Closure of Uterine Incision by Single or Double Layer Technique

NCT ID: NCT02144805

Last Updated: 2015-05-06

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

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

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The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Detailed Description

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Objective: To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Design:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.

Setting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.

Intervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.

Main outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suturing in a single layer

The technique used for single layer to close the uterine incision following cesarean sectio

Group Type ACTIVE_COMPARATOR

Suturing in a single layer

Intervention Type PROCEDURE

The procedure define the use of one single suture for closure of the uterine incision following cesarean section.

Suturing in two layer

The technique used for two layer technie to close the uterine incision following cesarean sectio

Group Type ACTIVE_COMPARATOR

Suturing in two layer

Intervention Type PROCEDURE

The procedure define the use of two sutures for closing the uterine incision following cesarean section

Interventions

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Suturing in a single layer

The procedure define the use of one single suture for closure of the uterine incision following cesarean section.

Intervention Type PROCEDURE

Suturing in two layer

The procedure define the use of two sutures for closing the uterine incision following cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women submitted to cesarean sectio
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Region Zealand

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gitte Bennich, consultant

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

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Department of Obstetrics and Gynecology

Roskilde, Roskilde, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SJ-29

Identifier Type: -

Identifier Source: org_study_id

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