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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Twin to Twin Transfusion Syndrome Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetofetal Transfusion Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases Multiple Gestation; Maternal Care Pregnancy Complications Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Rady Children Specialists of San Diego, San Diego Perinatal Center, San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with an ultrasound confirmation of twin pregnancy

Exclusion criteria

Singleton or non-twin multiple pregnancy

Treatment and study plan

Primary outcomes

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

Time frame: 2 years

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.
Frequency of monozygosity

Time frame: 2 years

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.
Frequency of changed chorionicity assessment

Time frame: 2 years

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.
Frequency of late TTTS diagnosis

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Acronym: ZTWINS

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 6, 2022
Registry last updated: Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting