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

Phase 4

Withdrawn

• Conditions: Infection; Cesarean Delivery; Antibiotic Prophylaxis
• Interventions: Drug: Cefazolin

• Registration Number: NCT01880112
• Lead Sponsor: West Virginia University

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 available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-29
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-17
• Last Update Submitted: 2013-06-17
• Study First Posted: 2013-06-18
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 gram dose	Cefazolin	Pre-operative prophylactic dose of 4 grams of cefazolin
2 gram dose	Cefazolin	Pre-operative prophylactic dose of 2 grams of cefazolin

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States