Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

NCT06366659 | Not Yet Recruiting

• 1 other identifier: M2024049
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

diagnosis; prediction; prognosis

Outcome Measures

Primary Outcomes (2)

• Progesterone metabolites (levels in plasma)

  Analyze the plasma samples through HPLC-MS

  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

  through questionnaire

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

Secondary Outcomes (1)

• Total bile acids (levels in plasma)

  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.

Study Arms (2)

ICP patients

None intervention

Healthy pregnant women

None intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants including ICP patients and healthy pregnant women without other complications will be collected form Peking University Third Hospital and Sichuan University West China Second University Hospital.

You may qualify if:

• Pruritus in pregnancy
• Elevated levels of serum alanine aminotransferase (ALT) activities and total bile acids (TBA)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Peking University Third Hospital: collaborator

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

Sichuan University West China Second University Hospital

Chengdu, Sichuan, 610001, China

Location

Related Publications (2)

• Abu-Hayyeh S, Ovadia C, Lieu T, Jensen DD, Chambers J, Dixon PH, Lovgren-Sandblom A, Bolier R, Tolenaars D, Kremer AE, Syngelaki A, Noori M, Williams D, Marin JJ, Monte MJ, Nicolaides KH, Beuers U, Oude-Elferink R, Seed PT, Chappell L, Marschall HU, Bunnett NW, Williamson C. Prognostic and mechanistic potential of progesterone sulfates in intrahepatic cholestasis of pregnancy and pruritus gravidarum. Hepatology. 2016 Apr;63(4):1287-98. doi: 10.1002/hep.28265. Epub 2015 Dec 28.

  PMID: 26426865 BACKGROUND

• De Borre M, Che H, Yu Q, Lannoo L, De Ridder K, Vancoillie L, Dreesen P, Van Den Ackerveken M, Aerden M, Galle E, Breckpot J, Van Keirsbilck J, Gyselaers W, Devriendt K, Vermeesch JR, Van Calsteren K, Thienpont B. Cell-free DNA methylome analysis for early preeclampsia prediction. Nat Med. 2023 Sep;29(9):2206-2215. doi: 10.1038/s41591-023-02510-5. Epub 2023 Aug 28.

  PMID: 37640858 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yulong Li

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangyi Lan

CONTACT

13176881226; guangyi_lan@stu.pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: April 20, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)