跳至主要内容
临床试验/NCT01880112
NCT01880112撤回4 期

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

West Virginia University1 个研究点 分布在 1 个国家开始时间: 2011年6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
撤回
试验地点
1
主要终点
Cefazolin drug level.

研究概览

简要总结

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less 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 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 normal weight 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 30 or less, as calculated from the height and weight at the first prenatal visit
  • Undergoing cesarean delivery

排除标准

  • BMI greater 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

4 gram dose

Experimental

Pre-operative prophylactic dose of 4 grams of cefazolin

干预措施: Cefazolin (Drug)

2 gram dose

Active Comparator

Pre-operative prophylactic dose of 2 grams of cefazolin

干预措施: Cefazolin (Drug)

结局指标

主要结局

Cefazolin drug level.

时间窗: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.

Measurement of the serum and tissue level of cefazolin.

次要结局

未报告次要终点

研究者

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

Michael Stitely

Adjunct Associate Professor

West Virginia University

研究点 (1)

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