NCT01898832

Brief Summary

The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic 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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

July 9, 2013

Last Update Submit

March 16, 2014

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Cholestasis, pregnant, interleukin 17

Outcome Measures

Primary Outcomes (1)

  • il-17 levels

    12 months

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The pregnant women with intrahepatic cholestasis who admitted our clinic

You may qualify if:

  • Clinical diagnosis of ICP

You may not qualify if:

  • multiple pregnancies known chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak

Ankara, Ankara, 06080, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: NONE RETAINED

maternal venous ad umbilical cordon blood

MeSH Terms

Conditions

Intrahepatic Cholestasis of PregnancyCholestasis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • ayse kirbas, md

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ayse kirbas, md

CONTACT

+ 90 533 646 92 13ayseozdemirkirbas@hotmail.com

ayse kirbas

CONTACT

+90 312-306-5000

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ayse kirbas

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 18, 2014

Record last verified: 2013-07

Locations

TU(1)