Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies

Natera, Inc.126 enrolled

Overview

The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Vanishing Twin Trisomy 21 Trisomy 13 Trisomy 18

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin Exclusion Criteria: * Monozygotic twin pregnancy * Non twin pregnancy * Maternal history of bone marrow or organ transplantation

Locations (21)

Center for Fetal Medicine & Women's Ultrasound

Los Angeles, California, United States

Stanford

Outcomes

Primary Outcomes

Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT.

A new algorithm will be written to analyze the serial research blood samples to return a fetal fraction of each twin, and identify which twin is the DT verses the LT. The fetal fraction measurement will be a percentage, and it will be measurable, or not measurable for each sample.

Time frame: 2 years

The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.

Each complete participant in the study will have multiple maternal blood samples collected, and a child buccal swab. This outcome will use genetic analysis to reflect for each participant if the algorithm correctly or incorrectly identified the LT versus the DT. Accuracy, defined as the number of VT pairs correctly identified as the LT and DT, divided by the total number of VT pairs, will be calculated.

Time frame: 2 Years

Secondary Outcomes

The accuracy of the updated algorithm for the assignment of risk for trisomy 21/18/13 for the LT in DZ twins with a single LT.

If a sufficient number of trisomy 21/18/13 cases are observed among any of the cases, assess the accuracy of the updated algorithm to correctly determine whether the LT or DT is aneuploidy. Point estimates and 95% confidence intervals for the specificity for the aneuploidy algorithm.

Time frame: 3 Years

Data from ClinicalTrials.gov

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