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

July 10, 2013
August 15, 2014
August 2013
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01904500 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida
Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Pregnancy
Drug: Pre-operative cefazolin
  • Cefazolin 2 grams
    Intervention: Drug: Pre-operative cefazolin
  • Active Comparator: Cefazolin 3 grams
    Intervention: Drug: Pre-operative cefazolin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01904500
PRO13040497
Not Provided
Omar M Young, MD, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Omar Young, MD Clinical Fellow, Division of Maternal-Fetal Medicine
University of Pittsburgh
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP