Clinical trials: Non Invasive Prenatal Diagnosis
Down Syndrome, Edwards Syndrome
Non-Invasive Screening for Fetal Aneuploidy
The purpose of this study is to detect whole chromosome abnormalities in maternal blood.
- Trial name
- NCT02317965
- Testing
- Maternal Blood Draw
- Where
- 10 sites in United States
- Volunteers
- 340 people
- Sponsor
- Progenity, Inc.
Trisomy 13, Trisomy 18
High Risk Multiple Gestation Study
The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample.
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities
- Trial name
- NCT02278874
- Where
- 4 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Perinatal Outcomes, Preterm Birth
Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies
The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the Obstetric High Care (OHC), on…
- Conditions
- Perinatal Outcomes, Preterm Birth, High Risk Pregnancy
- Trial name
- NIEM-O (NCT06151613)
- Testing
- continuous eCTG monitoring using the NFMS
- Where
- Netherlands
- Volunteers
- 1,911 people
- Sponsor
- Maxima Medical Center
Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy
Non-invasive Prenatal Diagnostic Validation Study
The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.
- Conditions
- Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy, Chromosome 21 Aneuploidy, Sex Chromosome Aberrations
- Trial name
- NIPD (NCT01574781)
- Testing
- Blood draw, Cheek swab/Saliva Sampling
- Where
- United States
- Volunteers
- 1,781 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Prenatal Disorder, Aneuploidy
PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood
This project aims to provide high- quality evidence to inform decisions by health care organisations about using first-tier non-invasive prenatal screening (NIPS) to replace traditional screening tests for trisomy 21, and…
- Trial name
- PEGASUS-2 (NCT03831256)
- Testing
- Traditional integrated prenatal screening, Second-tier Non-invasive prenatal screening (NIPS), First-tier Non-invasive prenatal screening (NIPS)
- Where
- 6 sites in Canada
- Volunteers
- 7,849 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Trisomy 13, Trisomy 18
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial
This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA…
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Aneuploidy
- Trial name
- PreNATUS (NCT01545674)
- Testing
- Blood Draw
- Where
- 29 sites in United States, Canada and 4 more
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Trisomy 21, Trisomy 18
Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods.
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- NCT03559374
- Testing
- Vanadis NIPT system
- Where
- Italy
- Volunteers
- 1,200 people
- Sponsor
- PerkinElmer, Wallac Oy
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma.
- Conditions
- Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease, Cystic Fibrosis, Fragile X Syndrome
- Trial name
- DANNIgene (NCT06147414)
- Testing
- Blood sample
- Where
- France
- Volunteers
- 550 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Antenatal Congenital Malformations
Comparison of the Non-invasive Approach and Fetal Exome Sequencing in Prenatal Diagnosis When Fetal Ultrasound Signs Are Discovered
The discovery of congenital malformations and/or non-specific signs by ultrasound (5% of pregnancies) represents a real medical challenge.
- Trial name
- DPNI-Exome (NCT05182242)
- Testing
- Collection of clinical data, Collection of samples, Questionnaires
- Where
- France
- Volunteers
- 75 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Pregnancy
Assessment of Women's Insight and Understanding of Down's Syndrome Screening by Non-invasive Prenatal Testing (NIPT) During Their First Ultrasound
Down's syndrome is the leading cause for mental retardation in France. Screening for this chromosomal abnormality is systematically proposed during pregnancy.
- Trial name
- DEPIST21 (NCT03549286)
- Testing
- Questionnaire passation
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- CHU de Reims
Noninvasive Mucinous Cystadenocarcinoma of Ovary
Non Ivasive Prenatal Diagnosis (NIPD) of Cystic Fibrosis
The purprose of this study is to develop and validate an analytical and clinical NIPD test for cystic fibrosis from maternal blood by analysis circulating free fetal DNA (cff-DNA), searching for the paternal mutation in families…
- Trial name
- NCT02130648
- Testing
- A sampling of blood
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Cytomegalovirus Congenital
Biomarkers of Cytomegalovirus Fetal Infection and Disease
The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could be done directly in the maternal blood instead of requesting an amniocentesis and 2) if innovative technologies such as proteomic…
- Trial name
- BIO-CCMV (NCT03090841)
- Testing
- Bio-specimen collected
- Where
- France
- Volunteers
- 265 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aneuploidy, Trisomy 21
Non-Invasive Chromosomal Evaluation of Trisomy Study
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
- Conditions
- Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- NICHE (NCT02201862)
- Where
- 3 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Cindy Cisneros
Hereditary Diseases
Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling
The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary…
- Trial name
- NCT05453474
- Testing
- Whole genome amplification
- Where
- Denmark
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Aalborg University Hospital
Down Syndrome, Edwards Syndrome
Non-Invasive Screening for Fetal Aneuploidy
The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child…
- Trial name
- NCT00847990
- Testing
- Maternal blood screening test for fetal aneuploidy
- Where
- 25 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Sequenom, Inc.
Trisomy 21, Trisomy 18
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood
The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a…
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13, Sex Chromosome Abnormalities
- Trial name
- MAPS (NCT01852708)
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Trisomy 21
Non Invasive Prenatal Diagnosis of Trisomy 21 by Genetic Analysis of Circulating Fetal Cells
The objective of this project is to develop a non-invasive prenatal diagnostic test for trisomy 21 which is reliable, sensitive and cost-effective, and thus, offers an alternative to the currently employed invasive diagnostic…
- Trial name
- ISETTRI21 (NCT01725438)
- Testing
- sample blood
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Prenatal Screening, Pregnancy Related
Fetal Cell Analysis From Maternal Blood
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
- Conditions
- Prenatal Screening, Pregnancy Related, Genetic Disease
- Trial name
- NCT05671744
- Testing
- Cell-based non-invasive prenatal testing
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Menarini Biomarkers Singapore
Hereditary Disease
Non Invasive Prenatal Testing (NIPT) of Single-gene Disorders
Developing a new non-invasive prenatal test for single gene disorders from cell free fetal DNA, retrieved from the mothers blood.
- Trial name
- NCT02339402
- Where
- 2 sites in Netherlands
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Non Invasive Prenatal Diagnosis
NIPD on CFTC for Triplet Repeat Diseases
The purpose of this study is to develop and validate an analytical and clinical NIPD test for triplet repeat diseases by isolated circulating fetal trophoblastic cells (CFTC) analysis from maternal blood, searching for the…
- Trial name
- DIACCIMEX (NCT03087526)
- Testing
- Non invasive prenatal diagnosis
- Where
- 8 sites in France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier