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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omar M Young, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01904500
First received: July 10, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Pregnancy
Drug: Pre-operative cefazolin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Plasma area under the curve (AUC) of cefazolin [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Adipose tissue concentrations of cefazolin [ Time Frame: Adipose tissue samples will be assessed at time of skin incision, hysterotomy closure and then fascial closure. ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
  • Drug Clearance (Cl) [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
  • Volume of distribution (Vd) [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
  • Absolute drug concentrations in plasma and tissue [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
  • Tissue to Plasma (T/P) Drug Concentration Ratios [ Time Frame: Within the first 8 hours after skin incision ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cord blood concentration [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
  • Urine drug concentration [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Samples to be obtained up to 8 hours post cesarean delivery


Estimated Enrollment: 26
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cefazolin 2 grams Drug: Pre-operative cefazolin
Active Comparator: Cefazolin 3 grams Drug: Pre-operative cefazolin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01904500

Locations
United States, Pennsylvania
Magee-Women's Hospital/University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Omar Young, MD Clinical Fellow, Division of Maternal-Fetal Medicine
  More Information

Publications:

Responsible Party: Omar M Young, MD, Clinical Fellow, Division of Maternal-Fetal Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01904500     History of Changes
Other Study ID Numbers: PRO13040497
Study First Received: July 10, 2013
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board
United States: Magee-Women's Hospital/ University of Pittsburgh Medical Center

Keywords provided by University of Pittsburgh:
Cesarean delivery

Additional relevant MeSH terms:
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014