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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06366659
Other study ID # M2024049
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date August 20, 2025

Study information

Verified date April 2024
Source Peking University
Contact Guangyi Lan
Phone 13176881226
Email guangyi_lan@stu.pku.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing
China Sichuan University West China Second University Hospital Chengdu Sichuan

Sponsors (2)

Lead Sponsor Collaborator
Peking University Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Itch intensity through questionnaire 1 year in total. At the last day of the month 9 of the pregnancy of participants.
Secondary Total bile acids (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.
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