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

NCT05312814 | Completed

• 1 other identifier: 21-051-NPT
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a twin pregnancy

You may qualify if:

• Women with an ultrasound confirmation of twin pregnancy

You may not qualify if:

• Singleton or non-twin multiple pregnancy

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (8)

Rady Children Specialists of San Diego, San Diego Perinatal Center

San Diego, California, 92123, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Anne Arundel Medical Center/Luminis Health

Annapolis, Maryland, 21401, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Carnegie Imaging for Women

New York, New York, 10128, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Seven Hills/ Axia

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Fetofetal Transfusion; Pregnancy Complications

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ruben Quintero, MD

  The Fetal Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 6, 2022
• Study Start: October 1, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (8)