Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Recruiting
Observational Study
Intrahepatic Cholestasis of Pregnancy
Genetic Mutation
Health Related Quality of Life
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 21 – 45
- Sex
- Female
- Study type
- Observational
- Participants needed
- 150 (estimated)
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh · Other
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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 …
Trial Locations
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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 …
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