Back to resultsCefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Primary Purpose
Cesarean Section; Infection
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cefepime 1000 MG
Ampicillin-sulbactam
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section; Infection focused on measuring surgical site infection, Cefepime
Eligibility Criteria
Inclusion Criteria: Pregnant women within age group more than18 years. Pregnant women with elective cesarean delivery. Previous and primary cesarean delivery. Exclusion Criteria: Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia. Women who had a skin infection adjacent to the operative site.
Sites / Locations
- Beni-suef university Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cefepime Group
Ampicillin/Sulbactam
Arm Description
Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD
Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD
Outcomes
Primary Outcome Measures
surgical site infection
pain, redness, swelling, warm skin around the wound, yellow or green discharge
Secondary Outcome Measures
Full Information
NCT ID
NCT06048692
First Posted
September 16, 2023
Last Updated
September 16, 2023
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT06048692
Brief Title
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Official Title
The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.
Detailed Description
A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section; Infection
Keywords
surgical site infection, Cefepime
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cefepime Group
Arm Type
Experimental
Arm Description
Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD
Arm Title
Ampicillin/Sulbactam
Arm Type
Active Comparator
Arm Description
Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD
Intervention Type
Drug
Intervention Name(s)
Cefepime 1000 MG
Other Intervention Name(s)
maxipime
Intervention Description
Cefepime is a fourth-generation cephalosporin antibiotic
Intervention Type
Drug
Intervention Name(s)
Ampicillin-sulbactam
Other Intervention Name(s)
unictam
Intervention Description
Broad-Spectrum Antibiotic
Primary Outcome Measure Information:
Title
surgical site infection
Description
pain, redness, swelling, warm skin around the wound, yellow or green discharge
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women within age group more than18 years.
Pregnant women with elective cesarean delivery.
Previous and primary cesarean delivery.
Exclusion Criteria:
Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.
Women who had a skin infection adjacent to the operative site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beni-Suef University
Organizational Affiliation
Faculty of Medicine Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-suef university Hospital
City
Banī Suwayf
State/Province
Beni Suef
ZIP/Postal Code
62521
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
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