- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009772
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
July 3, 2019 updated by: Osama Saber Thabet Abdalmageed, Assiut University
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abdalmageed Abdalmageed
- Phone Number: +201007972027
- Email: drosamast@yahoo.com.au
Study Contact Backup
- Name: Osama Abdalmageed
- Phone Number: 01007972027
- Email: drosamast1981@gmail.com
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Assiut University
-
Contact:
- Abdalmageed
- Phone Number: 1007972027
- Email: drosamast@yahoo.com.au
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- intrapartum caesarean section
Exclusion Criteria:
- evidence of infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: "Cefepime" , "Maxipime®" 1 gm
Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision
|
Antibiotic prophylaxis
Other Names:
|
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
|
Antibiotic prophylaxis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of surgical site wound infection
Time Frame: one week
|
Examining the wound after one week of the surgery to detect any infection
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
February 1, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Antibiotic CS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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