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临床试验/NCT04004897
NCT04004897已完成不适用

Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年7月5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
ICP

研究概览

简要总结

Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study targets to evaluate the ICP in patients with or without preeclampsia.

详细描述

MRI studies have shown that brain edema due to an elevation in ICP develops in up to 70% of women with preeclampsia. Optic nerve sheath diameter is used to estimate the ICP and has been shown to correlate well with invasive ICP measurement. The present study aims to compare ICP using optic nerve sheath diameter in women with or without preeclampsia.

研究设计

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

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Must be diagnosed as preeclampsia
  • Age must be > 18 years

排除标准

  • History of previous intracranial pathology or surgery

结局指标

主要结局

ICP

时间窗: At 6th hour of admission

The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia

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

Huseyin Kiyak

Principal Investigator, M.D.

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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