Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01723605
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2012-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insitu Repair Versus Uterine Exeriorization During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-28', 'studyFirstSubmitDate': '2012-11-04', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel movement', 'timeFrame': '12 hours', 'description': 'Regain of bowel movement'}], 'secondaryOutcomes': [{'measure': 'Surgery duration', 'timeFrame': '2 hours', 'description': 'The duration of intraoperative surgey'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['insitu repair', 'intestinal motility'], 'conditions': ['Complications; Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '25005057', 'type': 'DERIVED', 'citation': 'El-Khayat W, Elsharkawi M, Hassan A. A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery. Int J Gynaecol Obstet. 2014 Nov;127(2):163-6. doi: 10.1016/j.ijgo.2014.05.004. Epub 2014 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.', 'detailedDescription': 'Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n\nExclusion Criteria:\n\n* liver disease\n* kidney disease\n* bleeding tendency\n* abnormal placentation\n* preeclampsia'}, 'identificationModule': {'nctId': 'NCT01723605', 'briefTitle': 'Insitu Repair Versus Uterine Exeriorization During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '32012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insitu repair', 'description': 'insitu repair of the uterine incision during caeserean section', 'interventionNames': ['Procedure: insitu repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'exteriorisation of the uretus', 'description': 'uterine closure during caeserian section with exteriorisation of the uterus', 'interventionNames': ['Procedure: exteriorisation of the uterus']}], 'interventions': [{'name': 'insitu repair', 'type': 'PROCEDURE', 'otherNames': ['repair insitu'], 'description': 'closure of the uterine incision while the uterus initu', 'armGroupLabels': ['insitu repair']}, {'name': 'exteriorisation of the uterus', 'type': 'PROCEDURE', 'otherNames': ['uterine closure with exteriorisation of the uterus'], 'description': 'uterine closure while the uterus is exteriorised', 'armGroupLabels': ['exteriorisation of the uretus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Waleed El-khayat', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor', 'investigatorFullName': 'Waleed El-khayat', 'investigatorAffiliation': 'Cairo University'}}}}