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PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood

NCT03831256 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7849

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

  • Prenatal Disorder
  • Aneuploidy

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)

Sponsors & Collaborators

  • Genome Quebec

    collaborator OTHER

  • Genome British Columbia

    collaborator INDUSTRY

  • Genome Alberta

    collaborator OTHER

  • Ontario Research Fund

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • St. Justine's Hospital

    collaborator OTHER

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Genome Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Sylvie Langlois, MD FRCPC · University of British Columbia

  • Francois Rousseau, MD MSc FRCPC · CHU de Québec - Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2023-12-31
Completion
2025-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831256 on ClinicalTrials.gov