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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection, Cesarean Delivery, Antibiotic Prophylaxis

Intervention / Treatment
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* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 gram dose<br>Pre-operative prophylactic dose of 4 grams of cefazolin | Drug: Cefazolin<br>* 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.<br>* Other names: Ancef;|
| Active Comparator: 2 gram dose<br>Pre-operative prophylactic dose of 2 grams of cefazolin | Drug: Cefazolin<br>* 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.<br>* Other names: Ancef;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, Cesarean delivery, Antibiotic prophylaxis, Cefazolin dosing