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NCT Number: NCT07704788

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

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 hour

Study contacts

Contact information is provided by the study sponsor or research team.

Emam Mohamed Sayed Emam Mohamed Sayed

CONTACT

[email protected]

01095877078

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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