Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.

NCT ID: NCT05312814

Last Updated: 2024-09-26

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

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-05-15

Brief Summary

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The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care.

Detailed Description

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This observational data collection study will include subjects with ultrasound-confirmed twin pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial chorionicity assessment and, when available, planned twin pregnancy management (e.g., frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be recorded in the study database. Following zygosity results being returned through clinical care NIPS, updated chorionicity \& amnionicity will again be recorded in the study database. Other clinical data in the medical record as part of clinical care, including monochorionic twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and delivery and neonatal outcomes will also be recorded in the study database. There will be no study blood sample collection or other study procedures performed as part of this study.

Conditions

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Twin to Twin Transfusion Syndrome Pregnancy Complications Multiple Gestation; Maternal Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Twin pregnancies undergoing non-invasive prenatal screening

Women carrying a twin pregnancy undergoing non-invasive prenatal screening for zygosity and aneuploidy syndromes.

No drug/device will be administered; clinical data will be collected for research analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria

* Singleton or non-twin multiple pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Ruben Quintero, MD

Role: PRINCIPAL_INVESTIGATOR

The Fetal Institute

Locations

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Rady Children Specialists of San Diego, San Diego Perinatal Center

San Diego, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Anne Arundel Medical Center/Luminis Health

Annapolis, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Carnegie Imaging for Women

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Seven Hills/ Axia

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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21-051-NPT

Identifier Type: -

Identifier Source: org_study_id

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