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Completed

NCT Number: NCT07074522

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

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.

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Key information

Conditions

Transvaginal Ultrasound Caesarean Section Double Layer Single Layer Uterine Scar

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-layer closure

Procedure

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

Double-layer closure

Procedure

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

Primary outcomes

  1. Uterine scar thickness

    Time frame: 6 months postoperatively

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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