Bile Acids Metabolism and Genetic Mutation Profile in the ICP in the Indian Population

NCT05691036 | Unknown

• 1 other identifier: 2022-2107
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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%).

Conditions

Intrahepatic Cholestasis of Pregnancy; Genetic Mutation; Health Related Quality of Life

Keywords

Intrahepatic cholestasis of pregnancy; Genetic Mutations in pregnancy associated cholestasis; Pruritus

Outcome Measures

Primary Outcomes (4)

• The baseline profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.

  Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)

  Day 0

• Change in the profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.

  Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)

  At delivery

• Role of ABCB11, ABCB4, and ATP8B1 gene mutations in women with ICP

  Targeted Next Generation sequencing will be done at baseline

  Day 0

• The HRQOL (Health-related quality of life) in patients with ICP and healthy pregnant women.

  Short form (SF) health survey questionnaire will be used to access the quality of life in ICP patients

  Day 0

Secondary Outcomes (7)

• Determine the risk of labor induction, early termination of pregnancy, and operative delivery in the cohort of women with ICP.

  At delivery

• At the baseline visit, measurement of pruritus of the visual analog scale (VAS).

  Day 0

• Change in pruritus of the visual analog scale (VAS) at delivery.

  At delivery

• Measurement of fasting bile acids, liver function test(LFT) at baseline in pregnant women with ICP.

  Day 0

• Change in fasting bile acids, liver function test(LFT) in pregnant women with ICP.

  At delivery

Study Arms (2)

Pregnant women with ICP

Case: Pregnant women with consistent pruritus or on medication for pruritus associated with an elevated level of serum transaminase alanine transaminase(ALT)\>40 IU/L or aspartate transaminase(AST)\>37 IU) and raised serum bile acids ≥10µmol/L will be eligible for the inclusion in the study.

Pregnant women without ICP

Controls: Healthy pregnant women of the same gestational age with routine physical examinations will be enrolled as a control group.

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Pregnant women aged more than 21 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study Population: Group 1: Pregnant women with ICP, n= 75 Cases: Pregnant women with consistent pruritus or on medication for pruritus associated with an elevated level of serum transaminase (ALT\>40 IU/L or AST \>37 IU) and raised serum bile acids ≥10μmol/L will be eligible for inclusion in the study. Group 2: Pregnant women without ICP, n=75 Controls: Healthy pregnant women of the same gestational age with routine physical examinations will be enrolled as a control group. Setting: PGIMER (Chandigarh, India) Study Centre - Departments of Hepatology/ Obstetrics and Gynaecology, PGIMER, Chandigarh

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr. Madhumita Premkumar

Chandigarh, 160012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

8 mL of blood will be drawn.

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Madhumita Premkumar

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Madhumita Premkumar, DM

CONTACT

7087003409; drmadhumitap@gmail.com

Jasvinder Nain, MPH

CONTACT

jasvindernain1506@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: January 19, 2023
• Study Start: December 8, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)