Bile Acids Metabolism and Genetic Mutation Profile in the ICP in the Indian Population

Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol/L (and elevated serum transaminases), with increased risks of perinatal complications, including spontaneous preterm labor, fetal distress, infant respiratory distress syndrome, meconium-stained liquor (MSL), and sudden intrauterine death (IUD). The Incidence of ICP varies from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).

Inclusion Criteria -Age > 21 years with consistent pruritusCharacterized 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 performedVoluntary informed consent to participate until their delivery and also willing to be followed until their deliveryAgrees to provide information on perinatal and maternal outcomes at or after deliveryExclusion 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 pruritusMetabolic diseases (including alcohol abuse)Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)Autoimmune liver diseaseObstructive biliary diseasesCholestatic drug-induced liver injuryClinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseasesTwins and triplet pregnancy