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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00287417
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Down Syndrome Device: echography Other: blood sample

Study Design

Study Type : Observational
Actual Enrollment : 20000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nuchal Translucency Study - PAPP-A
Study Start Date : July 2003
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics, public hospitals
Criteria

Inclusion Criteria:

  • Female > 18 years old
  • Pregnant

Exclusion Criteria:

  • Maternal age < 18 years old, twin pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287417


Locations
France
Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France, 67098
Service de Gynécologie-Obstétrique, SIHCUS, CMCO
Strasbourg, Alsace, France, 67303
Centre Hospitalier
Belfort, France, 90000
Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique
Colmar, France, 68024
Centre de Périnatalité, Hôpital Civil
Guebwiller, France, 68500
Centre Hospitalier du Hasenrain
Mulhouse, France, 68051
Clinique ADASSA
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Israel Nisand, MD Hopitaux Universitaires de Strasbourg
More Information

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint de la DRCI, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00287417     History of Changes
Other Study ID Numbers: 3032
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by University Hospital, Strasbourg, France:
Nucal translucency
Down syndrome
MSS
Risk assessment

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn