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

Completed

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

• Registration Number: NCT05312814
• Lead Sponsor: Natera, Inc.

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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-06
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

Inclusion Criteria

• Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria

• Singleton or non-twin multiple pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (8)

Rady Children Specialists of San Diego, San Diego Perinatal Center; 🇺🇸 San Diego, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Anne Arundel Medical Center/Luminis Health; 🇺🇸 Annapolis, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Carnegie Imaging for Women; 🇺🇸 New York, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

UNC Chapel Hill; 🇺🇸 Chapel HIll, North Carolina, United States

Seven Hills/ Axia; 🇺🇸 Cincinatti, Ohio, United States