Clinical trial NCT05312814: Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
Official title: Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Twin to Twin Transfusion Syndrome
Pregnancy Complications
Multiple Gestation; Maternal Care
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women carrying a twin pregnancy

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.

Eligibility criteria: Inclusion Criteria:

* Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria:

* Singleton or non-twin multiple pregnancy

Primary outcomes:
measure: Assess clinical utility of combining NIPT-based zygosity measurements with ultrasound chorionicity assessments for the management of twin pregnancies.
timeFrame: 2 years
measure: Frequency of monozygosity
timeFrame: 2 years
measure: Frequency of changed chorionicity assessment
timeFrame: 2 years
measure: Frequency of late TTTS diagnosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children Specialists of San Diego, San Diego Perinatal Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Annapolis
country: United States
facility: Anne Arundel Medical Center/Luminis Health
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Carnegie Imaging for Women
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel HIll
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Cincinatti
country: United States
facility: Seven Hills/ Axia
state: Ohio
Study officials:
affiliation: The Fetal Institute
name: Ruben Quintero, MD
role: PRINCIPAL_INVESTIGATOR
References: