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Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section

NCT ID: NCT04198324

Last Updated: 2020-12-16

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-12-14

Brief Summary

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This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

Detailed Description

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Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

Conditions

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Cesarean Section; Dehiscence Cesarean Wound; Dehiscence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Closure of the hysterotomy at the time of primary cesarean section
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Entire fold uterine closure

The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium.

Group Type ACTIVE_COMPARATOR

Closure of the uterus with endometrium at the time of cesarean

Intervention Type PROCEDURE

Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.

Non-endometrial uterine closure

The uterus will be sewn with locked sutures that pass through myometrium without endometrium.

Group Type EXPERIMENTAL

Closure of the uterus without endometrium at the time of cesarean

Intervention Type PROCEDURE

Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

Interventions

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Closure of the uterus with endometrium at the time of cesarean

Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.

Intervention Type PROCEDURE

Closure of the uterus without endometrium at the time of cesarean

Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Term pregnancy (≥37 weeks of gestation)
* Singleton pregnancy
* Primary cesarean

Exclusion Criteria

* Previous cesarean section
* Previous uterine surgery
* Multiple gestations
* Mullerian anomalies
* Active labor
* Placenta previa/accreta
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Şener Gezer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şener Gezer, M.D

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.

Reference Type BACKGROUND
PMID: 23996650 (View on PubMed)

Other Identifiers

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KIA 2019/94

Identifier Type: -

Identifier Source: org_study_id