Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section

Overview

Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

Full Title of Study: “Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 1, 2020

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.

Interventions

  • Drug: Cefepime
    • Antibiotic prophylaxis
  • Drug: Cefuroxime plus Metronidazole
    • Antibiotic prophylaxis

Arms, Groups and Cohorts

  • Active Comparator: “Cefepime” , “Maxipime®” 1 gm
    • Patient will receive “Cefepime” ,”Maxipime®” 1 gm IV during cesarean section just before skin incision
  • Active Comparator: “Cefuroxime”, “Zinnat®” 1gm plus “metronidazole”Flagyl®” 500
    • Patient will receive “Cefuroxime”, “Zinnat®” 1gm ,and “metronidazole”Flagyl®” 500 IV; just before skin incision for emergency cesarean section

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of surgical site wound infection
    • Time Frame: one week
    • Examining the wound after one week of the surgery to detect any infection

Participating in This Clinical Trial

Inclusion Criteria

  • intrapartum caesarean section

Exclusion Criteria

  • evidence of infection

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Collaborator
    • Yasser Esmat Mohammed
  • Provider of Information About this Clinical Study
    • Principal Investigator: Osama Saber Thabet Abdalmageed, Consultant of Obstetrics and gynecology – Assiut University
  • Overall Contact(s)
    • Abdalmageed Abdalmageed, +201007972027, drosamast@yahoo.com.au

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