Back to resultsSerum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
Primary Purpose
Infection, Cesarean Delivery, Antibiotic Prophylaxis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cefazolin
Sponsored by
About this trial
This is an interventional basic science trial for Infection focused on measuring Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or above
- Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
- Undergoing cesarean delivery
Exclusion Criteria:
- BMI greater than 30.
- Not undergoing Cesarean delivery.
- Age less than 18 years.
- Pre-existing infection.
- Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
- Cesarean delivery being performed under emergent circumstances
Sites / Locations
- West Virginia University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4 gram dose
2 gram dose
Arm Description
Pre-operative prophylactic dose of 4 grams of cefazolin
Pre-operative prophylactic dose of 2 grams of cefazolin
Outcomes
Primary Outcome Measures
Cefazolin drug level.
Measurement of the serum and tissue level of cefazolin.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01880112
Brief Title
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
Official Title
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
There is no longer need for this study.
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. It is unknown what the best dose for the usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level. These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in normal weight women undergoing c-sections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Cesarean Delivery, Antibiotic Prophylaxis
Keywords
Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 gram dose
Arm Type
Experimental
Arm Description
Pre-operative prophylactic dose of 4 grams of cefazolin
Arm Title
2 gram dose
Arm Type
Active Comparator
Arm Description
Pre-operative prophylactic dose of 2 grams of cefazolin
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Other Intervention Name(s)
Ancef
Intervention Description
Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed.
Primary Outcome Measure Information:
Title
Cefazolin drug level.
Description
Measurement of the serum and tissue level of cefazolin.
Time Frame
Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or above
Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
Undergoing cesarean delivery
Exclusion Criteria:
BMI greater than 30.
Not undergoing Cesarean delivery.
Age less than 18 years.
Pre-existing infection.
Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
Cesarean delivery being performed under emergent circumstances
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H Holls, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael L Stitely, MD
Organizational Affiliation
West Virginia University
Official's Role
Study Chair
Facility Information:
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
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