Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Delivery Body Weight Infections Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or above
Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
Undergoing cesarean delivery

Exclusion criteria

BMI less than 35.
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.

Treatment and study plan

Cefazolin

Drug

2 gram dose for pre-operative prophylaxis

Other names: Ancef

Primary outcomes

Cefazolin Levels

Time frame: 2 hours

Cefazolin levels

Sponsors and collaborators

Lead sponsor

Michael Stitely

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Dec 21, 2012
Registry last updated: Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed