Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

September 24, 2022 updated by: Ahmed Halouani, University Tunis El Manar

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

  1. Double layer unlocked suture;
  2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual 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)

126

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

  • Tunisia
    • La Marsa
      • Tunis, La Marsa, Tunisia, 2046
        • University hospital Mongi Slim la Marsa

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 to 48 years (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
  • Covid-19 infection

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double layer unlocked uterine closer
Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.
Procedure: Double layer closure of the hysterotomy
Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.
Experimental: Purse uterine closer
Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium
Procedure: Purse closure of the hysterotomy
Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual myometrium thickness
Time Frame: 6 months after intervention
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
scar width
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

University Tunis El Manar

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 (Actual)

May 15, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 24, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UTuniselmanar3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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