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Genetic Testing

Genome Sequencing for Congenital Heart Disease

N/A
Recruiting
Research Sponsored by Scripps Translational Science Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant individual with ongoing pregnancy with prenatally detected fetal CHD
Be older than 18 years old
Must not have
Clinical course entirely explained by known chromosomal abnormality or confirmed genetic diagnosis that explains the clinical condition
Pregnant persons under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final survey 18 months after birth
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study pregnant individuals with babies diagnosed with congenital heart disease at Rady Children's Hospital to identify genetic disorders in the unborn baby. Congenital heart disease is a common birth defect

Who is the study for?
This trial is for pregnant individuals with a prenatal diagnosis of congenital heart disease in their fetus, who want genetic testing and are planning to undergo amniocentesis or chorionic villus sampling.
What is being tested?
The study tests whole genome sequencing on fetal samples from pregnancies affected by congenital heart disease. It aims to compare the effectiveness of this method with routine clinical testing for detecting genetic disorders.
What are the potential side effects?
There are no direct side effects from the whole genome sequencing itself as it's a diagnostic procedure. However, related procedures like amniocentesis or chorionic villus sampling carry risks such as miscarriage, infection, and needle injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant and my unborn baby has been diagnosed with a heart defect.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is fully explained by a genetic diagnosis.
Select...
I am pregnant and under 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final survey 18 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and final survey 18 months after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic yield of WGS in fetal congenital heart disease
Secondary study objectives
Demographics of the cohort.
Diagnostic yield by type of CHD lesion
Patient depression and anxiety measures over time: EPDS
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Whole Genome Sequencing (WGC) from subject samplesExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Scripps Translational Science InstituteLead Sponsor
52 Previous Clinical Trials
571,538 Total Patients Enrolled
~123 spots leftby Apr 2026
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