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
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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