Status:
COMPLETED
High Risk Multiple Gestation Study
Lead Sponsor:
Natera, Inc.
Collaborating Sponsors:
MOUNT SINAI HOSPITAL
Montefiore Medical Center
Conditions:
Trisomy 13
Trisomy 18
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy fro...
Eligibility Criteria
Inclusion
- Age 18 or older at enrollment
- Clinically confirmed multiple gestation pregnancy
- Pregnancy at high risk for genetic aneuploidy as defined below:
- Confirmed positive aneuploidy by invasive testing
- Non invasive prenatal testing "high risk" result
- Serum screening risk of greater than 1:100
- Ultrasound abnormalities indicative of aneuploidy
- Structural abnormality of the posterior fossa
- Holoprosencephaly
- Structural cardiac anomaly
- Omphalocele
- Nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater Hydrops of unknown etiology
- Age ≥ 38 years at delivery (if serum screening risk is not less than 1:100)
- Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
- Able to provide informed consent
Exclusion
- Women carrying singleton pregnancy
- Surrogate or egg donor used
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02278874
Start Date
August 1 2014
End Date
March 1 2019
Last Update
June 13 2019
Active Locations (4)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Long Island Jewish Medical Center
Glen Cove, New York, United States, 11542
3
Mt. Sinai Hospital
New York, New York, United States, 10029
4
Montefiore Medical Center
The Bronx, New York, United States, 10461