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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-45
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 2 trial groups