Clinical trials: Non Invasive Prenatal Diagnosis
Neonatal Thrombocytopenia Isoimmunization Maternal-fetal
Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis
Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother.
- Trial name
- NCT02899598
- Testing
- Extra blood draw samples, extra amniotic fluid samples
- Where
- France
- Sponsor
- Assistance Publique Hopitaux De Marseille
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 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.
Monogenic Diseases, Genetic Diseases, Inborn
Health Economic Evaluation of Non-Invasive Prenatal Exclusion Diagnosis
Since the discovery of a small fraction of circulating cell-free fetal DNA (ccffDNA) in the blood of the mother, non-invasive prenatal diagnosis (NIPD) techniques using a simple blood sample have been developed to 1) screen for…
- Trial name
- PRENATSAFE (NCT07469657)
- Testing
- NIPD by NGS
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Fetal Distress With Antenatal Problem, Fetal Growth Retardation
Validation of Sensors for Long-term Non-Invasive Fetal Monitoring
A multidisciplinary team of a doctor and engineers have developed a new sensor that will be able to detect mothers' and babies' heartbeat and babies movements in late pregnancy.
- Trial name
- NCT06952777
- Testing
- Non-adhesive capacitively-coupled sensors
- Where
- United Kingdom
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- University of Manchester
Antenatal Depression, Major Depressive Disorder
Pilot Study of Personalized Aperiodic Transcranial Alternating Current Stimulation in Antenatal Depression (PandA-tACS)
The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.
- Conditions
- Antenatal Depression, Major Depressive Disorder, Major Depressive Disorder in Pregnancy, Healthy Controls
- Trial name
- PandA-tACS (NCT06979154)
- Testing
- tACS (aperiodic)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis
Non-invasive Prenatal Diagnosis of Monogenic Disorders by Linked-reads Technology
Description of the presence of cell-free fetal DNA in maternal plasma allowed the possibility of non-invasive prenatal diagnosis.
- Trial name
- NID (NCT03622892)
- Where
- 6 sites in France
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
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
22q11 Deletion Syndrome, DiGeorge Syndrome
SNP-based Microdeletion and Aneuploidy RegisTry (SMART)
This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and…
- Conditions
- 22q11 Deletion Syndrome, DiGeorge Syndrome, Trisomy 21, Trisomy 18
- Trial name
- SMART (NCT02381457)
- Where
- 21 sites in United States, Australia and 4 more
- Volunteers
- 20,960 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Congenital Diaphragmatic Hernia
Smart Removal for Congenital Diaphragmatic Hernia
The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia…
- Trial name
- SmartRemoval (NCT05100693)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Fetal Anomaly
Validation of a Test for Fetal Malformations
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and…
- Trial name
- NCT02965287
- Testing
- Serum metabolomics profiling
- Where
- Italy
- Volunteers
- 1,943 people, healthy volunteers welcome
- Sponsor
- Theoreo Srl
Trisomy 21
Non-invasive Chromosomal Examination of Trisomy Study
The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum…
- Trial name
- NEXT (NCT01511458)
- Where
- 36 sites in United States, Belgium and 4 more
- Volunteers
- 18,955 people
- Sponsor
- Roche Sequencing Solutions
Down Syndrome
Non Invasive Prenatal Testing of Down Syndrome
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…
- Trial name
- SAFE 21 (NCT02127515)
- Testing
- Non Invasive Prenatal Testing, Invasive Prenatal Testing
- Where
- France
- Volunteers
- 2,111 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Trisomy 21, Trisomy 18
Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood
Each year, 450,000 Canadian women become pregnant and, as a result of their participation in prenatal screening for Down syndrome, approximately 10,000 of them will have an amniocentesis (i.e.
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- PEGASUS (NCT01925742)
- Testing
- Integrated prenatal screening for Down's syndrome, Serum QUAD Assay for aneuploidy screening, Semiconductor MPSS NIPT assay using ccfDNA in maternal blood
- Where
- 5 sites in Canada
- Volunteers
- 3,819 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Pregnancy Complications
Early PrEgnancy Complications Testing
The aim of this study is the early (presymptomatic) detection of pregnancy complications, which could contribute to a preventive treatment.
- Trial name
- ExPECT (NCT04079361)
- Testing
- Blood samples
- Where
- Belgium
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
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.
Fetal Growth Restriction, Preeclampsia Severe
Expanded NIPT for Pregnancy Complications
This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including…
- Trial name
- NCT04311749
- Testing
- Expanded panel cell free DNA testing (non-invasive prenatal testing), Placental biopsy, Umbilical cord blood
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Francisco
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
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