BIOCHEMICAL MILIEU IN INTRAHEPATIC CHOLESTASIS OF PREGNANCY AND ITS IMPROVEMENT WITH URSODEOXYCHOLIC ACID
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To establish the effect of ursodeoxycholic acid in the liver biochemical markers [Serum bile acid, Serum bilirubin, serum liver transaminases (ALT, AST), alkaline phosphatase] in Patients of IHCP.
研究概览
简要总结
Intrahepatic cholestasis of pregnancy (IHCP) or obstetric cholestasis is the pregnancy related liver disorder more commonly occurring in late second and third trimester of pregnancy. Ursodeoxycholic acid (UDCA) is a secondary bile acid synthesized in humans by intestinal bacteria. It is the most effective medical treatment. This study is being done to see the response after therapy in the form of symptomatic and biochemical relief at 7th and 14th days of treatment with ursodeoxycholic acid and thereafter fortnightly and they followed till delivery to assess the feto-maternal outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women in late 2nd (26-28 weeks) and 3rd trimester with Intrahepatic cholestasis of pregnancy.
排除标准
- •1.Preeclampsia, eclampsia 2.Acute fatty liver of pregnancy 3.Viral hepatitis (HAV, HBV, HCV, HEV).
- •4.Liver cirrhosis, tumors 5.Autoimmune liver disease.
- •6.Obstructive biliary disease.
- •• Known kidney diseases.
- •• Dermatoses of pregnancy- Gestational pemphigoid, pruritic and urticarial papules and plaques (PUPPP), atopic eruption of pregnancy i.e., eczema and prurigo.
- •• Impetigo herpetiformis- triggered by pregnancy.
结局指标
主要结局
To establish the effect of ursodeoxycholic acid in the liver biochemical markers [Serum bile acid, Serum bilirubin, serum liver transaminases (ALT, AST), alkaline phosphatase] in Patients of IHCP.
时间窗: 1 week and 2weeks
次要结局
- To assess the perinatal outcome after ursodeoxycholic acid therapy in IHCP(1 week & 2 weeks)
研究者
RUCHI PATEL
MLN MEDICAL COLLEGE ALLAHABAD