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

Natera, Inc.137 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

137

Conditions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with an ultrasound confirmation of twin pregnancy Exclusion Criteria: * Singleton or non-twin multiple pregnancy

Locations (8)

Rady Children Specialists of San Diego, San Diego Perinatal Center

San Diego, California, United States

University of Colorado

Aurora, Colorado, United States

Anne Arundel Medical Center/Luminis Health

Annapolis, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Assess clinical utility of combining NIPT-based zygosity measurements with ultrasound chorionicity assessments for the management of twin pregnancies.

Primary outcome will be measured by determining the overall frequency of NIPT-determined monozygosity among twin pregnancies; the frequency of discordance between NIPT-determined zygosity and ultrasound only chorionicity assessments; and the proportion of twin pregnancies with twin--twin transfusion syndrome (TTTS) that are diagnosed late as compared with historical rates.

Time frame: 2 years

Frequency of monozygosity

Measuring overall frequency of NIPT-determined monozygosity among twin pregnancies, measured by the number monozygotic pregnancies over the total number of twin pregnancies in the study.

Time frame: 2 years

Frequency of changed chorionicity assessment

The frequency of discordance between NIPT-determined zygosity and ultrasound only chorionicity assessments, as measured by the total number of pregnancies with a change in chorinicity assessment following the NIPT-based zygsity results release.

Time frame: 2 years

Frequency of late TTTS diagnosis

The frequency of late diagnosis of Twin to Twin Transfusion Syndrome (TTTS) in twin pregnancies with TTTS will be compared with historical rates of late TTTS diagnosis.

Time frame: 2 years

Data from ClinicalTrials.gov

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