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临床试验/NCT02391467
NCT02391467暂停不适用

Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study

Hopital Lariboisière1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
25
试验地点
1
主要终点
Difference between the fibrosis score during and after pregnancy

研究概览

简要总结

Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

详细描述

One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Pregnant women
  • Followed in Obstetrics Dpt
  • HBV or HCV chronic hepatitis
  • After information and written consent

排除标准

  • 未提供

结局指标

主要结局

Difference between the fibrosis score during and after pregnancy

时间窗: 3 to 6 months after delivery

次要结局

未报告次要终点

研究者

发起方
Hopital Lariboisière
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephane Mouly, MD PhD

Professor Paris VII University, Paris, France

Hopital Lariboisière

研究点 (1)

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