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

NCT ID: NCT05004337

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-22

Study Completion Date

2023-11-29

Brief Summary

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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

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Conditions

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Vanishing Twin Trisomy 21 Trisomy 13 Trisomy 18

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Natera, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivienne Souter, MD

Role: STUDY_CHAIR

Natera, Inc.

Locations

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Center for Fetal Medicine & Women's Ultrasound

Los Angeles, California, United States

Site Status

Stanford

Palo Alto, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Yale

New Haven, Connecticut, United States

Site Status

Christiana Care

Newark, Delaware, United States

Site Status

Emerald Coast ObGyn

Panama City, Florida, United States

Site Status

University of Kansas

Kansas City, Kansas, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Beaumont

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Hackensack

Neptune City, New Jersey, United States

Site Status

St. Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status

NYU Long Island

Mineola, New York, United States

Site Status

NYU Langone

New York, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai Hospital

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Cedar Health Research

Irving, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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21-050-NPT

Identifier Type: -

Identifier Source: org_study_id

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