Early Ultrasound and Maternal Biochemical Markers to Eval... | NCT00287417

Studies
Early Ultrasound and Maternal Biochemical Markers to Evaluate the Risk of Down Syndrome During the First Trimester

NCT00287417

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

May 16, 2011Estimated

Enrollment

20,000Actual

Phase

Not provided

Conditions

Down Syndrome

Interventions

echography
blood sample

Countries

France

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

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Feb 2011Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Feb 3, 2006

First Posted Date

Feb 6, 2006Estimated

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

May 13, 2011

Last Update Posted Date

May 16, 2011Estimated

Description Module

Brief Summary

The aim of the study is to evaluate the risk of Down syndrome during the first trimester of the pregnancy. The risk assessment is evaluated using early ultrasound and maternal biochemical markers.

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

20,000Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female > 18 years old
Pregnant

Exclusion Criteria:

Maternal age < 18 years old, twin pregnancy

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

Primary care clinics, public hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Israel Nisand, MD	Hopitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg		Strasbourg	Alsace	67098	France

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
echography	Device
blood sample	Other