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

Natera

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05312814

21-051-NPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with an ultrasound confirmation of twin pregnancy

Exclusion criteria

• Singleton or non-twin multiple pregnancy

Trial design

137 participants in 1 patient group

Twin pregnancies undergoing non-invasive prenatal screening

Description:

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.