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

NCT ID: NCT00287417

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Down Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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echography

Intervention Type DEVICE

blood sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female \> 18 years old
* Pregnant

Exclusion Criteria

* Maternal age \< 18 years old, twin pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Strasbourg, France

Principal Investigators

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Israel Nisand, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Universitaires de Strasbourg

Locations

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

Strasbourg, Alsace, France

Site Status

Service de Gynécologie-Obstétrique, SIHCUS, CMCO

Strasbourg, Alsace, France

Site Status

Centre Hospitalier

Belfort, , France

Site Status

Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique

Colmar, , France

Site Status

Centre de Périnatalité, Hôpital Civil

Guebwiller, , France

Site Status

Centre Hospitalier du Hasenrain

Mulhouse, , France

Site Status

Clinique ADASSA

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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3032

Identifier Type: -

Identifier Source: org_study_id

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