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Moms' stress in pregnancy linked to baby brain outcomes in heart defect study

NCT ID NCT06711666

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study looks at 174 mothers whose babies were diagnosed with serious heart defects before birth. Researchers will track the mothers' mental health from the third trimester until the baby is one year old, and then test the babies' brain development. The goal is to understand if a mother's stress, anxiety, or depression during pregnancy affects how her child's brain grows after heart surgery.

What this could mean

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

What this could lead to
If successful, this could help identify ways to support mothers' mental health during pregnancy to improve brain development in children with heart defects.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any intervention, so results may only suggest associations, not causes.

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.

Participants

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.

Ages

Up to 50 years

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 for the mother of a child diagnosed with CHD: 1. Age at least 18 years old 2. Expecting women 3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1). 4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study. 5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux). 6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease. 7. Social security affiliation in France. Inclusion criteria for the father or co-parent: 1. Co-parent of an expecting woman participating in the study 2. Age at least 18 years old 3. Social security affiliation in France. Inclusion criteria for the child diagnosed with congenital heart disease: 1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study 2. Written consent from both parents 3. Social security affiliation in France. Non-inclusion Criteria for mothers: 1. Patient refusal to participate 2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy 3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes). 4. Participants who are not able to understand the instructions and/or complete the self-reports 5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation. 6. Persons under legal or judicial guardianship. Non-inclusion Criteria for fathers or co-parents: 1. Patient refusal to participate 2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment 3. Persons under legal or judicial guardianship. Exclusion Criteria for the mother of a child diagnosed with CHD: 1\. The child has not undergone surgery within 60 days of birth. Exclusion Criteria for children with CHD: 1\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Montpellier

    RECRUITING

    Montpellier, France

  • Hopital Haut Leveque

    RECRUITING

    Pessac, France

  • Hopital Necker Enfants Malades

    RECRUITING

    Paris, France

  • Hopital de Marseille la Timone

    RECRUITING

    Marseille, France

  • Institut Saint Pierre

    RECRUITING

    Palavas-les-Flots, France

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