Study of Bile Acids and Genetic Changes in Intrahepatic Cholestasis of Pregnancy Among Indian Women

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.

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