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Genetic Testing
Genetic Testing for Fetal Abnormalities (HyDROPS Trial)
N/A
Waitlist Available
Led By Teresa Sparks, 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
HyDROPS Trial 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.Check my eligibility
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.See study design
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.
HyDROPS Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Genetic variants detected with exome sequencing that implicate a genetic disease underlying non-immune hydrops fetalis (NIHF) and other birth defects.
HyDROPS 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.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,039 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,150 Total Patients Enrolled
1 Trials studying Hydrops Fetalis
500 Patients Enrolled for Hydrops Fetalis
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,055 Total Patients Enrolled
2 Trials studying Hydrops Fetalis
510 Patients Enrolled for Hydrops Fetalis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pregnancy involves NIHF or another birth defect, including cases with chromosomal abnormalities or stillbirths.
Research Study Groups:
This trial has the following groups:- Group 1: Exome sequencing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could individuals younger than 85 years old be considered for this medical research?
"According to the selection criteria, individuals aged 18-55 are eligible for this trial. There are 58 trials that accept subjects younger than 18 and 164 studies open for people over 65 years old."
Answered by AI
Who is eligible to be enrolled in this medical experiment?
"This clinical trial seeks 500 people aged between 18 and 55 who have been diagnosed with hydrops fetalis prenatally. Eligibility criteria includes singletons or dichorionic twin pregnancies, cases of chromosomal abnormalities, postnatal samples, and stillbirths."
Answered by AI
Is this experiment open to participants at present?
"This medical study, which dates back to October 11th 2018 and was last modified on September 27th 2021, is not actively enrolling patients. Although this trial does not require participants at present, 210 other studies are currently recruiting for volunteers."
Answered by AI
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