Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT04518150
Status:
UNKNOWN
Last Update Posted:
2020-09-21
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blind randomized controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-08-15', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean Blood loss after placental separation', 'timeFrame': '30 minutes', 'description': 'by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set'}], 'secondaryOutcomes': [{'measure': 'The number of participant needed for blood transfusion', 'timeFrame': '24 hours', 'description': 'Calculation of the number of participant needed for blood transfusion'}, {'measure': 'Number of Participants with postpartum hemorrhage', 'timeFrame': '24 hours', 'description': 'number pf participants with blood loss \\> 1000ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa', 'detailedDescription': 'Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures\n\nExclusion Criteria:\n\n* patients with the high possibility of morbid adherent placenta\n* those presented with severe antepartum hemorrhage\n* Patients with cardiac, hepatic, renal, or thromboembolic disease;\n* patient refuses to consent'}, 'identificationModule': {'nctId': 'NCT04518150', 'briefTitle': 'Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/270/9/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon', 'interventionNames': ['Device: Bakri balloon', 'Procedure: Bilateral Uterine Artery Ligation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon', 'interventionNames': ['Device: Bakri balloon']}], 'interventions': [{'name': 'Bakri balloon', 'type': 'DEVICE', 'otherNames': ['BBT'], 'description': 'the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally', 'armGroupLabels': ['control group', 'study group']}, {'name': 'Bilateral Uterine Artery Ligation', 'type': 'PROCEDURE', 'otherNames': ['BUAL'], 'description': 'The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hany F Sallam, MD', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '0122336052', 'phoneExt': '002'}, {'name': 'Nahla W Shady, MD', 'role': 'CONTACT', 'email': 'nahla.elsayed@aswu.edu.eg', 'phone': '01092440504', 'phoneExt': '002'}], 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f Sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '+20102435461', 'phoneExt': '002'}, {'name': 'nahla w Shady, md', 'role': 'CONTACT', 'email': 'hanygyne@yahoo.com', 'phone': '+201022336052', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'nahla w Shady, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Aswan universirty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}