Scar NicheNCT07704788
Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS
An observational study of Scar Niche, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Scar Niche
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scar Niche
- Keywords
- scar niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| scar niche patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar NicheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emam Mohamed Sayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704788
- Sponsor's protocol ID
- Soh-Med-26-6-22MS
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS for the Evaluation of Cesarean Scar Defect
- ClinicalTrials.gov ID
- NCT07704788
- Acronym / sponsor ID
- Soh-Med-26-6-22MS
- Conditions
- Scar Niche
- Keywords
- scar niche
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scar niche patients | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Scar Niche
Not yet recruitingObservational study
The Relationship Between the Number of Ceserean Sections and Scar Niche Development
Scar Niche, Infertility, Post Menstrual Spotting
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
Caesarean Scar Niche
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Scar Niche, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emam Mohamed Sayed Emam Mohamed Sayed (01095877078, emammohammed.12345@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.