Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Trisomy 13
- Sponsor
- Natera, Inc.
- Enrollment
- 354
- Locations
- 8
- Primary Endpoint
- The primary outcome will be to confirm the diagnostic capability of NATUS risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 or older at enrollment
- •Clinically confirmed multiple gestation pregnancy
- •Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
- •Able to provide informed consent
Exclusion Criteria
- •Women carrying singleton pregnancy
- •Surrogate or egg donor used
Outcomes
Primary Outcomes
The primary outcome will be to confirm the diagnostic capability of NATUS risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'
Time Frame: 2 years
The chromosomal status will be determined from the CVS or amniocentesis results, if available. A cheek swab or saliva sample will be collected from live-born children if there are no CVS or amniocentesis results.