Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

June 12, 2013 updated by: Michael Stitely

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2 gram dose of cefazolin
2 gram dose of pre-operative cefazolin
Drug: cefazolin
2 gram dose for pre-operative prophylaxis
Other Names:
  • Ancef
Drug: cefazolin
4 gram dose for pre-operative prophylaxis
Other Names:
  • Ancef
Experimental: 4 gram Dose
4 gram dose of pre-operative prophylaxis
Drug: cefazolin
2 gram dose for pre-operative prophylaxis
Other Names:
  • Ancef
Drug: cefazolin
4 gram dose for pre-operative prophylaxis
Other Names:
  • Ancef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cefazolin Levels
Time Frame: 2 hours
Cefazolin levels
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Stitely

Investigators

  • Principal Investigator: William H Holls, MD, West Virginia University
  • Study Chair: Michael L Stitely, MD, West Virginia University

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

November 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22512

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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