Clincosm LogoSign in Get a demo

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

Sponsor
Natera, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05312814
Collaborator
(none)
700
Enrollment
8
Locations
25
Anticipated Duration (Months)
87.5
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

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

    2. Frequency of monozygosity [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.

    3. Frequency of changed chorionicity assessment [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.

    4. Frequency of late TTTS diagnosis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women with an ultrasound confirmation of twin pregnancy
    Exclusion Criteria:
    • Singleton or non-twin multiple pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rady Children's Specialists of San Diego, San Diego Perinatal Center San Diego California United States 92123
    2 University of Colorado Aurora Colorado United States 80045
    3 Anne Arundel Medical Center/Luminis Health Annapolis Maryland United States 21401
    4 Mayo Clinic Rochester Minnesota United States 55905
    5 Carnegie Imaging for Women New York New York United States 10128
    6 University of Rochester Rochester New York United States 14642
    7 UNC Chapel Hill Chapel Hill North Carolina United States 27516
    8 Seven Hills/ Axia Cincinnati Ohio United States 45242

    Sponsors and Collaborators

    • Natera, Inc.

    Investigators

    • Principal Investigator: Ruben Quintero, MD, The Fetal Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Natera, Inc.
    ClinicalTrials.gov Identifier:
    NCT05312814
    Other Study ID Numbers:
    • 21-051-NPT
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pregnancy Complications
    Fetofetal Transfusion

    Study Results

    No Results Posted as of Apr 12, 2022