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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01904500
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : August 18, 2014
Information provided by (Responsible Party):
Omar M Young, MD, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Pregnancy Drug: Pre-operative cefazolin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Peri-operative Cefazolin Prophylaxis at Time of Cesarean Delivery in the Obese Gravida
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Cefazolin 2 grams Drug: Pre-operative cefazolin
Active Comparator: Cefazolin 3 grams Drug: Pre-operative cefazolin

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Adipose tissue concentrations of cefazolin [ Time Frame: Adipose tissue samples will be assessed at time of skin incision, hysterotomy closure and then fascial closure. ]
  2. Cmax [ Time Frame: Within the first 8 hours after skin incision ]
  3. Drug Clearance (Cl) [ Time Frame: Within the first 8 hours after skin incision ]
  4. Volume of distribution (Vd) [ Time Frame: Within the first 8 hours after skin incision ]
  5. Absolute drug concentrations in plasma and tissue [ Time Frame: Within the first 8 hours after skin incision ]
  6. Tissue to Plasma (T/P) Drug Concentration Ratios [ Time Frame: Within the first 8 hours after skin incision ]
  7. 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 ]
  8. Cord blood concentration [ Time Frame: At time of delivery ]
  9. Urine drug concentration [ Time Frame: 8 hours ]
    Samples to be obtained up to 8 hours post cesarean delivery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01904500

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


Responsible Party: Omar M Young, MD, Clinical Fellow, Division of Maternal-Fetal Medicine, University of Pittsburgh Identifier: NCT01904500     History of Changes
Other Study ID Numbers: PRO13040497
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014

Keywords provided by Omar M Young, MD, University of Pittsburgh:
Cesarean delivery

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents