Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population

NCT05691036 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Observational

Started

2022-12-08

Last updated

2026-05-18

Condition(s) studied

Intrahepatic Cholestasis of PregnancyGenetic MutationHealth Related Quality of Life

Study summary

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%).

Eligibility

Sex

FEMALE

Min age

21 Years

Max age

45 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP. — At Enrolment
Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)
Change in the profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP. — At Delivery
Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)

Trial sites (1)

Facility	City	Region	Status
Dr. Madhumita Premkumar	Chandigarh	Chandigarh	Recruiting