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Non Invasive Prenatal Testing of Down Syndrome

NCT02127515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2111

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a randomized controlled trial in women at risk following combined prenatal screening for Down Syndrome. Women will be asked about their preferences between NIPT and routine prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between NIPT and standard invasive prenatal diagnosis.

Conditions

  • Down Syndrome

Interventions

PROCEDURE

Non Invasive Prenatal Testing

PROCEDURE

Invasive Prenatal Testing

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurent J Salomon, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Michel VEKEMANS, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-08
Primary Completion
2016-11-07
Completion
2016-11-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127515 on ClinicalTrials.gov