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Comparison Of Suture Materials on Sectio Scars (COSMOSS)

NCT ID: NCT05096910

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Uterine Scar

Keywords

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cesarean section isthmocele uterine scar suture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Monofilament Suture Group

Monofilament sutures will be used for uterine closure.

Group Type ACTIVE_COMPARATOR

Uterine Closure with monofilament or polyfilament suture materials

Intervention Type PROCEDURE

Postoperative 6th-month isthmocele rates

Polyfilament Suture Group

Polyfilament sutures will be used for uterine closure.

Group Type ACTIVE_COMPARATOR

Uterine Closure with monofilament or polyfilament suture materials

Intervention Type PROCEDURE

Postoperative 6th-month isthmocele rates

Interventions

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Uterine Closure with monofilament or polyfilament suture materials

Postoperative 6th-month isthmocele rates

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bursa Medicana Hospital

UNKNOWN

Sponsor Role collaborator

UMI Health Center

UNKNOWN

Sponsor Role collaborator

Ceylan Hospital

UNKNOWN

Sponsor Role collaborator

Uludag University

OTHER

Sponsor Role lead

Responsible Party

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GÜRKAN UNCU,PROF. MD

M.D, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurkan Uncu, Prof.

Role: STUDY_DIRECTOR

Bursa Uludag University Faculty of Medicine

Locations

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Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kiper Aslan, M.D.

Role: CONTACT

Phone: +905548127272

Email: [email protected]

Tugba Kilik, M.D.

Role: CONTACT

Phone: +905373437012

Email: [email protected]

Facility Contacts

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GÜRKAN UNCU

Role: primary

Other Identifiers

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10840098-772.02-E.43598

Identifier Type: -

Identifier Source: org_study_id