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Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

Primary Purpose

Cesarean Delivery, Wound Infection, Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
cefazolin
cefazolin
Sponsored by
Michael Stitely
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cesarean Delivery focused on measuring Cesarean Delivery, Wound infection, Obesity, Prophylactic antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years or above
  2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
  3. Undergoing cesarean delivery

Exclusion Criteria:

  1. BMI less than 35.
  2. Not undergoing Cesarean delivery.
  3. Age less than 18 years.
  4. Pre-existing infection.
  5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
  6. Cesarean delivery being performed under emergent circumstances.

Sites / Locations

  • West Virginia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2 gram dose of cefazolin

4 gram Dose

Arm Description

2 gram dose of pre-operative cefazolin

4 gram dose of pre-operative prophylaxis

Outcomes

Primary Outcome Measures

Cefazolin Levels
Cefazolin levels

Secondary Outcome Measures

Full Information

First Posted
June 29, 2011
Last Updated
June 12, 2013
Sponsor
Michael Stitely
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1. Study Identification

Unique Protocol Identification Number
NCT01755026
Brief Title
Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery
Official Title
Serum and Tissue Cefazolin Concentrations in 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
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Stitely

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) 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 large women is 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 large women undergoing c-sections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Delivery, Wound Infection, Obesity
Keywords
Cesarean Delivery, Wound infection, Obesity, Prophylactic antibiotics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 gram dose of cefazolin
Arm Type
Active Comparator
Arm Description
2 gram dose of pre-operative cefazolin
Arm Title
4 gram Dose
Arm Type
Experimental
Arm Description
4 gram dose of pre-operative prophylaxis
Intervention Type
Drug
Intervention Name(s)
cefazolin
Other Intervention Name(s)
Ancef
Intervention Description
2 gram dose for pre-operative prophylaxis
Intervention Type
Drug
Intervention Name(s)
cefazolin
Other Intervention Name(s)
Ancef
Intervention Description
4 gram dose for pre-operative prophylaxis
Primary Outcome Measure Information:
Title
Cefazolin Levels
Description
Cefazolin levels
Time Frame
2 hours

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 35 or greater at the time of the first obstetric clinic visit Undergoing cesarean delivery Exclusion Criteria: BMI less than 35. 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

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Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

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