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

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.

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
Measure Time Frame
Incidence of surgical site wound infection one week
Enrollment 500
Condition
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]

Location
Facility: Status: Contact: Assiut University Abdalmageed 1007972027 [email protected]
Location Countries

Egypt

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)

Source: ClinicalTrials.gov

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