Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
| Sponsors |
Lead Sponsor: Assiut University Collaborator: Yasser Esmat Mohammed |
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| Source | Assiut University |
| Brief Summary | Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care |
| Detailed Description | This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section. Outcomes will include fever, wound infection, and urinary tract infection. |
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| Overall Status | Recruiting | ||||
| Start Date | 2019-07-01 | ||||
| Completion Date | 2020-03-01 | ||||
| Primary Completion Date | 2020-02-01 | ||||
| Phase | Phase 2/Phase 3 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 500 |
| Condition | |
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| Intervention |
Intervention Type: Drug Intervention Name: Cefepime Description: Antibiotic prophylaxis Arm Group Label: "Cefepime" , "Maxipime®" 1 gm Other Name: Maxipime Intervention Type: Drug Intervention Name: Cefuroxime plus Metronidazole Description: Antibiotic prophylaxis Arm Group Label: "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500 Other Name: Zinnat plus Flagyl |
| Eligibility |
Criteria:
Inclusion Criteria: - intrapartum caesarean section Exclusion Criteria: - evidence of infection Gender: Female Minimum Age: 20 Years Maximum Age: 40 Years Healthy Volunteers: Accepts Healthy Volunteers |
| Overall Contact |
Last Name: Abdalmageed Abdalmageed Phone: +201007972027 Email: [email protected] |
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| Location |
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| Location Countries |
Egypt |
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| Verification Date |
2019-07-01 |
| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Assiut University Investigator Full Name: Osama Saber Thabet Abdalmageed Investigator Title: Consultant of Obstetrics and gynecology |
| Keywords | |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 2 |
| Arm Group |
Label: "Cefepime" , "Maxipime®" 1 gm Type: Active Comparator Description: Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision Label: "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500 Type: Active Comparator Description: Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section |
| Patient Data | No |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Double (Participant, Investigator) |