Measurement of Echogenic Area in the Border of the Fetal... | NCT01178606

Studies
Measurement of Echogenic Area in the Border of the Fetal Ventricles

NCT01178606

Sponsor

Meir Medical Center

Status

Withdrawn

Last Update Posted

Aug 28, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Israel

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2011Estimated

Completion Date

Feb 2011Actual

First Submitted Date

Aug 8, 2010

First Submission Date that Met QC Criteria

Aug 9, 2010

First Posted Date

Aug 10, 2010Estimated

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

Aug 27, 2013

Last Update Posted Date

Aug 28, 2013Estimated

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

Sonographic coronal section in the lateral fetal ventricles shows echogenic area in the ventricles borders creating an "halo" around the ventricles. Histologically this area correlates to the Stratified transitional field. In this study we would like to measure this area for the purpose of creating a nomogram.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women 22-37 GA
well dated pregnancy
singleton pregnancy

Exclusion Criteria:

no first trimester dating
multifetal pregnancy
known CNS abnormalities in the fetus
small for gestational age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Weeks

Maximum Age

37 Weeks

Standard Ages

Child

Study Population

pregnant women 22-37GA, singleton normal pregnancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba			Israel