CompletedNot Applicable

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

France933 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>18 * 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: * The Patients whose fetus has an abnormality on the first trimester ultrasound including nuchal translucency \> 3.5mm , * Participant to another biomedical research. * Pregnancy twins including the presence of a twin vanishing

What they're measuring

Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening

Timeframe: Between the 11th and the 13th week of amenorrhea

Trial details

NCT IDNCT02424474

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Trisomy 21, 18 and 13 Screening trials