Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For the mother:
- Women who are at least 18 years old
- Women who are currently pregnant
- Women whose unborn baby has been diagnosed with a serious type of congenital heart disease (a heart condition present before birth that can affect how well the baby's blood carries oxygen after delivery)
- Women who are between 28 and 38 weeks pregnant at the time of joining the study
- Women who are receiving medical care at one of the three participating hospitals (Montpellier, Necker Children's Hospital in Paris, or Bordeaux)
- Women for whom at least 4 weeks have passed since their baby's heart condition was first diagnosed
- Women who are affiliated with the French social security system
For the father or co-parent:
- The co-parent of a pregnant woman already participating in the study
- At least 18 years old
- Affiliated with the French social security system
For the child:
- A child born to a mother already in the study, whose heart condition was diagnosed before birth and is not linked to any other known condition
- Both parents must have given written consent
- The child must be affiliated with the French social security system
Who may not be able to join:
For the mother:
- Women who do not wish to participate
- Women who are considering ending the pregnancy
- Women whose baby's heart condition is associated with another condition known to affect brain development, such as certain genetic syndromes (for example, trisomies or multiple abnormalities)
- Women who are not able to understand the study instructions or complete the required questionnaires
- Women who currently have a significant psychiatric condition, such as untreated major depression, severe anxiety, or psychotic disorders — women in this situation would be referred to a specialist for support
- Women who are under legal guardianship
For the father or co-parent:
- Those who do not wish to participate
- Those who have a severe psychiatric condition, such as severe depression or psychotic disorders, whether or not they are receiving treatment
- Those who are under legal guardianship
After joining — reasons a participant may be removed from the study:
For the mother:
- If the child does not have heart surgery within 60 days of birth
For the child:
- If a genetic condition or brain abnormality is identified that would make assessing the child's development difficult
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 330603830737
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80); Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.