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CompletedNCT07074522Updated Jul 20, 2025

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

An interventional study of Single-layer closure and Double-layer closure in Transvaginal Ultrasound, Caesarean Section and Uterine Scar, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Dec 2023, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Transvaginal Ultrasound
  • Caesarean Section
  • Uterine Scar
  • Single Layer
  • Double Layer
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Single layer group

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

    Procedure: Single-layer closure

  • Experimental
    Double layer group

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

    Procedure: Double-layer closure

Interventions

  • ProcedureSingle-layer closure

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

  • ProcedureDouble-layer closure

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

06

What researchers measure

Primary outcomes

  1. Uterine scar thickness

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

    Time frame: 6 months postoperatively

07

Study locations

1 site
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07074522
Lead sponsor
Tanta University
Responsible party
Said Abd El Kareem Said Saad (Resident of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Jul 20, 2025
Start date
Dec 1, 2023
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024
Last update
Jul 20, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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