NCT01755026

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Michael Stitely · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) 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 large women is 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 large women undergoing c-sections.

Conditions

• Cesarean Delivery
• Wound Infection
• Obesity

Interventions

Type	Name	Description
DRUG	cefazolin	2 gram dose for pre-operative prophylaxis
DRUG	cefazolin	4 gram dose for pre-operative prophylaxis

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2012-11-01
• First posted: 2012-12-21
• Last updated: 2013-08-21
• Results posted: 2013-08-21

Locations

1 site across 1 country: United States