Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01347593
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2011-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-04-15', 'releaseDate': '2013-03-05'}, {'resetDate': '2013-05-29', 'releaseDate': '2013-04-22'}], 'estimatedResultsFirstSubmitDate': '2013-03-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D015296', 'term': 'Ceftizoxime'}], 'ancestors': [{'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reducing post Cesarean section febrile morbidity', 'timeFrame': '4 days', 'description': 'reducing infection rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ceftizoxime', 'Cesarean', 'post caesarean febrile morbidity'], 'conditions': ['Caesarean']}, 'referencesModule': {'references': [{'pmid': '23394621', 'type': 'DERIVED', 'citation': 'Osman B, Abbas A, Ahmed MA, Abubaker MS, Adam I. Prophylactic ceftizoxime for elective cesarean delivery at Soba Hospital, Sudan. BMC Res Notes. 2013 Feb 8;6:57. doi: 10.1186/1756-0500-6-57.'}]}, 'descriptionModule': {'briefSummary': 'Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective Cesarean section\n\nExclusion Criteria:\n\n* Diabetes severe anaemia allergy'}, 'identificationModule': {'nctId': 'NCT01347593', 'briefTitle': 'Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Khartoum'}, 'officialTitle': 'Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan', 'orgStudyIdInfo': {'id': 'ceftizoxime cesarean'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ceftizoxime (cefizox) injection', 'description': 'ceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision', 'interventionNames': ['Drug: ceftizoxime']}], 'interventions': [{'name': 'ceftizoxime', 'type': 'DRUG', 'otherNames': ['cefizox'], 'description': 'ceftizoxime (cefizox) injection either after clamping the cord', 'armGroupLabels': ['ceftizoxime (cefizox) injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '249', 'city': 'Khartoum', 'state': 'Khartoum State', 'country': 'Sudan', 'facility': 'Soba Hospital', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Khartoum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Sudan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ishag Adam', 'investigatorAffiliation': 'University of Khartoum'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-03-05', 'type': 'RELEASE'}, {'date': '2013-04-15', 'type': 'RESET'}, {'date': '2013-04-22', 'type': 'RELEASE'}, {'date': '2013-05-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ishag Adam, Professor, University of Khartoum'}}}}