Multiple Gestation Study
Completed
Conditions studied: Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities
In brief
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.
Key facts
- Study ID
- NCT02278536
- Run by
- Natera, Inc.
- People needed
- 354
- Starts
- 2013-03-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-08-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Women carrying singleton pregnancy
- Surrogate or egg donor used
Where it is running
- 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
Full record on ClinicalTrials.gov
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