Serum Autotaxin Levels in Cholestasis of Pregnancy

• Conditions: Intrahepatic Cholestasis of Pregnancy

• Registration Number: NCT02480478
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.

Detailed Description

Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-21
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2016-06
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria

• acute or chronic liver disease
• acute or chronic gallbladder disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum autotaxin levels in cholestasis of pregnancy	one year

Trial Locations

Locations (1)

Sisli Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey