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Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.

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ClinicalTrials.gov Identifier: NCT01880112
Recruitment Status : Withdrawn (There is no longer need for this study.)
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Stitely, West Virginia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infection Cesarean Delivery Antibiotic Prophylaxis Drug: Cefazolin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Experimental: 4 gram dose
Pre-operative prophylactic dose of 4 grams of cefazolin
 Drug: Cefazolin
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.
Other Name: Ancef
Active Comparator: 2 gram dose
Pre-operative prophylactic dose of 2 grams of cefazolin
 Drug: Cefazolin
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.
Other Name: Ancef


Outcome Measures
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Primary Outcome Measures :
  1. Cefazolin drug level. [ Time Frame: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes. ]
    Measurement of the serum and tissue level of cefazolin.


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

Inclusion Criteria:

  1. Age 18 years or above
  2. Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
  3. Undergoing cesarean delivery

Exclusion Criteria:

  1. BMI greater than 30.
  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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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): NCT01880112


Locations
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United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: William H Holls, MD West Virginia University
Study Chair: Michael L Stitely, MD West Virginia University
More Information
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Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01880112     History of Changes
Other Study ID Numbers: H-23256
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Michael Stitely, West Virginia University:
Infection
Cesarean delivery
Antibiotic prophylaxis
Cefazolin dosing
Additional relevant MeSH terms:
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Infection
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents