Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT06493968
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'during operation', 'description': 'amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'during operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta Spectrum']}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy of singleton living fetus\n* Previous one or more cesarean sections\n* Gestational age: \\> 32 weeks\n* The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".\n* Preoperative hemoglobin more than 10 gm/dl\n* Cases with PAS that will undergoing CS Hysterectomy\n\nExclusion Criteria:\n\n* Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.….\n* Any known or reported hypersensitivity to the used medication.\n* All cases with spontaneous placental separation at laparotomy.\n* All patients undergoing conservative management of PAS.\n* All cases which necessitate emergency termination.'}, 'identificationModule': {'nctId': 'NCT06493968', 'briefTitle': 'Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accrete Spectrum Disorders Undergoing Cesarean Hysterectomy', 'orgStudyIdInfo': {'id': 'Uterotonics in PASD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'Patients will be given uterotonics', 'interventionNames': ['Drug: oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group (B)', 'description': 'Patients will not be given uterotonics', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'description': 'Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision', 'armGroupLabels': ['Group (A)']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'IV bolus of normal saline immediately with the uterine incision', 'armGroupLabels': ['Group (B)']}]}, '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}}], 'centralContacts': [{'name': 'Abdalla Mousa', 'role': 'CONTACT', 'email': 'Dr_abdallamousa@yahoo.com', 'phone': '+201277664430'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obgyn Cairo university', 'investigatorFullName': 'Abdalla Mousa', 'investigatorAffiliation': 'Cairo University'}}}}