Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated SymptomesNCT04933032
Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
An observational study of Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes, run by Sohag University at 1 site in Egypt.
Trial summary
The primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(CSSD) once the appropriate diagnostic criteria are established the natural history of CSSD could be elucidated through exploration of the prevelance ,risk factors… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to Mar 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women undergoing a C-section will be asked to pariticpate in the study with follow up cases for 6 months
Who may be able to join
- all women underwent c-section
Who cannot join
- known uterine anomaly
- prior uterine surgery -prior uterine rupture
- chronic medical disease like diabetes -use of steroid over last year regularly
- obstetrical complications like multifetal pregnancy
Trial locations and contacts
1 site in 1 country.
sabry mahmoud mohamed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Abdelraman Fasial
Sohag
hassan noman, dean of the faculty
About this study
The primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(CSSD) once the appropriate diagnostic criteria are established the natural history of CSSD could be elucidated through exploration of the prevelance ,risk factors, and associated symptomes of the disease
- Keywords
- niche , caesearan section scar defect , isthmocele
What is being measured
The primary outcome is the main question the study is designed to answer.
prevelance and risk factors of ceasearan section defects
follow up of women underwent their section for 6 monthes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jun 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated SymptomesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Faisal Abdellattif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933032
- Sponsor's protocol ID
- soh-med-21-04-17
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Jun 2021
- 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
- ClinicalTrials.gov ID
- NCT04933032
- Acronym / sponsor ID
- soh-med-21-04-17
- Keywords
- niche , caesearan section scar defect , isthmocele
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 21 Jun 2021 (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 primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(CSSD) once the appropriate diagnostic criteria are established the natural history of CSSD could be elucidated through exploration of the prevelance ,risk factors, and associated symptomes of the disease
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women undergoing a C-section will be asked to pariticpate in the study with follow up cases for 6 months
Key inclusion criteria (1 listed)
- all women underwent c-section
Key exclusion criteria (4 listed)
- known uterine anomaly
- prior uterine surgery -prior uterine rupture
- chronic medical disease like diabetes -use of steroid over last year regularly
- obstetrical complications like multifetal pregnancy
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
prevelance and risk factors of ceasearan section defects
Time frame: one year
follow up of women underwent their section for 6 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
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.
sabry mahmoud mohamed, professor contact
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 Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes, run by Sohag 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 1 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 21 Jun 2021. 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 Abdelrhman faisal wasel, assistant lecturer (02/01001639889, abdelrahman.faisl@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevelance and risk factors of ceasearan section defects (time frame: one year). 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 21 Jun 2021.