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临床试验/NCT01810354
NCT01810354已完成不适用

PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN: Does Increasing the Dose Increase the Tissue Concentration?

Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Adipose tissue concentration of cefazolin

研究概览

简要总结

Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin.

Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery.

Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis.

While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)]greater than or equal to 30 as determined at their first prenatal visit
  • Gestational age of 37 0/7 weeks and greater
  • Singleton Pregnancy
  • Non-emergent cesarean section

排除标准

  • Known cephalosporin allergy
  • Severe allergy to penicillin making cephalosporin use a contraindication
  • Exposure to antibiotics in the preceding 7 days
  • Need for emergent cesarean section
  • Multiple gestations
  • Suspected chorioamnionitis
  • Pre-gestational diabetes
  • Chronic hypertension with evidence of end organ damage

研究组 & 干预措施

Two grams cefazolin

Experimental

Two grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section.

干预措施: Cefazolin (Drug)

Three grams cefazolin

Active Comparator

Three grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section.

干预措施: Cefazolin (Drug)

结局指标

主要结局

Adipose tissue concentration of cefazolin

时间窗: At the start of the cesarean section and at the end of the cesarean section

Two separate two gram samples of adipose tissue will be removed from the subcutaneous tissue. The first sample will be removed after skin incision, yet prior to fascial incision. The second sample will be collected after fascial closure, yet prior to skin closure.

次要结局

  • Serum cefazolin concentrations(After antibiotic infusion, at the start of the cesarean section, and at the end of the cesarean section)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Maggio,

Maternal-Fetal Medicine Fellow

Women and Infants Hospital of Rhode Island

研究点 (1)

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