- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04933032
Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
June 13, 2021 updated by: Abdelrahman Faisal Abdellattif, Sohag University
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 Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abdelrhman faisal wasel, assistant lecturer
- Phone Number: 02/01001639889
- Email: abdelrahman.faisl@med.sohag.edu.eg
Study Contact Backup
- Name: sabry mahmoud mohamed, professor
- Phone Number: 0100366262
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Abdelraman Fasial
-
Contact:
- hassan noman, dean of the faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
All women undergoing a C-section will be asked to pariticpate in the study with follow up cases for 6 months
Description
Inclusion Criteria:
- all women underwent c-section
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevelance and risk factors of ceasearan section defects
Time Frame: one year
|
follow up of women underwent their section for 6 monthes
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
June 13, 2021
First Submitted That Met QC Criteria
June 13, 2021
First Posted (Actual)
June 21, 2021
Study Record Updates
Last Update Posted (Actual)
June 21, 2021
Last Update Submitted That Met QC Criteria
June 13, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- soh-med-21-04-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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