Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- genetic polymorphisms in pregnant women with ICP and in their first degree relatives
研究概览
简要总结
To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.
详细描述
Introduction
ICP is commolnly manifested in the 2nd and especially in the 3rd trimester of pregnancy. Pathogenesis of ICP is multifactorial implicating genetic, environmental and hormonologic factors. Prevalence of ICP varies. In certain populations in latin America occurrence of ICP is up to 15% of pregnancies. In Caucasian populations incidence of ICP is approximately 1% of pregnancies. Data for the Greek population are scarce. Genes ABCB4 and ABCB11 that are encoding transport proteins in the hepatocyte are implicated in the pathogenesis of ICP.
Aim of the Study: To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives Patients and Methods: To recruit 100 women with ICP. Analyze the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in women with ICP. As control group will be used pregnant women without ICP or known hepatic disease. In these women the same analysis for SNP's as in women with ICP will be performed. Exclusion criteria: women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis) and women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome) Inclusion criteria: pregnant women with ICP. Detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. Follow up of laboratory values before and after the begging of treatment with UDCA.
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 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with ICP
排除标准
- •women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis)
- •women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome)
研究组 & 干预措施
ICP
To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives
干预措施: ursofalk (Drug)
结局指标
主要结局
genetic polymorphisms in pregnant women with ICP and in their first degree relatives
时间窗: 01/01/2018-31/01/2021
次要结局
未报告次要终点
研究者
SPYRIDON MICHOPOULOS
Head Of The Gastroenterology Departement
Alexandra Hospital, Athens, Greece
