The Type of Hepatoglobin in IUGR | NCT02127385

Studies
The Type of Hepatoglobin in IUGR

NCT02127385

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Apr 30, 2014Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Haptoglobin Type

Interventions

Not provided

Countries

Not provided

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2015Estimated

Completion Date

Not provided

First Submitted Date

Apr 29, 2014

First Submission Date that Met QC Criteria

Apr 29, 2014

First Posted Date

Apr 30, 2014Estimated

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 29, 2014

Last Update Posted Date

Apr 30, 2014Estimated

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

Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp 2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp 2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common and severe in the Hp 2-2 genotype with the less anti oxidant properties.

Detailed Description

Not provided

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

200Estimated

Label	Type	Description	Intervention Names
IUGR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
type of haptoglobin	severity of iugr	10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Pregnancies complicated with IUGR -

Exclusion Criteria: NOT INTERESTED DO PARTICIPATE

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients adimitted with IUGR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RON BELOOSESKY, M.D	HILLEL YAFFE MEDICAL CENTER- TECHNION	Principal Investigator

Locations

Not provided