Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer

July 10, 2025 updated by: Said Abd El Kareem Said Saad, Tanta University
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.

Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.

Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 20 to 40 years old.
  • Pregnant women underwent their first cesarean section.

Exclusion Criteria:

  • Body mass index (BMI) ≥ 30 kg /m2.
  • Multiple gestations.
  • Uterine malformation.
  • Placenta previa.
  • Placenta accreta.
  • Uterine or cervical fibroid.
  • Any previous uterine operation or any medical disease that compromises wound healing, such as diabetes mellitus, collagen diseases, anemia, or corticosteroid therapy.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single layer group
Patients who underwent single-layer closure of the transverse lower segment during cesarean section.
Procedure: Single-layer closure
Patients who underwent single-layer closure of the transverse lower segment during cesarean section.
Experimental: Double layer group
Patients who underwent double-layer closure of the transverse lower segment during cesarean section.
Procedure: Double-layer closure
Patients who underwent double-layer closure of the transverse lower segment during cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine scar thickness
Time Frame: 6 months postoperatively
Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.
6 months postoperatively

Collaborators and Investigators

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

Sponsor

Tanta University

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)

December 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 36264MS426/11/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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