NCT00287417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

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, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

First QC Date

September 13, 2005

Last Update Submit

May 13, 2011

Conditions

Down Syndrome

Keywords

Nucal translucencyDown syndromeMSSRisk assessment

Interventions

echographyDEVICE
blood sampleOTHER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinics, public hospitals

You may qualify if:

  • Female \> 18 years old
  • Pregnant

You may not qualify if:

  • Maternal age \< 18 years old, twin pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67098, France

Location

Service de Gynécologie-Obstétrique, SIHCUS, CMCO

Strasbourg, Alsace, 67303, France

Location

Centre Hospitalier

Belfort, 90000, France

Location

Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique

Colmar, 68024, France

Location

Centre de Périnatalité, Hôpital Civil

Guebwiller, 68500, France

Location

Centre Hospitalier du Hasenrain

Mulhouse, 68051, France

Location

Clinique ADASSA

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

UltrasonographyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Israel Nisand, MD

    Hopitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

February 6, 2006

Study Start

July 1, 2003

Study Completion

February 1, 2011

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

FR(7)