Suture of UTerus and Ultrasound Repair Evaluation

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

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-03-31

Brief Summary

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This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

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Detailed Description

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Conditions

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Uterine Scar Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Unlocked double layer

Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium.

Group Type OTHER

Closure of the hysterotomy at the time of primary cesarean

Intervention Type PROCEDURE

Locked single layer closure

As reported in Williams Obstetrics textbook

Group Type OTHER

Closure of the hysterotomy at the time of primary cesarean

Intervention Type PROCEDURE

Locked double layer

Double layer closure with a first continuous locked suture and a second imbricating continuous suture.

Group Type OTHER

Closure of the hysterotomy at the time of primary cesarean

Intervention Type PROCEDURE

Interventions

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Closure of the hysterotomy at the time of primary cesarean

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Planned cesarean
* Primary cesarean
* ≥ 38 gestational weeks

Exclusion Criteria

* Previous cesarean
* Women \< 18 years old
* Multiple gestation
* Mullerian anomalies
* Active labor
* Diabetes
* BMI \>35 kg/m2
* Placenta praevia
* Chronic systemic disease

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes