Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section

NCT ID: NCT03644433

Last Updated: 2018-08-24

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2019-04-30

Brief Summary

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We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness 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 Cesarean Section Complications Cesarean Section; Complications, Wound, Dehiscence

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

Single layer closure

Group Type PLACEBO_COMPARATOR

Single layer closure

Intervention Type PROCEDURE

Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.

Double layer with resection

Double layer closure after resection uterine scar

Group Type ACTIVE_COMPARATOR

Double layer closure after resection uterine scar

Intervention Type PROCEDURE

Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.

Interventions

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Single layer closure

Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.

Intervention Type PROCEDURE

Double layer closure after resection uterine scar

Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.

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

Professor in obstetrics And gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Atatürk Üniversitesi araştırma Hastanesi

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Raşit Özler, Md

Role: CONTACT

00905465252595

ragıp a al, md

Role: CONTACT

00904423447649

Facility Contacts

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Raşit Özler, Md

Role: primary

References

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Ozler MR, Al RA. A prospective comparative study of single-layer versus double-layer uterine closure techniques on cesarean scar formation. BMC Pregnancy Childbirth. 2025 Aug 20;25(1):868. doi: 10.1186/s12884-025-08010-3.

Reference Type DERIVED
PMID: 40836292 (View on PubMed)

Other Identifiers

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B.30.2.ATA.0.01.00/4

Identifier Type: -

Identifier Source: org_study_id

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