Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Scar Niche. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS for the Evaluation of Cesarean Scar Defect
Overview
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.
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.
Primary outcome measures
- Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient [Time frame: 1 hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07704788 · Soh-Med-26-6-22MS