Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in… (NCT05691036) | Clinical Trial Compass
RecruitingNot Applicable
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
India150 participantsStarted 2022-12-08
Plain-language summary
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 from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).
Who can participate
Age range
21 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.
Timeframe: At Enrolment
2
Change in the profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.
Timeframe: At Delivery
Trial details
NCT IDNCT05691036
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh