BridgeMD
New treatment option for Congenital Heart Disease
Official title Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS
ClinicalTrials.gov ID: NCT06705543
What this study is testing
What is multi-omics genetic analyses included exome?
multi-omics genetic analyses included exome is an investigational medicine, being studied as a potential treatment for congenital heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will use multiOMICS study on fetuses with complexe congenital heart defects (CHD) to identify etiological epigenetic factors of these cardiac malformations, related to environmental factors during pregnancy.
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, women only. Healthy volunteers may be eligible.
You may be able to join if
- Fetuses with congenital heart disease :
- Pregnant women aged 18 and more
- Single foetal pregnancy in which the foetus has a complex non-syndromic congenital heart defect, with no identified chromosomal abnormality, gene...
- Patient for whom the indication for amniocentesis has been accepted by the CPDPN and accepted by the couple/patient
- Gestational age between 20 and 28 weeks' gestation.
You likely can't join if
- For both populations (cases and controls) :
- Female minors,
- Patients not affiliated to the social security system,
- Patients who do not understand French,
- Patients under guardianship
- Multiple pregnancies, or where the foetus has associated malformations
See the full eligibility criteria
- Fetuses with congenital heart disease :
- Pregnant women aged 18 and more
- Single foetal pregnancy in which the foetus has a complex non-syndromic congenital heart defect, with no identified chromosomal abnormality, gene syndrome or infection.
- Patient for whom the indication for amniocentesis has been accepted by the CPDPN and accepted by the couple/patient
- Gestational age between 20 and 28 weeks' gestation.
- Person affiliated to or benefiting from a social security scheme.
- Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research). Control Population for RNAseq and MéthlySeq
- Pregnant women aged 18 and more
- Patient in whom the indication for amniocentesis has been retained by the CPDPN and accepted by the couple/patient, for a non-malformative ultrasound anomaly (hyperechoic bowel, idiopathic hydramnios, increased risk of...
- Gestational age between 20 and 28 weeks' gestation.
- Person affiliated to or benefiting from a social security scheme.
- Free, informed and express consent (confirmed in writing) (at the latest on the day of inclusion and before any examination required by the research).
- For both populations (cases and controls) :
- Female minors,
- Patients not affiliated to the social security system,
- Patients who do not understand French,
- Patients under guardianship
- Multiple pregnancies, or where the foetus has associated malformations
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Nantes, France
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 female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Nantes, France. 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.