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ACTIVE NOT RECRUITING
NCT03831256
NA

PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

Summary

This project aims to provide high- quality evidence to inform decisions by health care organisations about using first-tier non-invasive prenatal screening (NIPS) to replace traditional screening tests for trisomy 21, and potentially to screen for other fetal chromosome anomalies. We will compare the current screening approach of second-tier NIPS with the use of first-tier NIPS in a large cohort of pregnant women.

Official title: PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood : Towards First Tier Screening and Beyond

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7849

Start Date

2020-01-13

Completion Date

2025-06-30

Last Updated

2025-02-12

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Traditional integrated prenatal screening

biochemical prenatal screening with or without nuchal translucency by US

DIAGNOSTIC_TEST

Second-tier Non-invasive prenatal screening (NIPS)

genomics based NIPS after a positive traditional prenatal screen

DIAGNOSTIC_TEST

First-tier Non-invasive prenatal screening (NIPS)

genomics based NIPS at first trimester

DIAGNOSTIC_TEST

Invasive prenatal testing for fetal aneuploidy

amniocentesis or chorionic villi sampling (CVS)

Locations (6)

Kelowna Regional Fertility Center

Kelowna, British Columbia, Canada

Prince Rupert Regional Hospital

Prince Rupert, British Columbia, Canada

Children's & Women's Health Centre

Vancouver, British Columbia, Canada

CHU Ste-Justine

Montreal, Quebec, Canada

CHU de Québec - Université Laval

Québec, Quebec, Canada

CIUSSS Côte-Nord

Sept-Îles, Quebec, Canada