Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)
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ClinicalTrials.gov Identifier: NCT01545674 |
Recruitment Status :
Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : August 26, 2019
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Condition or disease | Intervention/treatment |
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Trisomy 13 Trisomy 18 Trisomy 21 Aneuploidy | Procedure: Blood Draw |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS) |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | December 2020 |

Group/Cohort | Intervention/treatment |
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Pregnant Women Blood Draw
Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw
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Procedure: Blood Draw
Blood will be drawn from the mother and father |
- Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y. [ Time Frame: Between first trimester screening (10-14 weeks GA) and invasive testing (amniocentesis or CVS). ]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).
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545674

Principal Investigator: | Ronald Wapner, MD | Columbia University |
Responsible Party: | Natera, Inc. |
ClinicalTrials.gov Identifier: | NCT01545674 |
Other Study ID Numbers: |
GSN012B 1R44HD062114 ( U.S. NIH Grant/Contract ) |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | August 26, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | A peer reviewed publication is planned from this study. |
Aneuploidy Non-invasive Prenatal Diagnosis Prenatal Blood Test Prenatal Aneuploidy Screening Trisomy 13 Trisomy 18 |
Trisomy 21 Trisomy Down Syndrome Turner Syndrome Edwards Syndrome |
Down Syndrome Trisomy 13 Syndrome Trisomy 18 Syndrome Aneuploidy Trisomy Chromosome Aberrations Pathologic Processes Chromosome Duplication Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |