Increased Cefazolin During Cesarean Delivery in Obese Population
The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophylactic dose, can then be compared to our pilot study assays in hopes of determining an optimal dosing for the obese and morbidly obese populations undergoing cesarean delivery.
A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the obese and extremely obese populations. The purpose of this research study is to evaluate whether in increased dose of antibiotics given before cesarean delivery (3 grams of cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an effect on the levels of antibiotics in the tissues (a group of similar cells).
This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index (BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC. Researchers hope to enroll a total of 35 women overall.
Infection; Cesarean Section
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Increased Cefazolin (Ancef) Dosing for Prophylaxis During Cesarean Delivery in the Obese Population|
- Achievement of minimal inhibitory concentrations within adipose and serum sampled at time of cesarean delivery [ Time Frame: Samples will be frozen and batched and run at completion of the study. Goal for sample collection to be complete over a 6-9 month time period with samples run as a batch within a month of sample collection completion. ] [ Designated as safety issue: No ]
To assess the effects of increased prophylactic doses of Cefazolin in the obese and morbidly obese populations undergoing cesarean delivery. Effects will be defined as the ability to reach the minimal inhibitory concentrations for gram-positive and gram-negative organisms in adipose tissue and serum at time of skin incision and skin closure as defined by the Clinical and Laboratory Standards Institute
|Study Start Date:||August 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
All subjects undergoing elective term cesarean delivery will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision.
Participants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line.
Other Name: Ancef
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02049944
|United States, California|
|MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center|
|Long Beach, California, United States, 90806|
|University of California, Irvine|
|Orange, California, United States, 92868|
|Principal Investigator:||Jennifer McNulty, MD||MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center|
|Principal Investigator:||Deborah A Wing, MD||University of California, Irvine|
|Principal Investigator:||Morgan Swank, MD||University of California, Irvine|