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Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755026
First Posted: December 21, 2012
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
  Purpose
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.

Condition Intervention Phase
Cesarean Delivery Wound Infection Obesity Drug: cefazolin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.

Resource links provided by NLM:


Further study details as provided by Michael Stitely, West Virginia University:

Primary Outcome Measures:
  • Cefazolin Levels [ Time Frame: 2 hours ]
    Cefazolin levels


Enrollment: 23
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 gram dose of cefazolin
2 gram dose of pre-operative cefazolin
Drug: cefazolin
2 gram dose for pre-operative prophylaxis
Other Name: Ancef
Experimental: 4 gram Dose
4 gram dose of pre-operative prophylaxis
Drug: cefazolin
4 gram dose for pre-operative prophylaxis
Other Name: Ancef

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755026


Locations
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Michael Stitely
Investigators
Principal Investigator: William H Holls, MD West Virginia University
Study Chair: Michael L Stitely, MD West Virginia University
  More Information

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01755026     History of Changes
Other Study ID Numbers: H-22512
First Submitted: June 29, 2011
First Posted: December 21, 2012
Results First Submitted: June 12, 2013
Results First Posted: August 21, 2013
Last Update Posted: August 21, 2013
Last Verified: June 2013

Keywords provided by Michael Stitely, West Virginia University:
Cesarean Delivery
Wound infection
Obesity
Prophylactic antibiotics

Additional relevant MeSH terms:
Wound Infection
Infection
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents