Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-01 @ 10:55 AM
Study NCT ID:
NCT07446933
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasopressin vs. Uterine Artery Clamping for Laparoscopic Cesarean Scar Niche Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Hemoglobin Deficit Mean Hemoglobin Deficit', 'timeFrame': '24 hours post-surgery.', 'description': 'The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.'}], 'secondaryOutcomes': [{'measure': 'Surgical Field Visibility (SFV) Score', 'timeFrame': 'Intraoperative', 'description': "Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility."}, {'measure': 'Total Operative Time', 'timeFrame': 'Intraoperative', 'description': 'Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of symptomatic CSN.\n* Scheduled for laparoscopic excision and repair.\n\nExclusion Criteria:\n\n* Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease).\n* Presence of other major uterine pathologies (e.g., large myomas or malignancy).'}, 'identificationModule': {'nctId': 'NCT07446933', 'briefTitle': 'Vasopressin vs. Uterine Artery Clamping for Laparoscopic Cesarean Scar Niche Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Noninferiority of Intramyometrial Vasopressin Injection Compared to Bilateral Temporary Clamping of Uterine Arteries During Laparoscopic Excision and Repair of Cesarean Scar Niche', 'orgStudyIdInfo': {'id': 'N#3/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vasopressin Group (Group V)', 'description': 'Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision.', 'interventionNames': ['Drug: Vasopressin Group', 'Procedure: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uterine Artery Clamping Group (Group B)', 'description': 'Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision.', 'interventionNames': ['Procedure: Bulldog Clamping Group', 'Procedure: Standard of Care']}], 'interventions': [{'name': 'Vasopressin Group', 'type': 'DRUG', 'description': 'Patients receive a local injection of 12 mL of diluted vasopressin into the myometrium directly surrounding the cesarean scar niche. This is performed during the laparoscopic procedure, just before the excision of the fibrous scar tissue, to constrict local blood vessels and minimize intraoperative bleeding.', 'armGroupLabels': ['Vasopressin Group (Group V)']}, {'name': 'Bulldog Clamping Group', 'type': 'PROCEDURE', 'description': 'This intervention involves the temporary mechanical clamping of both uterine arteries using laparoscopic bulldog vascular clips. The clips are applied to block blood flow to the uterus before the niche is excised and are removed once the myometrial reconstruction is complete.', 'armGroupLabels': ['Uterine Artery Clamping Group (Group B)']}, {'name': 'Standard of Care', 'type': 'PROCEDURE', 'description': 'Approach: A 3-port laparoscopic approach using Storz endoscopic instruments.\n\nExcision: Complete removal of the fibrous scar tissue surrounding the niche defect.\n\nReconstruction: Suturing and repair of the myometrium to resolve the defect.', 'armGroupLabels': ['Uterine Artery Clamping Group (Group B)', 'Vasopressin Group (Group V)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23411', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Dr. Samir Abbas Hospital', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obestitrics and gynecology', 'investigatorFullName': 'Bassem Mohamed Talaat Abdelaziz Ali', 'investigatorAffiliation': 'Zagazig University'}}}}