T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients
NCT ID: NCT02424474
Last Updated: 2017-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
933 participants
INTERVENTIONAL
2015-06-30
2017-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Genetic NIPT and regular serum screening
All woman will be tested using the two tests, genetic NIPT (Non Invasive Prenatal Testing) and regular serum screening.
Genetic NIPT
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
Regular serum screening
Interventions
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Genetic NIPT
Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
Regular serum screening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Having a spontaneous pregnancy or obtained by AMP ,
* Having chosen to carry out a screening of the T21 to the first or second trimester of pregnancy ,
* Gestational age \>=10 weeks of amenorrhea
* Consenting to invasive prenatal diagnosis,
* Having health insurance,
* Having signed the informed consent
Exclusion Criteria
* Participant to another biomedical research.
* Pregnancy twins including the presence of a twin vanishing
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Alexandra Benachi, MD, PhDi
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Antoine Béclère Hospital
Locations
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AP-HP, Antoine Béclère Hospital
Clamart, , France
Countries
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References
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Dabi Y, Guterman S, Jani JC, Letourneau A, Demain A, Kleinfinger P, Lohmann L, Costa JM, Benachi A. Autoimmune disorders but not heparin are associated with cell-free fetal DNA test failure. J Transl Med. 2018 Dec 3;16(1):335. doi: 10.1186/s12967-018-1705-2.
Costa JM, Letourneau A, Favre R, Bidat L, Belaisch-Allart J, Jouannic JM, Quarello E, Senat MV, Broussin B, Tsatsaris V, Demain A, Kleinfinger P, Lohmann L, Agostini H, Bouyer J, Benachi A. Cell-free fetal DNA versus maternal serum screening for trisomy 21 in pregnant women with and without assisted reproduction technology: a prospective interventional study. Genet Med. 2018 Nov;20(11):1346-1353. doi: 10.1038/gim.2018.4. Epub 2018 Mar 1.
Other Identifiers
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P141001
Identifier Type: -
Identifier Source: org_study_id
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