Serum Autotaxin Levels in Cholestasis of Pregnancy | NCT02480478

Studies
Serum Autotaxin Levels in Cholestasis of Pregnancy

NCT02480478

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jun 21, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hakan Erenel, MD, OB/GYN, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum autotaxin levels in cholestasis of pregnancy		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria:

acute or chronic liver disease
acute or chronic gallbladder disease

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hakan Erenel, MD,OBGYN	Contact	00905063092995		hakanerenel@yahoo.com

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Etfal Training and Research Hospital	Recruiting	Istanbul		34371	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
C535932	Intrahepatic Cholestasis of Pregnancy

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided