CompletedNot Applicable

Non Invasive Prenatal Testing of Down Syndrome

France2,111 participantsStarted 2014-04-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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

Inclusion Criteria: * pregnant women over 18 * at risk for Down syndrome\> 1/250 based on combined screening using ultrasound together with maternal serum markers and prior to fetal karyotyping * singleton pregnancy * pregnancy between 11SA et 18SA * willing a fetal karyotype Exclusion Criteria: * risk for Down syndrome\< 1/250 or \>1/5 * NT\> 3 mm, PAPP-A or beta HCG \<0.3 MoM or \>5 MoM * multiple pregnancy , vanishing twin * morphological abnormalities at US * Kown chromosomal anomaly in parents * Patients not willing a fetal karyotype

What they're measuring

Number or miscarriages

Timeframe: at birth

Trial details

NCT IDNCT02127515

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11-07

View on ClinicalTrials.gov More Down Syndrome trials