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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Recruitment Status : Withdrawn (There is no longer need for this study.)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

Tracking Information
First Submitted Date  ICMJE June 29, 2011
First Posted Date  ICMJE June 18, 2013
Last Update Posted Date June 18, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
Official Title  ICMJE Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Infection
  • Cesarean Delivery
  • Antibiotic Prophylaxis
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: 4 gram dose
    Pre-operative prophylactic dose of 4 grams of cefazolin
    Intervention: Drug: Cefazolin
  • Active Comparator: 2 gram dose
    Pre-operative prophylactic dose of 2 grams of cefazolin
    Intervention: Drug: Cefazolin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880112
Other Study ID Numbers  ICMJE H-23256
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Stitely, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William H Holls, MD West Virginia University
Study Chair: Michael L Stitely, MD West Virginia University
PRS Account West Virginia University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP