Suture of UTerus and Ultrasound Repair Evaluation (SUTURE)

May 14, 2015 updated by: Emmanuel Bujold, CHU de Quebec-Universite Laval

Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G2
        • Chu De Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: Closure of the hysterotomy at the time of primary cesarean
Other: Locked single layer closure
As reported in Williams Obstetrics textbook
Procedure: Closure of the hysterotomy at the time of primary cesarean
Other: Locked double layer
Double layer closure with a first continuous locked suture and a second imbricating continuous suture.
Procedure: Closure of the hysterotomy at the time of primary cesarean

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean myometrium thickness
Time Frame: 6 months after intervention
Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.
6 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated blood loss
Time Frame: Same day of intervention: day 1
Same day of intervention: day 1
Operative time
Time Frame: Same day of intervention: day 1
Same day of intervention: day 1
Mean number of haemostatic sutures
Time Frame: Same day of intervention: day 1
Same day of intervention: day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Laval University
Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C12-03-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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