RecruitingNot ApplicableNCT06211348

Genomic Sequencing in Anatomically Normal Fetuses


Sponsor

University of California, San Francisco

Enrollment

1,000 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This cohort study will examine the clinical utility of genomic sequencing (GS) in patients undergoing prenatal diagnostic procedures (chorionic villus sampling or amniocentesis) for routine indications other than a structural fetal anomaly.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria4

  • Pregnant patients who are:
  • Pregnant with a structurally normal fetus (singleton or multiple gestation)
  • Planning to undergo prenatal diagnosis by either chorionic villus sampling or amniocentesis with chromosome microarray analysis for routine indications
  • Planning, or have already completed expanded carrier screening

Exclusion Criteria4

  • Pregnant patients who:
  • Decline prenatal diagnostic testing
  • Are pregnant and their fetus has a known anomaly
  • Declined chromosomal microarray analysis of expanded carrier screening

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Interventions

DEVICEGenomic Sequencing

Individuals who request prenatal diagnostic testing with standard chromosomal microarray will be offered genomic sequencing (GS) as an option to assess for additional disease risk.


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06211348