[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492353":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Pregnant women with ICP",null,"Case: Pregnant women with consistent pruritus or on medication for pruritus associated with an elevated level of serum transaminase alanine transaminase(ALT)\\>40 IU\u002FL or aspartate transaminase(AST)\\>37 IU) and raised serum bile acids ≥10µmol\u002FL will be eligible for the inclusion in the study.",{"label":13,"type":10,"description":14,"interventionNames":10},"Pregnant women without ICP","Controls: Healthy pregnant women of the same gestational age with routine physical examinations will be enrolled as a control group.",[16],{"name":17,"affiliation":18,"role":19},"Madhumita Premkumar","PGIMER, Chandigarh","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Dr Madhumita Premkumar, DM","CONTACT","7087003409","drmadhumitap@gmail.com",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Jasvinder Nain, MPH","jasvindernain1506@gmail.com",[30],{"facility":31,"status":32,"city":33,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Dr. Madhumita Premkumar","RECRUITING","Chandigarh","160012","India","IN",{"type":38,"coordinates":39},"Point",[40,41],76.7884,30.73629,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":10,"email":25},"Dr. Madhumita Premkumar, MD","+9101722754777",{"type":19,"investigatorFullName":17,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"ASSOCIATE PROFESSOR","100492353","bile-acids-metabolism-and-genetic-mutation-profile-in-the-intrahepatic-cholestasis-of-pregnacy-in-indian-population-100492353",false,"NCT05691036","Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population","Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in Indian Population- A Prospective Study","ICP","Inclusion Criteria -\n\n* Age \\> 21 years with consistent pruritus\n* Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \\> 40 U\u002FL or AST \\> 37 U\u002FL) or raised total serum bile acids (≥ 10 µmol\u002FL)\n* 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\n* Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery\n* Agrees to provide information on perinatal and maternal outcomes at or after delivery\n\nExclusion Criteria:\n\n* 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)\n* Primary dermatologic diseases associated with pruritus\n* Metabolic diseases (including alcohol abuse)\n* Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)\n* Autoimmune liver disease\n* Obstructive biliary diseases\n* Cholestatic drug-induced liver injury\n* Clinical severe conditions that may affect outcomes include heart failure, renal failure, primary cardiopulmonary diseases\n* Twins and triplet pregnancy",true,"FEMALE","21 Years","45 Years",{"count":62,"type":63},150,"ESTIMATED","OBSERVATIONAL","Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol\u002FL (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%).",[67,68,69],"Intrahepatic Cholestasis of Pregnancy","Genetic Mutation","Health Related Quality of Life",[71,72,73],"Intrahepatic cholestasis of pregnancy","Genetic Mutations in pregnancy associated cholestasis","Pruritus","2026-05-13",{"date":76,"type":77},"2026-05-18","ACTUAL",{"date":79,"type":77},"2022-12-08",{"date":81,"type":63},"2026-07",{"name":5,"class":6},1]