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

Sponsor

West Virginia University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01880112

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

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 Names: 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 Names: Ancef

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 Names:

Ancef

Active Comparator: 2 gram dose

Pre-operative prophylactic dose of 2 grams of cefazolin

Drug: Cefazolin

Other Names:

Ancef

Outcome Measures

Primary Outcome Measures

Cefazolin drug level. [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

BMI greater than 30.
Not undergoing Cesarean delivery.
Age less than 18 years.
Pre-existing infection.
Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
Cesarean delivery being performed under emergent circumstances