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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dr. Madhumita Premkumar
  Chandigarh, Chandigarh, India Recruiting

Study contacts

• Principal investigator: Madhumita Premkumar — PGIMER, Chandigarh
• Study coordinator: Dr Madhumita Premkumar, DM
• Email: drmadhumitap@gmail.com
• Phone: 7087003409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.