Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida

August 15, 2014 updated by: Omar M Young, MD, University of Pittsburgh
Obesity has become an increasingly prevalent public health problem in the United States, reaching epidemic proportions. According to 2009 CDC epidemiologic data on obesity in the United States, 35.7% of the United States population is considered overweight or obese. Currently, on the review of the literature, over 20% of pregnancies in this country are complicated by maternal obesity. Obesity has been well demonstrated to be correlated with numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational diabetes, and increased rates of operative delivery. Moreover, obesity, irrespective of pregnancy, has been demonstrated to be an independent risk factor for the development of postoperative surgical site infections. Development of such infections can have both consequential long-term medical sequelae for patients and economic impacts on the health care system at large. Cefazolin, a first generation hydrophilic cephalosporin whose clearance is exclusively mediated via the kidneys unchanged, is used as pre-operative antibiotic prophylaxis for cesarean deliveries. The current accepted standard of care is to administer 2 grams of cefazolin within 60 minutes of skin incision. Studies of drug concentrations of cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric patients have shown that therapeutic concentrations may not be achieved in both tissue and plasma. Limited data exist in pregnancy. Therefore, it is the goal of this study to investigate whether obese patients presenting for cesarean delivery require an increased dosing amount of pre-operative antibiotic prophylaxis. This study will randomized women with a pre-pregnancy body mass index of 30 kg/m2 or more who are presenting for their scheduled cesarean delivery to receive either 2 grams or 3 grams of cefazolin for pre-operative antibiotic prophylaxis. By drawing blood at specific time points in the peri-operative period and extracting adipose tissue samples during cesarean delivery, this study will investigate the pharmacokinetics of cefazolin in both the plasma and tissues of the obese gravida.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 1

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Women's Hospital/University of Pittsburgh Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Body mass index (BMI) greater than 30kg/m2
  • Those women having scheduled primary or repeat cesarean delivery

Exclusion Criteria:

  • Type 1 and Type 2 Insulin Dependent Diabetes Mellitus
  • Autoimmune disease, including systemic lupus erythematosus
  • History of chronic renal disease
  • Those using chronic corticosteroids
  • Those with a history of a previous wound breakdown
  • Those who have an allergy to cephalosporins whose reaction includes anaphylaxis, urticaria or other systemic consequences
  • Those who are unable to receive their antibiotics in a timely fashion

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Cefazolin 2 grams
Drug: Pre-operative cefazolin
ACTIVE_COMPARATOR: Cefazolin 3 grams
Drug: Pre-operative cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma area under the curve (AUC) of cefazolin
Time Frame: Within the first 8 hours after skin incision
The primary aim of this study will be to evaluate the plasma area under the curve (AUC) of cefazolin in both the 2 grams and 3 grams groups. Blood samples will be obtained prior to administration of cefazolin and then 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 4 hours, 6 hours and 8 hours from administration of cefazolin
Within the first 8 hours after skin incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipose tissue concentrations of cefazolin
Time Frame: Adipose tissue samples will be assessed at time of skin incision, hysterotomy closure and then fascial closure.
Adipose tissue samples will be assessed at time of skin incision, hysterotomy closure and then fascial closure.
Cmax
Time Frame: Within the first 8 hours after skin incision
Within the first 8 hours after skin incision
Drug Clearance (Cl)
Time Frame: Within the first 8 hours after skin incision
Within the first 8 hours after skin incision
Volume of distribution (Vd)
Time Frame: Within the first 8 hours after skin incision
Within the first 8 hours after skin incision
Absolute drug concentrations in plasma and tissue
Time Frame: Within the first 8 hours after skin incision
Within the first 8 hours after skin incision
Tissue to Plasma (T/P) Drug Concentration Ratios
Time Frame: Within the first 8 hours after skin incision
Within the first 8 hours after skin incision
Surgical site infection fo any type
Time Frame: Participants will be followed for the duration of their hospital stay and will be called at 6 weeks from surgery
Participants will be followed for the duration of their hospital stay and will be called at 6 weeks from surgery
Cord blood concentration
Time Frame: At time of delivery
At time of delivery
Urine drug concentration
Time Frame: 8 hours
Samples to be obtained up to 8 hours post cesarean delivery
8 hours

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Omar Young, MD, Clinical Fellow, Division of Maternal-Fetal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (ESTIMATE)

July 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13040497

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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