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临床试验/NCT01755026
NCT01755026已完成4 期

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.

Michael Stitely1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Cefazolin Levels

研究概览

简要总结

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

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

  • Age 18 years or above
  • Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
  • Undergoing cesarean delivery

排除标准

  • BMI less than
  • Not undergoing Cesarean delivery.
  • Age less than 18 years.
  • Pre-existing infection.
  • Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
  • Cesarean delivery being performed under emergent circumstances.

研究组 & 干预措施

2 gram dose of cefazolin

Active Comparator

2 gram dose of pre-operative cefazolin

干预措施: cefazolin (Drug)

4 gram Dose

Experimental

4 gram dose of pre-operative prophylaxis

干预措施: cefazolin (Drug)

结局指标

主要结局

Cefazolin Levels

时间窗: 2 hours

Cefazolin levels

次要结局

未报告次要终点

研究者

发起方
Michael Stitely
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Stitely

Adjunct Associate Professor

West Virginia University

研究点 (1)

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