Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT02728232
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal Iliac Artery Ligation and Abnormally Invasive Placenta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-14', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of intra-operative hemorrhage', 'timeFrame': '2-3 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Placenta Percreta']}, 'descriptionModule': {'briefSummary': 'This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females with pre-operative diagnosis of abnormally invasive placenta\n\nExclusion Criteria:\n\n* refusal to get enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02728232', 'briefTitle': 'Internal Iliac Artery Ligation and Abnormally Invasive Placenta', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'orgStudyIdInfo': {'id': 'PP2302019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internal Iliac artery ligation group', 'description': 'in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure', 'interventionNames': ['Procedure: internal iliac artery ligation', 'Procedure: Cesarean Hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hysterectomy only', 'description': 'in this group patients will undergo cesarean hysterectomy only', 'interventionNames': ['Procedure: Cesarean Hysterectomy']}], 'interventions': [{'name': 'internal iliac artery ligation', 'type': 'PROCEDURE', 'armGroupLabels': ['Internal Iliac artery ligation group']}, {'name': 'Cesarean Hysterectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Hysterectomy only', 'Internal Iliac artery ligation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Ahmed Mahmoud Hussein', 'investigatorAffiliation': 'Cairo University'}}}}