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New treatment option for Heart Defects, Congenital
Official title HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
ClinicalTrials.gov ID: NCT06175104
What this study is testing
- What it's testing
- Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
- Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
- Singleton pregnancy.
- Pregnant person is planning to continue with the pregnancy.
- Pregnant person is able to participate and complete study assessments in English.
You likely can't join if
- Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
- Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
- Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or...
- Parent with a moderate to severe intellectual disability.
- Parent age \<18 years.
- Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Cincinnati, Ohio, United States
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Cincinnati, Ohio, United States; Randwick, New South Wales, Australia; Westmead, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.