Investigating bile acids and genetic mutations in pregnancy-related liver disorder in Indian women

Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in the Indian Population- A Prospective Study

This study is testing the connection between bile acids and genetic changes in Indian women with a pregnancy-related liver condition called Intrahepatic Cholestasis of Pregnancy to see how it affects them and their babies.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 21 Years to 45 Years
• Sex: Female
• Sponsor: PGIMER (unknown)
• Locations: 1 site (Chandigarh)
• Trial ID: NCT05691036 on ClinicalTrials.gov

What this trial studies

This observational study focuses on Intrahepatic Cholestasis of Pregnancy (ICP), a condition characterized by severe itching and elevated bile acids during pregnancy. It aims to analyze the metabolic profile of bile acids and the genetic mutation profile in affected women from the Indian population. The study will include women over 21 years old who experience consistent pruritus and elevated liver enzymes or bile acids. Participants will be monitored until delivery to assess maternal and perinatal outcomes.

Who should consider this trial

Good fit: Ideal candidates are pregnant women over 21 years old with consistent itching and elevated liver enzymes or bile acids.

Not a fit: Patients with viral liver diseases or primary dermatologic conditions causing pruritus will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of ICP, potentially improving outcomes for mothers and their babies.

How similar studies have performed: While there have been studies on ICP, this specific focus on bile acids and genetic mutations in the Indian population is relatively novel.

Eligibility criteria

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

Where this trial is running

Chandigarh

• Dr. Madhumita Premkumar — Chandigarh, India (RECRUITING)

Study contacts

• Principal investigator: Madhumita Premkumar — PGIMER, Chandigarh
• Study coordinator: Dr Madhumita Premkumar, DM

Conditions: Intrahepatic Cholestasis of Pregnancy, Genetic Mutation, Health Related Quality of Life, Intrahepatic cholestasis of pregnancy, Genetic Mutations in pregnancy associated cholestasis, Pruritus