Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04933032
Status:
UNKNOWN
Last Update Posted:
2021-06-21
First Post:
2021-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-08', 'releaseDate': '2024-11-18'}], 'estimatedResultsFirstSubmitDate': '2024-11-18'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-13', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-06-13', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevelance and risk factors of ceasearan section defects', 'timeFrame': 'one year', 'description': 'follow up of women underwent their section for 6 monthes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['niche , caesearan section scar defect , isthmocele'], 'conditions': ['Appropriate Diagnostic Criteria of Uterine Niche With Detection of Prevalence , Risk Factors and Associated Symptomes']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women undergoing a C-section will be asked to pariticpate in the study with follow up cases for 6 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all women underwent c-section\n\nExclusion Criteria:\n\n* known uterine anomaly\n* prior uterine surgery -prior uterine rupture\n* chronic medical disease like diabetes -use of steroid over last year regularly\n* obstetrical complications like multifetal pregnancy'}, 'identificationModule': {'nctId': 'NCT04933032', 'briefTitle': 'Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study', 'orgStudyIdInfo': {'id': 'soh-med-21-04-17'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hassan noman, dean of the faculty', 'role': 'CONTACT'}], 'facility': 'Abdelraman Fasial', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Abdelrhman faisal wasel, assistant lecturer', 'role': 'CONTACT', 'email': 'abdelrahman.faisl@med.sohag.edu.eg', 'phone': '02/01001639889'}, {'name': 'sabry mahmoud mohamed, professor', 'role': 'CONTACT', 'phone': '0100366262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of OB./GYN. sohag university hospitals', 'investigatorFullName': 'Abdelrahman Faisal Abdellattif', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-18', 'type': 'RELEASE'}, {'date': '2025-01-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Abdelrahman Faisal Abdellattif, Assistant lecturer of OB./GYN. sohag university hospitals, Sohag University'}}}}