Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03129035
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants needed blood transfusion', 'timeFrame': 'within 24 hours from surgery', 'description': 'number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'descriptionModule': {'briefSummary': 'All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.\n\nWomen were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention', 'detailedDescription': 'All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.\n\nWomen were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.\n\nMidline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.\n\nUsing an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with suspected placenta accreta\n* Scarred uterus\n* Approving hysterectomy\n\nExclusion Criteria:\n\n* Women needed conservative surgery\n* women with coagulopathy or bleeding disorders'}, 'identificationModule': {'nctId': 'NCT03129035', 'briefTitle': 'Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'internal iliac artery ligation', 'description': 'women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy', 'interventionNames': ['Procedure: Cesarean hystrectomy', 'Procedure: Internal iliac artery ligation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No internal iliac artery ligation', 'description': 'Women undergo cesarean hysterectomy after fetal extraction', 'interventionNames': ['Procedure: Cesarean hystrectomy']}], 'interventions': [{'name': 'Cesarean hystrectomy', 'type': 'PROCEDURE', 'description': 'Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal', 'armGroupLabels': ['No internal iliac artery ligation', 'internal iliac artery ligation']}, {'name': 'Internal iliac artery ligation', 'type': 'PROCEDURE', 'description': 'The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side', 'armGroupLabels': ['internal iliac artery ligation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}