drugset / Trial / NCT01880112

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

NCT01880112

Phase 4 Withdrawn West Virginia University
RandomizedParallel-groupSingle-blindBasic science

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.

Timeline

Start
2011-06
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefazolin Small molecule 2 g
Subject Cefazolin Small molecule 4 g

Indications