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Study of High Risk Non Invasive Prenatal Test Population

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ClinicalTrials.gov Identifier: NCT04737070
Recruitment Status : Not yet recruiting
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Matthieu DAP, Central Hospital, Nancy, France

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Trisomy 21 Biological: Prenatal test for Trisomy 21 screening

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of High Risk Non Invasive Prenatal Test Population
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Groups and Cohorts
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Intervention Details:
  • Biological: Prenatal test for Trisomy 21 screening
    prenatal routine test for Trisomy 21 screening (blood test + nuchal translucency test)

Outcome Measures
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Primary Outcome Measures :
  1. number of genetics anomalies [ Time Frame: through study completion, an average of 9 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
High risk population for prenatal screening of Trisomy 21
Criteria

Inclusion Criteria:

  • Prenatal screening of Trisomy 21 > 1/50 (high risk population)

Exclusion Criteria:

  • No exclusion criteria
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Matthieu DAP, medical doctor (MD), Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04737070    
Other Study ID Numbers: 2020PI310
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Trisomy
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn