CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
cefazolin +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01755026
NCT01755026Phase 4Completed

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

Michael Stitely·interventional·Posted Dec 21, 2012·Updated Aug 21, 2013

In Brief

A Phase 4 clinical trial evaluating cefazolin for Cesarean Delivery and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2012
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2011
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.5 years ago

Interventions

cefazolindrug

2 gram dose for pre-operative prophylaxis

cefazolindrug

4 gram dose for pre-operative prophylaxis