Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor.
Materials and Methods
研究概览
地位
条件
详细说明
The purpose of the study is to compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor.
Materials and Methods This prospective observational case-control study will include 50 women admitted to the fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia. Preeclampsia is diagnosed as a new onset of hypertension over 140/90, at least two measurements at least four hours apart, and proteinuria (≥+1 in dipstick or >300 mg/24 hr) after 20 weeks of gestation in a previously normotensive woman.
A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period. Demographic, clinical, laboratory and sonographic data for the women participating will be collected from their chart. All patients diagnosed with preeclampsia will undergo the following workup: sign and symptoms evaluation, blood pressure follow up, 24-hour protein excretion in grams per day, complete blood count, hepatic function test: AST, ALT and coagulation study, HBA1C, coagulation function test and fibrotest. The Fibroscan test will be performed by a trained hepatologist, who was blind to the women diagnosis. The fibroscan test will be done during the admission after the diagnosis of preeclampsia, after delivery and 6 weeks post-partum.
Commonly used cutoffs are >7 kPa for significant fibrosis. Statistical analysis will be performed with SPSS using Mann Whitney test. Continuous variables will be analyzed using the student's T test and categorical variables were analyzed using 2. Statistical significance was set at a P value of < 0.05. The local institutional review board approved this study.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Nahariya、以色列
- 招聘中
- Galil Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Fetal-maternal Unit at 24 - 41 weeks gestation and diagnosed with mild/severe preeclampsia
Exclusion Criteria:
- Age less then 18
- Fetal-maternal less then 24 weeks
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Control group
A control group will consist 100 normotensive women with normal pregnancy outcomes who were admitted to our fetal-maternal unit during the same period
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Preeclampsia group
All patients diagnosed with preeclampsia will undergo the fibroscan test.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Comparing the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. Fibrotic tissue differs from healthy tissue in the way it responds to excitation
大体时间:2 years
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Transient elastography is performed using transducer-induced vibrations at low frequency (50 Hz) and amplitudes.
The transmitted shear waves propagate through the liver parenchyma.
Pulse-echo ultrasound acquisition is used to follow the propagation of the shear wave and to measure its average speed.
Results are expressed in kPa and can range from 2.5 to 75 kPa.
Commonly used cutoffs in clinical settings are >7 kPa for significant fibrosis and >11 to 14 kPa for cirrhosis and CAP>270 db/m2 for significant steatosis.
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2 years
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合作者和调查者
调查人员
- 首席研究员:Maya Wolf, MD、Western Galilee Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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