Serum Autotaxin Levels in Cholestasis of Pregnancy

NCT ID: NCT02480478

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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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

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

Conditions

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Intrahepatic Cholestasis of Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

healthy control group

5 ml of whole blood is going to taken from healthy control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria

* acute or chronic liver disease
* acute or chronic gallbladder disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hakan Erenel

MD, OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Erenel, MD,OBGYN

Role: STUDY_DIRECTOR

Sisli Etfal Training and Research Hospital

Locations

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Sisli Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hakan Erenel, MD,OBGYN

Role: CONTACT

00905063092995

Facility Contacts

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Hakan Erenel, MD, OB/GYN

Role: primary

00905063092995

Other Identifiers

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518

Identifier Type: -

Identifier Source: org_study_id

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