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

Completed

• Conditions: Vanishing Twin; Trisomy 13; Trisomy 18; Trisomy 21

• Registration Number: NCT05004337
• Lead Sponsor: Natera, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-22
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-13
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.	2 Years	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.
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.	2 years	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.

Secondary Outcome Measures

Name	Time	Method
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.	3 Years	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.

Trial Locations

Locations (21)

Center for Fetal Medicine & Women's Ultrasound; 🇺🇸 Los Angeles, California, United States

Stanford; 🇺🇸 Palo Alto, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Yale; 🇺🇸 New Haven, Connecticut, United States

Christiana Care; 🇺🇸 Newark, Delaware, United States

Emerald Coast ObGyn; 🇺🇸 Panama City, Florida, United States

University of Kansas; 🇺🇸 Kansas City, Kansas, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Beaumont; 🇺🇸 Royal Oak, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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