Actively Recruiting
Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in Indian Population - A Prospective Study
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-05-18
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder during pregnancy characterized by itching and elevated levels of bile acids and liver enzymes. It increases the risk of complications such as preterm labor, fetal distress, and sudden intrauterine death. The incidence of ICP varies by region and ethnicity, with notable rates in parts of India. This study aims to explore bile acid metabolism and genetic mutations related to ICP in the Indian population, assessing how these factors affect pregnancy outcomes and quality of life. The study compares pregnant women diagnosed with ICP to healthy pregnant women of similar gestational age. Women with ICP will be identified based on symptoms like persistent itching and elevated serum transaminases or bile acids. Researchers will analyze serum bile acid profiles and genetic mutations, while also monitoring clinical outcomes and quality of life. Data will be collected at enrollment and delivery, with follow-up until delivery to record maternal and perinatal outcomes. Participants will undergo assessments including blood tests for bile acids and liver function, pruritus measurement using a visual analog scale, and evaluation of newborn health at delivery. Genetic testing will focus on specific gene mutations linked to ICP. The study will also gather information on related health conditions and family history. Researchers aim to identify markers for ICP prognosis and understand its impact on maternal well-being and neonatal health over the course of the pregnancy.
CONDITIONS
Brief Title
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 21 to 45 years with consistent itching
- Elevated 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 study requirements and give written informed consent
- Willing to participate until delivery and follow-up until delivery
- Agrees to provide information on perinatal and maternal outcomes at or after delivery
You will not qualify if you...
- Viral and infectious diseases such as hepatitis B, hepatitis C, Epstein Barr virus, Cytomegalovirus, HIV, and hepatitis E
- Primary skin diseases causing itching
- Metabolic diseases including alcohol abuse
- Other causes of cholestasis like primary biliary cholangitis or primary sclerosing cholangitis
- Autoimmune liver diseases
- Obstructive biliary diseases
- Drug-induced cholestatic liver injury
- Severe clinical conditions like heart failure, renal failure, or primary cardiopulmonary diseases
- Twin or triplet pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery
Participants are observed throughout their pregnancy to assess bile acid profiles, genetic mutations, and related health outcomes.
Baseline visit and follow-up at delivery
Trial Site Locations
Total: 1 location
1
Dr. Madhumita Premkumar
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
Research Team
D
Dr Madhumita Premkumar, DM
J
Jasvinder Nain, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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