Serum Autotaxin Levels in Cholestasis of Pregnancy

Brief Title

Serum Autotaxin Levels in Cholestasis of Pregnancy

Official Title

Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy

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 Type

Observational


Primary Outcome

Serum autotaxin levels in cholestasis of pregnancy


Condition

Intrahepatic Cholestasis of Pregnancy


Study Arms / Comparison Groups

 intrahepatic cholestasis of pregnancy
Description:  5 ml whole blood sample is going to collect from intrahepatic cholestasis of pregnancy group for the assessment of serum autotaxin levels

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

June 2015

Completion Date

January 2017

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosed cholestasis of pregnancy patients

        Exclusion Criteria:

          -  acute or chronic liver disease

          -  acute or chronic gallbladder disease
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hakan Erenel, MD,OBGYN, 00905063092995, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT02480478

Organization ID

518


Responsible Party

Principal Investigator

Study Sponsor

Sisli Hamidiye Etfal Training and Research Hospital


Study Sponsor

Hakan Erenel, MD,OBGYN, Study Director, Sisli Etfal Training and Research Hospital


Verification Date

April 2016