Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-08 @ 12:31 AM
Study NCT ID:
NCT02177994
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis for Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007262', 'term': 'Infusions, Intravenous'}], 'ancestors': [{'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the rate of post cesarean section surgical site infection.', 'timeFrame': 'administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days', 'description': 'postoperative assessment of SSI. Patients will be followed up at 48-72 hours postoperative, at 7th days (skin suture removal) and at 6 weeks (contraception application).all patients will be contacted by telephone and interviewed. They will be rescheduled for a clinic visit if they reported signs and symptoms of wound infection (purulent discharge or erythema \\>1 cm in diameter, induration of the incision site and fever).'}], 'secondaryOutcomes': [{'measure': 'other post cesarean section maternal and neonatal infection', 'timeFrame': 'follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery', 'description': '1. Maternal complications: other post cesarean section maternal complications, namely endometritis, pyrexia, urinary tract infection and complication of drug administration such as anaphylaxis.\n2. Neonatal complications: such as neonatal sepsis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elective Cesarean Section', 'Antibiotic prophylaxis', 'Timing of Antibiotic prophylaxis', 'post cesarean section infection'], 'conditions': ['Infection of Cesarian Section Wound Following Delivery']}, 'descriptionModule': {'briefSummary': 'A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.', 'detailedDescription': 'comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective cesarean section with Gestational age 37 weeks or more\n\nExclusion Criteria:\n\n1. Fever greater than 38°C or maternal sepsis.\n2. Cephalosporin allergy.\n3. Exposure to any antibiotic agent within 1week before delivery.\n4. Patents having premature rupture of membranes and acute chorioamnionitis.\n5. Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).\n\n3\\) Morbid obesity (BMI\\>30)'}, 'identificationModule': {'nctId': 'NCT02177994', 'acronym': 'TOAPFECSACT', 'briefTitle': 'Antibiotic Prophylaxis for Elective Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TOAPFECSACT'}, 'secondaryIdInfos': [{'id': 'AinShamsMH', 'type': 'OTHER', 'domain': 'AinShamsMH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A ceftriaxone after cord clamping', 'description': '165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive\n\n1 gm. ceftriaxone via l intravenous infusion single dose after cord clamping.', 'interventionNames': ['Drug: ceftriaxone 1gm for intravenous infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B ceftriaxone before skin incision', 'description': '165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive\n\n1 gm. ceftriaxone vial intravenous infusion single dose 30-60 minutes before skin incision.', 'interventionNames': ['Drug: ceftriaxone 1gm for intravenous infusion']}], 'interventions': [{'name': 'ceftriaxone 1gm for intravenous infusion', 'type': 'DRUG', 'otherNames': ['cefaxon'], 'description': 'Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)', 'armGroupLabels': ['Group A ceftriaxone after cord clamping', 'Group B ceftriaxone before skin incision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+20', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Antibiotic Prophylaxis for Elective Cesarean Section', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amr AH Helmy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams Maternity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in OB GYN', 'investigatorFullName': 'AMR HELMY YEHIA', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}