Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Stitely, West Virginia University
ClinicalTrials.gov Identifier:
NCT01755026
First received: June 29, 2011
Last updated: June 12, 2013
Last verified: June 2013
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 West Virginia University:

Primary Outcome Measures:
  • Cefazolin Levels [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01755026     History of Changes
Other Study ID Numbers: H-22512
Study First Received: June 29, 2011
Results First Received: June 12, 2013
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infection
Obesity
Wound Infection
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Wounds and Injuries
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014