Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

NCT ID: NCT03915847

Last Updated: 2020-05-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2020-04-16

Brief Summary

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The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

Detailed Description

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Conditions

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Cesarean Section, Repeated Cesarean, Uterine Scar Thickness Cesarean, Residual Myometrial Thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Single layer closure

Group Type ACTIVE_COMPARATOR

Single layer closure

Intervention Type PROCEDURE

Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.

Double layer closure

Group Type ACTIVE_COMPARATOR

Double layer closure

Intervention Type PROCEDURE

The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Doble layer closure with trimming

Group Type ACTIVE_COMPARATOR

Doble layer closure with trimming

Intervention Type PROCEDURE

Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Interventions

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Single layer closure

Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.

Intervention Type PROCEDURE

Double layer closure

The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Intervention Type PROCEDURE

Doble layer closure with trimming

Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Previous two or three cesarean
* Gestational weeks \>=36 weeks

Exclusion Criteria

* Risk of obstetric haemorrhage
* Suspicion or diagnosis placenta previa or accrete syndrome
* Chorioamnionitis
* Uterine myoma in the anterior uterine segment
* Hysterotomy other than lower segment uterine incision at previous cesarean
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ragıp Atakan Al

Proffesor in dept. of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University Hospital

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ATA35

Identifier Type: -

Identifier Source: org_study_id

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