MedTrace Logo

Prenatal Genetic Diagnosis by Genomic Sequencing

NCT03936101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1097

Last updated 2025-10-27

Study results available
· View outcomes & findings →

Summary

This study is evaluating the impact of prenatal sequencing on the management of fetuses with ultrasound abnormalities. The hypothesis is that a significant subset of fetal abnormalities have a genetic cause that can be identified by sequencing and that prenatal knowledge of this information will improve prenatal care, reduce unnecessary diagnostic testing, reduce the cost of care, and improve the quality of life for both the child and the family.

Conditions

  • Fetal Structural Anomalies

Interventions

DIAGNOSTIC_TEST

Prenatal Genomic Sequencing

Whole genome sequencing (which initially will be masked and reported as exome only)

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Baylor College of Medicine

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • The George Washington University Biostatistics Center

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Broad Institute of MIT and Harvard

    collaborator OTHER

  • The Jackson Laboratory

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Ronald Wapner, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2024-03-25
Completion
2024-03-25

Countries

  • United States

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 NCT03936101 on ClinicalTrials.gov