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NCT02278536 · ClinicalTrials.gov registry record
Multiple Gestation Study
A clinical trial of Trisomy 21 and Trisomy 18, sponsored by Natera.
- Completed
- Registry status
- 354
- Enrollment target
- 8
- Study locations
NCT02278536: Completed study of Trisomy 21 and Trisomy 18, sponsored by Natera.
NCT02278536 is a study of Trisomy 21 and Trisomy 18 that has completed, run by Natera. The registered enrollment target is 354 participants, below the 796-participant average among 5 other Trisomy 21 trials with a reported enrollment target (56% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02278536, a study of Trisomy 21 and Trisomy 18, has completed, sponsored by Natera.
- COMPLETED
- Registry status
- 354 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (8)
California
- Natera, Inc. - San Carlos
- San Diego Perinatal Center - San Diego
Texas
- Office of Dr. Robert Carpenter - Houston
- Houston Perinatal Associates - Houston
New York
- Carnegie Hill Imaging for Women - New York
North Carolina
- Lyndhurst Clinical Research - Winston-Salem
Other
- Bangalore Fetal Medicine Centre - Bangalore
Selangor
- Fetal Medicine & Gynaecology Centre - Petaling Jaya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2013-03 |
| Est. Completion | 2019-03 |
What the finished NCT02278536 record still lists
NCT02278536 is an observational study that tracks outcomes without assigning an intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 796-participant average among 5 other Trisomy 21 trials with a reported enrollment target (56% lower).
The record links to 4 conditions, with Trisomy 21 appearing as the primary indexed condition, and to 0 interventions.
NCT02278536 lists 8 locations in 6 states (California, Texas, New York).
Frequently Asked Questions
What is clinical trial NCT02278536 about?
NCT02278536 is a clinical study titled "Multiple Gestation Study". 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 mi...
What is the current status of trial NCT02278536?
This trial is currently completed. The enrollment target is 354 participants. The study started on 2013-03. Estimated completion is 2019-03.
What conditions does trial NCT02278536 study?
This clinical trial studies the following conditions: Trisomy 21, Trisomy 18, Trisomy 13, Sex Chromosome Abnormalities.
Who is sponsoring clinical trial NCT02278536?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02278536 being conducted?
This trial has 8 study locations across California, New York, North Carolina, Texas, Selangor. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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