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Early Ultrasound and Maternal Biochemical Markers to Evaluate the Risk of Down Syndrome During the First Trimester
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, November 2008
First Received: September 13, 2005   Last Updated: November 7, 2008   History of Changes
Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00287417
  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

Genetics Home Reference related topics: Down syndrome
MedlinePlus related topics: Down Syndrome Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Nuchal Translucency Study - PAPP-A

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

Estimated Enrollment: 15000
Study Start Date: July 2003
  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

Contacts
Contact: Israel Nisand, MD 33388127456 israel.nisand@chru-strasbourg.fr
Contact: Romain Favre, MD 33388628329 romain.favre@chru-strasbourg.fr

Locations
France
Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique Recruiting
COLMAR, France, 68024
Contact: Richard KUTNAHORSKY, MD     33.3.89.12.60.92     kutnahorsky@mac.com    
Principal Investigator: Richard KUTNAHORSKY, MD            
Centre de Périnatalité, Hôpital Civil Recruiting
GUEBWILLER, France, 68500
Contact: Richard KUTNAHORSKY, MD     33.3.89.74.78.05     kutnahorsky@mac.com    
Principal Investigator: Richard KUTNAHORSKY, MD            
Centre Hospitalier Recruiting
BELFORT, France, 90000
Contact: Gilles LEVY, MD     33.3.84.57.40.00     gilles.levy@wanadoo.fr    
Principal Investigator: Gilles LEVY, MD            
Clinique ADASSA Recruiting
STRASBOURG, France, 67000
Contact: Isabelle TISSIER, MD            
Principal Investigator: Isabelle TISSIER, MD            
Centre Hospitalier du Hasenrain Recruiting
MULHOUSE, France, 68051
Contact: YOHNY MONTOYA, MD     33389646464        
Principal Investigator: Yohny MONTOYA, MD            
France, Alsace
Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, Alsace, France, 67098
Contact: Nisand Israel, MD     33388628329     israel.nisand@chru-strasbourg.fr    
Principal Investigator: Israël NISAND, MD            
Sub-Investigator: Romain FAVRE, MD            
Sub-Investigator: Brigitte VIVILLE, MD            
Service de Gynécologie-Obstétrique, SIHCUS, CMCO Recruiting
Strasbourg, Alsace, France, 67303
Contact: Favre Romain, MD     33388628329     romain.favre@chru-strasbourg.fr    
Principal Investigator: Romain FAVRE, MD            
Sub-Investigator: Monique FINKBEINER-KOHLER, MD            
Sub-Investigator: Christophe VAYSSIERE, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Israel Nisand, MD Hopitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI )
Study ID Numbers: 3032
Study First Received: September 13, 2005
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00287417     History of Changes
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Mental Retardation
Genetic Diseases, Inborn
Chromosome Disorders
Abnormalities, Multiple
Neurologic Manifestations
Down Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

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

ClinicalTrials.gov processed this record on May 07, 2009