Genetic Testing for Fetal Abnormalities (HyDROPS Trial)

N/A

Waitlist Available

Led By Mary Norton, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up turn around time for exome sequencing results is 2-4 weeks for ongoing pregnancies and live infants, and is 8-12 weeks for stillbirths, terminations, and infant demises.

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to help researchers understand the genetic causes of non-immune hydrops fetalis and other birth defects. They will do this by sequencing the genomes of affected fetuses and neonates, and enrolling cases with known genetic explanations.

Who is the study for?

This trial is for single or twin pregnancies diagnosed with non-immune hydrops fetalis (NIHF) or other birth defects, including those with chromosomal abnormalities, postnatal samples, and stillbirths. It excludes monochorionic twins and cases where hydrops is due to red cell alloimmunization.

What is being tested?

The study investigates the genetic causes of NIHF and other congenital anomalies by performing exome sequencing on affected fetuses or neonates whose conditions are unexplained after standard evaluations.

What are the potential side effects?

Since this trial involves genetic testing through exome sequencing, there are no direct physical side effects to participants. However, there may be emotional or psychological impacts from learning about genetic results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ turn around time for exome sequencing results is 2-4 weeks for ongoing pregnancies and live infants, and is 8-12 weeks for stillbirths, terminations, and infant demises.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~turn around time for exome sequencing results is 2-4 weeks for ongoing pregnancies and live infants, and is 8-12 weeks for stillbirths, terminations, and infant demises.

This trial's timeline: 3 weeks for screening, Varies for treatment, and turn around time for exome sequencing results is 2-4 weeks for ongoing pregnancies and live infants, and is 8-12 weeks for stillbirths, terminations, and infant demises. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Genetic variants detected with exome sequencing that implicate a genetic disease underlying non-immune hydrops fetalis (NIHF) and other birth defects.

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: Exome sequencingExperimental Treatment1 Intervention

There is only one arm of this study. All enrolled participants with unexplained NIHF or other birth defect will be offered exome sequencing for the affected fetus or neonate. Please refer to the Study Design section for further details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exome sequencing

2014

N/A

~60

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