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New study seeks clues to mysterious pregnancy itching disorder

NCT ID NCT05691036

Knowledge-focused Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why some pregnant women develop intrahepatic cholestasis of pregnancy (ICP), a liver condition causing severe itching and higher risks for both mother and baby. Researchers will measure bile acids and check for genetic changes in 150 Indian women with and without ICP. The goal is to better understand what causes ICP and improve how it is diagnosed and managed.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

21 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intrahepatic cholestasis of pregnancy Pruritus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genetic mutation Health related quality of life Intrahepatic cholestasis of pregnancy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Dr. Madhumita Premkumar

    RECRUITING

    Chandigarh, Chandigarh, 160012, India

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