Increased Cefazolin During Cesarean Delivery in Obese Population

This study has been completed.
Sponsor:
Collaborator:
University of California, Irvine
Information provided by (Responsible Party):
MemorialCare Health System
ClinicalTrials.gov Identifier:
NCT02049944
First received: January 24, 2014
Last updated: January 7, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Obesity
Obesity, Morbid
Pregnancy
Infection; Cesarean Section
Drug: Cefazolin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by MemorialCare Health System:

Primary Outcome Measures:
  • 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 ]

    Primary Objective:

    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



Enrollment: 28
Study Start Date: August 2013
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cefazolin
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.
Drug: Cefazolin
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at Miller Children's Hospital and University of California, Irvine.

Exclusion Criteria:

  • pre-gestational diabetes
  • chronic hypertension
  • collagen vascular disease
  • renal impairment
  • multiple gestation
  • contraindications to Cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
  • any exposure to cephalosporins in one week prior to cesarean section
  • need for emergent cesarean delivery or diagnosis of chorioamnionitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049944

Locations
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
Sponsors and Collaborators
MemorialCare Health System
University of California, Irvine
Investigators
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
  More Information

No publications provided

Responsible Party: MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02049944     History of Changes
Other Study ID Numbers: 186-13
Study First Received: January 24, 2014
Last Updated: January 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare Health System:
Antibiotic Prophylaxis
Obesity
Obesity, Morbid
Pregnancy
Infection; Cesarean Section

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015