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Serum Autotaxin Levels in Cholestasis of Pregnancy

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ClinicalTrials.gov Identifier: NCT02480478
Recruitment Status : Unknown
Verified April 2016 by Hakan Erenel, Sisli Hamidiye Etfal Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Hakan Erenel, 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.

Condition or disease
Intrahepatic 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
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : January 2017


Group/Cohort
intrahepatic cholestasis of pregnancy
5 ml whole blood sample is going to collect from intrahepatic cholestasis of pregnancy group for the assessment of serum autotaxin levels
healthy control group
5 ml of whole blood is going to taken from healthy control group



Primary Outcome Measures :
  1. Serum autotaxin levels in cholestasis of pregnancy [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
5ml whole blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients who are admitted to obstetrics and gynecology department due to cholestasis of pregnancy
Criteria

Inclusion Criteria:

  • Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480478


Contacts
Contact: Hakan Erenel, MD,OBGYN 00905063092995 hakanerenel@yahoo.com

Locations
Turkey
Sisli Etfal Training and Research Hospital Recruiting
Istanbul, Turkey, 34371
Contact: Hakan Erenel, MD, OB/GYN    00905063092995    hakanerenel@yahoo.com   
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
Study Director: Hakan Erenel, MD,OBGYN Sisli Etfal Training and Research Hospital

Responsible Party: Hakan Erenel, MD, OB/GYN, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02480478     History of Changes
Other Study ID Numbers: 518
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Hakan Erenel, Sisli Hamidiye Etfal Training and Research Hospital:
Intrahepatic Cholestasis of Pregnancy

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases