Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-01-01 @ 11:52 AM
Study NCT ID:
NCT05900492
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2023-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2023-06-04', 'studyFirstSubmitQcDate': '2023-06-04', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of cesarean scar niche among cesarean deliveries', 'timeFrame': '6 months after delivery', 'description': 'number of cases develop cesarean scar niche after cesarean deliveries'}], 'secondaryOutcomes': [{'measure': 'risk factors that affect the development of the niche.', 'timeFrame': 'within 1 month of delivery', 'description': 'age- BMI- post operative infection - PROM(preterm rupture of membrane)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section', 'Dehiscence']}, 'descriptionModule': {'briefSummary': 'To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.', 'detailedDescription': 'It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:\n\nSix months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.\n\nWomen without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.\n\nFor the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include women recruited from the outpatient obstetrics clinic or emergency room after proper counseling.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Delivery by cesarean section.\n2. More than 6 months after delivery.\n3. Cesarean section by senior resident or assistant lecturer.\n\nExclusion Criteria:\n\n1. Single layer technique in uterine closure.\n2. Uterine anomaly.'}, 'identificationModule': {'nctId': 'NCT05900492', 'briefTitle': 'Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery and Assessment of Its Risk Factors', 'orgStudyIdInfo': {'id': 'cesarean scar niche R.F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'previous 1 cesarean section', 'description': 'patient who had her first Cesarean section', 'interventionNames': ['Procedure: cesarean section']}, {'label': 'previous 2 cesarean sections', 'description': 'patient who had her second Cesarean sections', 'interventionNames': ['Procedure: cesarean section']}, {'label': 'previous 3 or more cesarean sections', 'description': 'patient who had 3 or more Cesarean sections', 'interventionNames': ['Procedure: cesarean section']}], 'interventions': [{'name': 'cesarean section', 'type': 'PROCEDURE', 'description': "caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen", 'armGroupLabels': ['previous 1 cesarean section', 'previous 2 cesarean sections', 'previous 3 or more cesarean sections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62521', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Beni-suef university Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'overallOfficials': [{'name': 'sara M salem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}