T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients

NCT02424474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 933

Last updated 2017-08-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.

Conditions

  • Trisomy 21, 18 and 13 Screening

Interventions

DEVICE

Genetic NIPT

Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.

BIOLOGICAL

Regular serum screening

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexandra Benachi, MD, PhDi · AP-HP, Antoine Béclère Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-30
Completion
2017-02-14

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 NCT02424474 on ClinicalTrials.gov