Study Stopped
Non-invasive Prenatal Screening CLIA test performance validated in other cohort. Decided samples not required, study aims achieved through other studies.
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial
PreNATUS
2 other identifiers
observational
937
6 countries
29
Brief Summary
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 in the maternal blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 23, 2023
March 1, 2023
2.2 years
March 1, 2012
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y.
The primary objective is to determine the diagnostic capability of the test to detect autosomal aneuploidy (chromosomes 13, 18, 21) and sex aneuploidy (X and Y).
Between first trimester screening (10-14 weeks GA) and invasive testing (amniocentesis or CVS).
Study Arms (1)
Pregnant Women Blood Draw
Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw
Interventions
Eligibility Criteria
Pregnant Women
You may qualify if:
- Singleton pregnancy
- Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
- Mother has a high or moderate risk for trisomy
- Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure
You may not qualify if:
- Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
- Egg donor used
- Mother or father have known chromosomal abnormalities (including known balanced translocations)
- Participation in the study in a previous pregnancy
- Pregnancy is a result of IVF with pre-implantation genetic diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Natera, Inc.lead
- Columbia Universitycollaborator
- George Washington Universitycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (29)
University of Alabama
Birmingham, Alabama, 35233, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center
San Francisco, California, 94110, United States
Stanford University
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06510, United States
University of Miami
Miami, Florida, 33136, United States
Adventist Hinsdale Hospital
Hinsdale, Illinois, 60521, United States
Indiana University
Indianapolis, Indiana, 46207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02111, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
NY Methodist Hospital
Brooklyn, New York, 11215, United States
Madonna Perinatal
Mineola, New York, 11501, United States
New York University
New York, New York, 10016, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Carnegie Imaging for Women
New York, New York, 10128, United States
Montefiore Medical Center
New York, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28232, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Wisconsin
Madison, Wisconsin, 53715, United States
Mt Sinai Hospital
Toronto, Canada
Royal College of Surgeons in Ireland
Dublin, Ireland
University of Perugia
Perugia, Italy
Hamchoon Women's Clinic
Seoul, South Korea
Institut Universitari Dexeus
Barcelona, Spain
Biospecimen
Plasma Sample Prepared DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Wapner, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 7, 2012
Study Start
January 1, 2012
Primary Completion
April 1, 2014
Study Completion
March 1, 2023
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
A peer reviewed publication is planned from this study.