Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03556267
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2018-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Anesthesia of Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2018-05-19', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSF sample: serum sample', 'timeFrame': 'One year', 'description': 'After insertion of an intravenous line 4 ml serum will be collected, then 0.5 ml CSF sample will be collected after insertion of the dura by the selected spinal needle before injecting the anesthetic drugs used for spinal anesthesia. Beta trace protein assay will be measured through ELISA technique in both CSF and serum samples and the ratio will be calculated and measured. This ratio will be measured for the three arms aiming at the comparison between the three devices regarding the CSF : Serum ratio.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Obestetric']}, 'descriptionModule': {'briefSummary': 'Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.', 'detailedDescription': 'Beta trace protein is specific for CSF only and it is a quantitative analytic test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old\n* free medical history.\n* free obstetric history.\n\nExclusion Criteria:\n\n* high risk pregnancy.'}, 'identificationModule': {'nctId': 'NCT03556267', 'briefTitle': 'Regional Anesthesia of Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section', 'orgStudyIdInfo': {'id': 'ATC 2030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'spinal needle 27 gauqge', 'description': 'It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.', 'interventionNames': ['Device: spinal needle']}, {'type': 'OTHER', 'label': 'spinal needle 25 gauage', 'description': 'It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.', 'interventionNames': ['Device: spinal needle']}], 'interventions': [{'name': 'spinal needle', 'type': 'DEVICE', 'description': "It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.", 'armGroupLabels': ['spinal needle 25 gauage', 'spinal needle 27 gauqge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Abdelrahman', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reham Ali Abdelhaleem Abdelrahman', 'investigatorAffiliation': 'Cairo University'}}}}