Health Condition 1: O266- Liver and biliary tract disordersin pregnancy, childbirth and the puerperium
Conditions
Interventions
None listed
Sponsors
Research Committee All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Cases: Pregnant women with singleton fetus having gestational age upto 36 weeks with ICP (pruritus not associated with other dermatosis, and/or elevated serum transaminase), willing to participate in the study will be enrolled as cases. Controls: 50 Non-pregnant age matched women along with 50 pregnant women upto 36 weeks of gestation with normal LFTs not having pruritus and no history of any liver disorder, willing to participate in the study, will be enrolled as controls.
Exclusion criteria
Exclusion criteria: For cases: 1. Acute or chronic hepatitis infection (hepatitis A, B or C) 2. Other non-viral hepatitis etiologies 3. Autoimmune hepatitis 4. Extrahepatic biliary obstruction, following ultrasound examination. 5. History of liver dysfunction or any complication in the current or previous pregnancies. 6. Having pruritus due to other dermatosis. 7. Twin or multifetal gestation 8. Not willing to participate in the study For controls: 1. Pregnant patients having pre-eclampsia 2. Patients with above as cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serum Autotaxin and serum bile acid levels in both cases and controls. 2. Comparison of serum autotaxin levels with total serum bile acids in ICP. Timepoint: 1. 1st 6 months: Recruitment of patients, Sample collection and storage. 2. Next 12 months: Recruitment of patient, Sample collection, storage, Estimation of serum Autotaxin and follow up studies. 3. Last 6 months: - Analysis of data by statistical methods - Compilation of results - Preparation of manuscripts and publication of results - Preparation of project completion report | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Correlation of serum Autotaxin and serum total bile acids with severity of disease. 2.Correlation of serum Autotaxin and serum total bile acids with maternal and fetal outcome Timepoint: 1. 1st 6 months: Recruitment of patients, Sample collection and storage. 2. Next 12 months: Recruitment of patient, Sample collection, storage, Estimation of serum Autotaxin and follow up studies. 3. Last 6 months: - Analysis of data by statistical methods - Compilation of results - Preparation of manuscripts and publication of results - Preparation of project completion report | — |
Countries
India
Contacts
Public ContactSONIYA DHIMAN
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
Outcome results
None listed