Yükleniyor... / Loading...
This observational study examines bile acid metabolism and the genetic mutation profile in patients with intrahepatic cholestasis of pregnancy in an Indian population. It enrolls pregnant people over 21 years of age who have itching along with elevated liver enzymes or bile acids. It is an observational study without an assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria - * Age \> 21 years with consistent pruritus * Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \> 40 U/L or AST \> 37 U/L) or raised total serum bile acids (≥ 10 µmol/L) * Able to understand and comply with the requirements of the study and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed * Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery * Agrees to provide information on perinatal and maternal outcomes at or after delivery Exclusion Criteria: * Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) related liver disease, Epstein Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV) infection) hepatitis C virus (HBV), hepatitis E virus (HEV) * Primary dermatologic diseases associated with pruritus * Metabolic diseases (including alcohol abuse) * Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC) * Autoimmune liver disease * Obstructive biliary diseases * Cholestatic drug-induced liver injury * Clinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseases * Twins and triplet pregnancy