Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS

Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS for the Evaluation of Cesarean Scar Defect

Primary aim:

To assess the diagnostic agreement between 2D vs 3D TV U/S with or without SIS for the evaluation of cesarean scar defects and its correlation with symptoms.

Secondary aims:

To assess the relation between the size of the niche and the patient symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Scar Niche

Detailed Description

Primary aim:

To assess the diagnostic agreement between 2D vs 3D TV U/S with or without SIS for the evaluation of cesarean scar defects and its correlation with symptoms. To compare both imaging modalities regarding assessment of cesarean scar defect parameters, including depth, length, width, anterior myometrial thickness, and residual myometrial thickness, as well as to evaluate procedure time, patient tolerability, and satisfaction.

Secondary aims:

To assess the relation between the size of the niche and the patient symptoms.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Emam Mohamed Sayed Emam Mohamed Sayed; Phone Number: 01095877078; Email: emammohammed.12345@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women aged 20-45 years History of at least one previous cesarean section Interval since last cesarean section ranging from 6 months to 10 years Willingness to participate and provide written informed consent

Description

Inclusion criteria:

• Women aged 20-45 years
• History of at least one previous cesarean section
• Interval since last cesarean section ranging from 6 months to 10 years
• Willingness to participate and provide written informed consent

Exclusion criteria:

• Current pregnancy
• Active pelvic infection or acute pelvic inflammatory disease
• Large uterine fibroids distorting the uterine cavity
• History of uterine surgery other than cesarean section (e.g., myomectomy)
• Failure of SIS performance
• Patients on any contraception methods

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
scar niche patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient	1 hour

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: scar niche
• Other Study ID Numbers: Soh-Med-26-6-22MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No