NCT07704788

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Scar Niche

Keywords

scar niche

Outcome Measures

Primary Outcomes (1)

  • Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient

    1 hour

Study Arms (1)

scar niche patients

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Emam Mohamed Sayed Emam Mohamed Sayed

CONTACT

01095877078emammohammed.12345@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emam Mohamed Sayed

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07