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Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy
Sponsor: Peking University
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2024-04-20
Completion Date
2025-08-20
Last Updated
2024-04-16
Healthy Volunteers
Yes
Conditions
Locations (2)
Peking University Third Hospital
Beijing, Beijing Municipality, China
Sichuan University West China Second University Hospital
Chengdu, Sichuan, China