UnknownNot Applicable

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

China600 participantsStarted 2024-04-20

Plain-language summary

This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pruritus in pregnancy * Elevated levels of serum alanine aminotransferase (ALT) activities and total bile acids (TBA) * Exclusion of other causes of liver dysfunction or itching Exclusion Criteria: * Pruritus with skin lesions such as eczema * Pruritus of other liver-related diseases (PBC, Primary Sclerosing Cholangitis (PSC), etc.) * Twin pregnancy * TBA and pruritus did not relieve 4-6 weeks after delivery.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progesterone metabolites (levels in plasma)

Timeframe: 1 year in total. Plasma samples will be collected every 3 months during the whole pregnancy of every participant. About at the last day of the month 3, month 6, and month 9 of the whole pregnancy, respectively.

Itch intensity

Timeframe: 1 year in total. At the last day of the month 9 of the pregnancy of participants.

Trial details

NCT IDNCT06366659

SponsorPeking University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-20

Contact for this trial

Guangyi Lan

13176881226 guangyi_lan@stu.pku.edu.cn

View on ClinicalTrials.gov More Intrahepatic Cholestasis of Pregnancy trials