CompletedNot Applicable

High Risk Multiple Gestation Study

United States99 participantsStarted 2014-08

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Women carrying singleton pregnancy * Surrogate or egg donor used

What they're measuring

Screening capability of proprietary algorithm in the form of a risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'

Timeframe: 4 years

Trial details

NCT IDNCT02278874

SponsorNatera, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-12-01