Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
1 other identifier
interventional
500
1 country
1
Brief Summary
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJuly 5, 2019
July 1, 2019
7 months
July 1, 2019
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of surgical site wound infection
Examining the wound after one week of the surgery to detect any infection
one week
Study Arms (2)
"Cefepime" , "Maxipime®" 1 gm
ACTIVE COMPARATORPatient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision
"Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500
ACTIVE COMPARATORPatient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section
Interventions
Antibiotic prophylaxis
Eligibility Criteria
You may qualify if:
- intrapartum caesarean section
You may not qualify if:
- evidence of infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assiut Universitylead
- Yasser Esmat Mohammedcollaborator
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant of Obstetrics and gynecology
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
July 1, 2019
Primary Completion
February 1, 2020
Study Completion
March 1, 2020
Last Updated
July 5, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share