High Risk 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 proprietary algorithm 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 other currently available screening tests. This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

Key facts

Study ID

NCT02278874

Run by

Natera, Inc.

People needed

99

Starts

2014-08-01

Expected to finish

2019-03-01

Last updated by the study team

2019-06-13

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
• 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

You may not qualify if…

• Women carrying singleton pregnancy
• Surrogate or egg donor used

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• Long Island Jewish Medical Center — Glen Cove, New York, United States
• Mt. Sinai Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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