to Investigate the Maternal Serum IL-17 Levels in Pregnant Women With Intrahepatic Cholestasis of Pregnancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- il-17 levels
研究概览
简要总结
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of pregnancy.
详细描述
Intrahepatic cholestasis of pregnancy (ICP) is the most prevalent pregnancy-specific liver disease. It occurs mainly in the second or third trimester of pregnancy. It typically resolves after delivery spontaneously but it is associated with an increased risk of adverse fetal outcomes.
The cause of ICP is heterogeneous, pathophysiology is poorly understood and therapies have been empiric. Genetic predispositions, environmental influences, dietary factors and hormonal influences have been studied and cited in the literature.
Comparing with placebo, ursodeoxycholic acid (UDCA) has been shown improvement in treatment of pruritus in previous studies. S-adenosylmethionine, guar gum, activated charcoal, dexamethasone, cholestyramine, etc. are not effective in the treatment of symptoms.
CD4+ T cells are an essential regulators of immune responses and inflammatory diseases. They are also called chief of orchestra cells of immune system. The balance between T helper-(Th)1, Th-2 and Th-17 cells and their cytokinergic interaction are crucial for the response of the organism. Th17 and its specific cytokine IL-17 are responsible for pathogenesis of autoimmune diseases as autoimmune uveitis, experimental autoimmune encephalomyelitis in animal models and potentially also in human autoimmune diseases such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, psoriasis, primary biliary cirrhosis. Recently, IL-17 targeted therapies (secukinumab, ixekizumab and brodalumab) are being studied in Phase III clinical trials to evaluate their overall efficacy and safety for certain autoimmune diseases.
Th-17 levels have been investigated in normal and abnormal pregnancies and results were incompatible with each other. Some researchers have said that the level of IL-17 increased during pregnancy but the others not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of ICP
排除标准
- •multiple pregnancies known chronic illness
结局指标
主要结局
il-17 levels
时间窗: 12 months
次要结局
未报告次要终点
研究者
Ayse Kirbas
ayse kirbas
Zekai Tahir Burak Women's Health Research and Education Hospital
