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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Multiple gestation high risk pregnancies women pregnant with twins or triplets at high risk for aneuploidy

More Details

Status
Completed
Sponsor
Natera, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.