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

NCT07074522 | Completed

• 1 other identifier: 36264MS426/11/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transvaginal Ultrasound; Caesarean Section; Uterine Scar; Single Layer; Double Layer

Outcome Measures

Primary Outcomes (1)

• Uterine scar thickness

  Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.

  6 months postoperatively

Study Arms (2)

Single layer group

EXPERIMENTAL

Patients who underwent single-layer closure of the transverse lower segment during cesarean section.

Procedure: Single-layer closure

Double layer group

EXPERIMENTAL

Patients who underwent double-layer closure of the transverse lower segment during cesarean section.

Procedure: Double-layer closure

Interventions

Single-layer closure PROCEDURE

Patients who underwent single-layer closure of the transverse lower segment during cesarean section.

Single layer group

Double-layer closure PROCEDURE

Patients who underwent double-layer closure of the transverse lower segment during cesarean section.

Double layer group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant women underwent their first cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: December 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)