Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
ZTWINS
ZTWINS
Sponsor study identifier
observational
137
1 country
8
Study Start
October 1, 2021
Actual (reported)Primary Completion
May 15, 2023
Actual (reported)Study Completion
May 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)February 24, 2022
Actual (reported)April 6, 2022
Actual (reported)May 15, 2023
Actual (reported)May 15, 2023
Actual (reported)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
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.
Pregnant women carrying a twin pregnancy
Rady Children Specialists of San Diego, San Diego Perinatal Center
San Diego, California, 92123, United States
University of Colorado
Aurora, Colorado, 80045, United States
Anne Arundel Medical Center/Luminis Health
Annapolis, Maryland, 21401, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Carnegie Imaging for Women
New York, New York, 10128, United States
University of Rochester
Rochester, New York, 14642, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Ruben Quintero, MD
The Fetal Institute
137 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2022
First Posted
April 6, 2022
Study Start
October 1, 2021
Actual (reported)Sedentary Behavior Reduction in Pregnancy Intervention Study
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
Contact the study team to confirm eligibility.
Seven Hills/ Axia
Cincinnati, Ohio, 45242, United States
Primary Completion
May 15, 2023
Actual (reported)Study Completion
May 15, 2023
Actual (reported)Last Updated
September 26, 2024
Record last verified: 2024-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: