Non Invasive Prenatal Testing of Down Syndrome
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 28, 2014
Trial Information
Current as of June 25, 2025
Completed
Keywords
ClinConnect 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.
The general objectives are :
* Promote the rapid and large implementation of Non Invasive Prenatal Testing (NIPT) for Down syndrome.
* Improve the management of women at risk after combined first trimester screening and reduce the number of invasive procedures and induced m...
Gender
FEMALE
Eligibility criteria
- 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Laurent J Salomon, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Michel VEKEMANS, MD, PhD
Study Director
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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