Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-03 @ 1:55 PM
Study NCT ID:
NCT06048692
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077723', 'term': 'Cefepime'}, {'id': 'C035444', 'term': 'sultamicillin'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-16', 'studyFirstSubmitDate': '2023-09-16', 'studyFirstSubmitQcDate': '2023-09-16', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '1 month', 'description': 'pain, redness, swelling, warm skin around the wound, yellow or green discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical site infection', 'Cefepime'], 'conditions': ['Cesarean Section; Infection']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.', 'detailedDescription': 'A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women within age group more than18 years.\n* Pregnant women with elective cesarean delivery.\n* Previous and primary cesarean delivery.\n\nExclusion Criteria:\n\nSevere hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.\n\nWomen who had a skin infection adjacent to the operative site.'}, 'identificationModule': {'nctId': 'NCT06048692', 'briefTitle': 'Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections', 'orgStudyIdInfo': {'id': 'maxipime in cs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefepime Group', 'description': 'Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD', 'interventionNames': ['Drug: Cefepime 1000 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ampicillin/Sulbactam', 'description': 'Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD', 'interventionNames': ['Drug: Ampicillin-sulbactam']}], 'interventions': [{'name': 'Cefepime 1000 MG', 'type': 'DRUG', 'otherNames': ['maxipime'], 'description': 'Cefepime is a fourth-generation cephalosporin antibiotic', 'armGroupLabels': ['Cefepime Group']}, {'name': 'Ampicillin-sulbactam', 'type': 'DRUG', 'otherNames': ['unictam'], 'description': 'Broad-Spectrum Antibiotic', 'armGroupLabels': ['Ampicillin/Sulbactam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62521', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Beni-suef university Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'overallOfficials': [{'name': 'Beni-Suef University', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}