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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04009772
Collaborator
Yasser Esmat Mohammed (Other)
500
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
62.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
Actual Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: "Cefepime" , "Maxipime®" 1 gm

Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision

Drug: Cefepime
Antibiotic prophylaxis
Other Names:
  • Maxipime

    		•
    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

    Drug: Cefuroxime plus Metronidazole
    Antibiotic prophylaxis
    Other Names:
  • Zinnat plus Flagyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of surgical site wound infection [one week]

      Examining the wound after one week of the surgery to detect any infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • intrapartum caesarean section
    Exclusion Criteria:
    • evidence of infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University
    • Yasser Esmat Mohammed

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osama Saber Thabet Abdalmageed, Consultant of Obstetrics and gynecology, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04009772
    Other Study ID Numbers:
    • Antibiotic CS
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Osama Saber Thabet Abdalmageed, Consultant of Obstetrics and gynecology, Assiut University
    Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum
    Additional relevant MeSH terms:
    Emergencies
    Metronidazole
    Cefuroxime
    Cefuroxime axetil
    Cefepime

    Study Results

    No Results Posted as of Jul 5, 2019