search
Back to results

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

Primary Purpose

Emergency Cesarean Section, Infection Wound

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cefepime
Cefuroxime plus Metronidazole
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergency Cesarean Section focused on measuring Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • intrapartum caesarean section

Exclusion Criteria:

  • evidence of infection

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

"Cefepime" , "Maxipime®" 1 gm

"Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500

Arm Description

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

Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2019
Last Updated
July 3, 2019
Sponsor
Assiut University
Collaborators
Yasser Esmat Mohammed
search

1. Study Identification

Unique Protocol Identification Number
NCT04009772
Brief Title
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
Official Title
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Yasser Esmat Mohammed

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Cesarean Section, Infection Wound
Keywords
Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Cefepime" , "Maxipime®" 1 gm
Arm Type
Active Comparator
Arm Description
Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision
Arm Title
"Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500
Arm Type
Active Comparator
Arm Description
Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section
Intervention Type
Drug
Intervention Name(s)
Cefepime
Other Intervention Name(s)
Maxipime
Intervention Description
Antibiotic prophylaxis
Intervention Type
Drug
Intervention Name(s)
Cefuroxime plus Metronidazole
Other Intervention Name(s)
Zinnat plus Flagyl
Intervention Description
Antibiotic prophylaxis
Primary Outcome Measure Information:
Title
Incidence of surgical site wound infection
Description
Examining the wound after one week of the surgery to detect any infection
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: intrapartum caesarean section Exclusion Criteria: evidence of infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdalmageed Abdalmageed
Phone
+201007972027
Email
drosamast@yahoo.com.au
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Abdalmageed
Phone
01007972027
Email
drosamast1981@gmail.com
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdalmageed
Phone
1007972027
Email
drosamast@yahoo.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs