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NCT00287417 Clinical Trial

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

Down Syndrome Clinical Trial

Official title:
Nuchal Translucency Study - PAPP-A

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00287417
Other study ID # 3032
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated May 13, 2011
Start date July 2003
Est. completion date February 2011

Study information
Verified date May 2011
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20000
Est. completion date February 2011
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female > 18 years old

- Pregnant

Exclusion Criteria:

- Maternal age < 18 years old, twin pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• echography

Other:
• blood sample

Locations
Country Name City State
France Centre Hospitalier Belfort
France Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique Colmar
France Centre de Périnatalité, Hôpital Civil Guebwiller
France Centre Hospitalier du Hasenrain Mulhouse
France Clinique ADASSA Strasbourg
France Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Strasbourg Alsace
France Service de Gynécologie-Obstétrique, SIHCUS, CMCO Strasbourg Alsace

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

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