Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 5:41 AM
Study NCT ID:
NCT06185894
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-01', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative quantified blood loss', 'timeFrame': 'during operation', 'description': 'Quantified blood loss estimate with the tourniquet'}], 'secondaryOutcomes': [{'measure': 'amount of blood and blood product transfusion', 'timeFrame': 'during operation and 48 hours post operative', 'description': 'amount of blood and blood product transfusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'referencesModule': {'references': [{'pmid': '41387818', 'type': 'DERIVED', 'citation': 'Mousa A, Gaafar HM, Abdullah M, Elsherbini MM, Abdel-Rasheed M, Rida D, Saysaneh A, Collins SL, Abdelbar A. Uterovesical tourniquet for conservative management of placenta accreta spectrum: a prospective cohort study in a low-resource setting. BMC Pregnancy Childbirth. 2025 Dec 12. doi: 10.1186/s12884-025-08381-7. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.\n\nObjective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.\n\nPatients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females with previous CS deliveries (at least 1).\n* Patients with ultrasound criteria of placenta accerta spectrum.\n* Patients desiring fertility (uterine conservation).\n* Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.\n\nExclusion Criteria:\n\n* Maternal age above 40 years.\n* Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).\n* Patients presented with severe antepartum hemorrhage (unstable vital signs).\n* Patients requested radical management (caesarean hysterectomy).'}, 'identificationModule': {'nctId': 'NCT06185894', 'acronym': 'SPARTACUS', 'briefTitle': 'Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study', 'orgStudyIdInfo': {'id': 'Ms-105-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'conservation without the use of a tourniquet', 'description': 'surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet', 'interventionNames': ['Procedure: Conventional conservative surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conservation with the use of a tourniquet', 'description': 'surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction', 'interventionNames': ['Procedure: Uterovesical tourniquet before uterine devascularization steps']}], 'interventions': [{'name': 'Uterovesical tourniquet before uterine devascularization steps', 'type': 'PROCEDURE', 'otherNames': ['Uterine Pringles maneuver'], 'description': 'Insertion of a Foley catheter tourniquet through broad ligament apertures \\& tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum', 'armGroupLabels': ['conservation with the use of a tourniquet']}, {'name': 'Conventional conservative surgery', 'type': 'PROCEDURE', 'description': 'Conventional conservative surgery', 'armGroupLabels': ['conservation without the use of a tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdalla Mousa', 'role': 'CONTACT', 'email': 'Dr_abdallamousa@yahoo.com', 'phone': '+201277664430'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obgyn Cairo university', 'investigatorFullName': 'Abdalla Mousa', 'investigatorAffiliation': 'Cairo University'}}}}