Clinical Trial: High Risk Multiple Gestation Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood

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 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 CVS procedures, which are associated with a risk of miscarriage.


Detailed Summary:
Sponsor: Natera, Inc.

Current Primary Outcome: Screening capability of NATUS algorithm in the form of a risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.' [ Time Frame: 2 years ]

The primary outcome will be to confirm the diagnostic capability of NATUS risk results (a risk score eg 1:100) classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.' The outcome will be determined as a risk score given for samples collected. This outcome will be compared to the diagnostic testing results of ploidy status.

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. This will be used to determine the true ploidy status of the fetuses.



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Natera, Inc.

Dates:
Date Received: August 27, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017