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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02480478
Other study ID # 518
Secondary ID
Status Recruiting
Phase N/A
First received June 21, 2015
Last updated April 19, 2016
Start date June 2015
Est. completion date January 2017

Study information

Verified date April 2016
Source Sisli Etfal Training & Research Hospital
Contact Hakan Erenel, MD,OBGYN
Phone 00905063092995
Email hakanerenel@yahoo.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2017
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria:

- acute or chronic liver disease

- acute or chronic gallbladder disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Sisli Etfal Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sisli Etfal Training & Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum autotaxin levels in cholestasis of pregnancy one year No
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