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临床试验/NCT01904500
NCT01904500已完成1 期

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

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
26
试验地点
1
主要终点
Plasma area under the curve (AUC) of cefazolin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Cefazolin 2 grams

Other

干预措施: Pre-operative cefazolin (Drug)

Cefazolin 3 grams

Active Comparator

干预措施: Pre-operative cefazolin (Drug)

结局指标

主要结局

Plasma area under the curve (AUC) of cefazolin

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar M Young, MD

Clinical Fellow, Division of Maternal-Fetal Medicine

University of Pittsburgh

研究点 (1)

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