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Virtual counseling may help mothers facing a fetal heart defect

NCT ID NCT05129631

Symptom relief Sponsor: Nemours Children's Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests HEARTPrep, a virtual counseling program designed to support mothers who are expecting a baby with congenital heart disease. The program aims to reduce depression, anxiety, and social isolation during pregnancy. Researchers will enroll 30 mothers and their partners, measuring emotional well-being over six weeks. The goal is to see if this approach can improve maternal mental health and potentially benefit the child's development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HEARTPrep, a virtually-delivered psychosocial intervention
What this could lead to
If it works, HEARTPrep could offer a practical way to support mothers during a stressful pregnancy, potentially improving their emotional health and the baby's development.
What could go wrong
This is a small pilot study with 30 participants, so results may not apply to all mothers. The program's success depends on how well it reduces stress, which is hard to measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Jul 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life * Partners of participating expectant mothers can also participate together with the mother * Receiving fetal cardiac care at Nemours Children's Health * Speaks English or Spanish fluently * Age 18 or older * Access to a computer, tablet or mobile device with internet access Exclusion Criteria: -Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease

Contacts and locations

Locations

  • Nemours Children's Health

    Wilmington, Delaware, 19803, United States

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