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临床试验/NCT03556267
NCT03556267已完成不适用

Role of Beta Trace Protein Assay During Spinal Anesthesia of Cesarean Section

Cairo University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
CSF sample: serum sample

研究概览

简要总结

Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

详细描述

Beta trace protein is specific for CSF only and it is a quantitative analytic test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-45 years old
  • free medical history.
  • free obstetric history.

排除标准

  • high risk pregnancy.

结局指标

主要结局

CSF sample: serum sample

时间窗: One year

After insertion of an intravenous line 4 ml serum will be collected, then 0.5 ml CSF sample will be collected after insertion of the dura by the selected spinal needle before injecting the anesthetic drugs used for spinal anesthesia. Beta trace protein assay will be measured through ELISA technique in both CSF and serum samples and the ratio will be calculated and measured. This ratio will be measured for the three arms aiming at the comparison between the three devices regarding the CSF : Serum ratio.

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

Reham Ali Abdelhaleem Abdelrahman

Principal Investigator

Cairo University

研究点 (2)

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