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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01880112
• Other study ID #: H-23256
• Status: Withdrawn
• Phase: Phase 4
• First received: June 29, 2011
• Last updated: June 17, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Cesarean Delivery
• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	West Virginia University Hospital	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cefazolin drug level.	Measurement of the serum and tissue level of cefazolin.	Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.	No