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NCT04737070 Clinical Trial

Study of High Risk Non Invasive Prenatal Test Population

Trisomy 21 Clinical Trial

Official title:
Study of High Risk Non Invasive Prenatal Test Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04737070
Other study ID # 2020PI310
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date July 1, 2021

Study information
Verified date January 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigator want to study the population of high risk (over 1/50) of Trisomy 21. According to french guidelines, these patients needs to have a invasive test (such as amniocentesis) but some patients prefer to have a Non Invasive Prenatal Test, with a potential lack of information.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date July 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Prenatal screening of Trisomy 21 > 1/50 (high risk population) Exclusion Criteria: - No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Prenatal test for Trisomy 21 screening
prenatal routine test for Trisomy 21 screening (blood test + nuchal translucency test)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary number of genetics anomalies through study completion, an average of 9 months
See also
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