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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Twin to Twin Transfusion Syndrome; Multiple Gestation; Maternal Care

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: ZTWINS Team; Phone Number: (650) 249-9090; Email: ztwins@natera.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Specialists of San Diego, San Diego Perinatal Center
      • Contact: Deirdre McCullough, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: K.Joseph Hurt, MD, PhD
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
      • Anne Arundel Medical Center/Luminis Health
      • Contact: Clark Johnson, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Myra Wick, MD, PhD
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • Carnegie Imaging for Women
      • Contact: Andrei Rebarber, MD
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Neil Seligman, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • UNC Chapel Hill
      • Contact: Neeta Vora, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Seven Hills/ Axia
      • Contact: Gerard Reilly, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a twin pregnancy

Description

Inclusion Criteria:

• Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria:

• Singleton or non-twin multiple pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Natera, Inc.
• Investigators: Principal Investigator: Ruben Quintero, MD, The Fetal Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Pregnancy Complications; Fetofetal Transfusion
• Other Study ID Numbers: 21-051-NPT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No