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

Pregnancy Complications Clinical Trial

— ZTWINS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312814
• Other study ID #: 21-051-NPT
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: November 2023
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria:

• Singleton or non-twin multiple pregnancy

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Pregnancy Complications
• Twin to Twin Transfusion Syndrome

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center/Luminis Health	Annapolis	Maryland
United States	University of Colorado	Aurora	Colorado
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Seven Hills/ Axia	Cincinnati	Ohio
United States	Carnegie Imaging for Women	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Rady Children's Specialists of San Diego, San Diego Perinatal Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years