Cesarean Scar DefectNCT03780699
Hysteroscopic Evaluation of Cesarean Scar Defect
An observational study of Cesarean Scar Defect, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Cesarean Scar Defect
- What is being tested?
- Diagnostic hysteroscopic examination
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.
Who may be able to join
- Age between 18 and 35 years.
- Had at least one prior cesarean section
Who cannot join
- History of uterine surgery that could change the cavity anatomy.
- Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
- Recent intra-uterine contraceptive device (IUCD) in place.
- Known history of endometriosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, Abbassya, 11566
Radwa R Ali, MD
About this study
Official title: Hysteroscopic Evaluation of Cesarean Scar Defect Features & Its Correlation With Women Complaints
The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.
- Conditions
- Cesarean Scar Defect
- Being tested
- Diagnostic hysteroscopic examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopic examinationProcedure or surgery
The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features
What is being measured
The primary outcome is the main question the study is designed to answer.
cesarean section scar defect shapes
different shapes of CS defect and its relation to post menstrual spotting
Measured: at least six months after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780699
- Sponsor's protocol ID
- Ain Shams University H
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Evaluation of Cesarean Scar Defect Features & Its Correlation With Women Complaints
- ClinicalTrials.gov ID
- NCT03780699
- Acronym / sponsor ID
- Ain Shams University H
- Conditions
- Cesarean Scar Defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 19 Dec 2018 (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.
The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.
Key inclusion criteria (2 listed)
- Age between 18 and 35 years.
- Had at least one prior cesarean section
Key exclusion criteria (4 listed)
- History of uterine surgery that could change the cavity anatomy.
- Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
- Recent intra-uterine contraceptive device (IUCD) in place.
- Known history of endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic hysteroscopic examinationThe hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features | Procedure or surgery | – |
Primary outcome
cesarean section scar defect shapes
Time frame: at least six months after CS
different shapes of CS defect and its relation to post menstrual spotting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: No
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Cesarean Scar Defect: a Prospective, Observational Study.
Niche
Not yet recruitingObservational study
Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Scar Defect, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa R Ali, MD (01283492979 ext. 02002, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cesarean section scar defect shapes (time frame: at least six months after CS). 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 20 Dec 2018.