Increased Cefazolin During Cesarean Delivery in Obese Population

January 12, 2021 updated by: MemorialCare Health System

Increased Cefazolin (Ancef) Dosing for Prophylaxis During Cesarean Delivery in the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design:

This is a follow-up to the original pilot study (HS# 2009-7015 at UCI/587-08 at LBMMC). This study is also designed to be a prospective, non-randomized, non-blinded trial of the effects of obesity on adequacy of antimicrobial (cefazolin) concentrations with increased doses (from 2 grams to 3 grams) of preoperative prophylactic antibiotics within adipose tissues at the time of cesarean delivery.

Inclusion Criteria:

• Patients at term (>37 weeks) undergoing a cesarean delivery at LBMMC and UCI.

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

Study Procedure:

All patients requiring cesarean delivery under non-emergent circumstances, as determined by their physician, will be approached for participation in study by co-investigators. They will be approached on Labor and Delivery during their intake evaluation on the day of their scheduled procedure. Based on published literature and preliminary power analysis we expect that each of the 2 study groups will need 1414 subjects to demonstrate statistically significant difference in antibiotic concentrations within adipose tissue. The two groups will consist of:

  1. OBESE GROUP (BMI 30-40)

  2. MORBIDLY OBESE GROUP (BMI >40)

    1. All subjects will receive cefazolin at least 30, but no more than 60 minutes prior to skin incision.

    2. At the time of cesarean delivery, the following tissue samples will be collected:

      • adipose tissue immediately following skin incision (prior to incision of the fascia) and
      • adipose tissue prior to skin closure
      • serum sample after skin incision but prior to completion of the operative procedure

Approximately 2 grams of tissue sampled from each site and 5 cc of blood will be required for analysis.

All samples will be collected by Dr. Swank, Dr. Wing or a physician who had previously been proctored in the proper tissue collecting techniques by either of the above mentioned investigators. Upon collection, tissue specimens will be blotted to remove residual blood and debris, weighed, and placed in a freezer (-80'C) until analysis. Serum samples will be drawn into red top tubes and immediately placed on wet ice. Immediately following completion of the surgery, they will then be centrifuged for 10 minutes at 3G (3200 rpm) and placed in a locked -80'C freezer until analysis.

Tissue and serum samples will then be sent to David P. Nicolau, PhD, FCCP, FIDSA, at the Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, Connecticut. Samples will be batched and sent all together at the completion of study enrollment. Dr. Swank and the study nurse will be responsible for securely packing samples on dry ice and overnight shipping them to Dr. Nicolau. Once with Dr. Nicolau, the tissue samples will be homogenized and analyzed to determine zones of inhibition. The Cefazolin concentrations will be determined in the serum samples using a previously validated high-performance liquid chromatography method. 16 Tissues and serum will be sent without direct identifiers. Dr. Nicolau will not have access to the identity of the research subjects providing the samples.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center
      • Orange, California, United States, 92868
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ancef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery
Time Frame: Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.

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
Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare Health System

Collaborators

University of California, Irvine

Investigators

  • Principal Investigator: Deborah A Wing, MD, University of California, Irvine
  • Principal Investigator: Jennifer McNulty, MD, MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center
  • Principal Investigator: Morgan Swank, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 186-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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