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

This study has been completed.
Information provided by:
University Hospital, Strasbourg, France Identifier:
First received: September 13, 2005
Last updated: May 13, 2011
Last verified: May 2011
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 Intervention
Down Syndrome
Device: echography
Other: blood sample

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nuchal Translucency Study - PAPP-A

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Enrollment: 20000
Study Start Date: July 2003
Study Completion Date: February 2011

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

Inclusion Criteria:

  • Female > 18 years old
  • Pregnant

Exclusion Criteria:

  • Maternal age < 18 years old, twin pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00287417

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
Principal Investigator: Israel Nisand, MD Hopitaux Universitaires de Strasbourg
  More Information

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint de la DRCI, University Hospital, Strasbourg, France Identifier: NCT00287417     History of Changes
Other Study ID Numbers: 3032
Study First Received: September 13, 2005
Last Updated: May 13, 2011

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

Additional relevant MeSH terms:
Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn processed this record on April 27, 2017