NCT02480478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

June 21, 2015

Last Update Submit

April 19, 2016

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Intrahepatic Cholestasis of Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Serum autotaxin levels in cholestasis of pregnancy

    one year

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who are admitted to obstetrics and gynecology department due to cholestasis of pregnancy

You may qualify if:

  • Clinical diagnosed cholestasis of pregnancy patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

5ml whole blood sample

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Study Officials

  • Hakan Erenel, MD,OBGYN

    Sisli Etfal Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Hakan Erenel, MD,OBGYN

CONTACT

00905063092995hakanerenel@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, OB/GYN

Study Record Dates

First Submitted

June 21, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

TU(1)