasound check.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kiper Aslan, M.D.

Phone

+905548127272

kiperaslan@yahoo.com.tr

First Name & Middle Initial & Last Name or Official Title & Degree

Tugba Kilik, M.D.

Phone

+905373437012

tbsklk@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gurkan Uncu, Prof.

Organizational Affiliation

Bursa Uludag University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Uludag University Scholl of medicine

City

Bursa

State/Province

Turkey/bursa

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

GÜRKAN UNCU

Phone

0224 2952541

guncu@gurkanuncu.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Comparison Of Suture Materials on Sectio Scars (COSMOSS)

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