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Genetic Testing

Whole Genome Sequencing (WGC) from subject samples 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final survey 18 months after birth

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am pregnant and my unborn baby has been diagnosed with a heart defect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final survey 18 months after birth

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic yield of WGS in fetal congenital heart disease

Secondary outcome measures

Demographics of the cohort.

Diagnostic yield by type of CHD lesion

Patient depression and anxiety measures over time: EPDS

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Whole Genome Sequencing (WGC) from subject samplesExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scripps Translational Science InstituteLead Sponsor

51 Previous Clinical Trials

579,361 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals participating in this clinical investigation?

"Affirmative. As per clinicaltrials.gov, this investigation is presently seeking participants. Initially shared on January 9th, 2024, the latest update was provided on February 9th of the same year. The aim is to enroll 200 participants at a single site."

Answered by AI

Is the enrollment for this research study currently open and accepting participants?

"At present, clinicaltrials.gov indicates that patient recruitment is ongoing for this particular trial. The trial was first listed on 1/9/2024 and last modified on 2/9/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Sequencing for Detection in Congenital Heart Disease (SD-CHD) Study

Rebecca Reimers 2024. "The Sequencing for Detection in Congenital Heart Disease (SD-CHD) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06244940.

All > Paid Studies San Diego > Heart Disease