Evaluation of itching during pregnancy
Phase 4
Completed
- Conditions
- Health Condition 1: null- Pregnant women diagnosed with intrahepatic cholestasis of pregnancy
- Registration Number
- CTRI/2017/12/010797
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 71
Inclusion Criteria
Pregnant women diagnosed with Intrahepatic Cholestasis of Pregnancy (ICP) (i.e. patients with pruritis with or without jaundice; in absence of other hepatic and dermatological causes)
Exclusion Criteria
Pruritus in pregnancy due to other causes, autoimmune liver diseases, gall bladder stone and viral hepatitis
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum bile acid levels in ICP women versus pregnant controls with no co-morbidity and non pregnant controlsTimepoint: Baseline and at 4 weeks after treatment
- Secondary Outcome Measures
Name Time Method Maternal and perinatal outcomeTimepoint: 4 weeks after treatment