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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.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00287417
First received: September 13, 2005
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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:

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

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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: May 13, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Down Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013