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.
Study Type
OBSERVATIONAL
Enrollment
354
Natera, Inc.
San Carlos, California, United States
San Diego Perinatal Center
San Diego, California, United States
Carnegie Hill Imaging for Women
New York, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Office of Dr. Robert Carpenter
Houston, Texas, United States
Houston Perinatal Associates
Houston, Texas, United States
Bangalore Fetal Medicine Centre
Bangalore, India
Fetal Medicine & Gynaecology Centre
Petaling Jaya, Selangor, Malaysia
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.'
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.
Time frame: 2 years
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