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NCT06366659

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

Sponsor: Peking University

View on ClinicalTrials.gov

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

Locations (2)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Sichuan University West China Second University Hospital

Chengdu, Sichuan, China