Pilot study: Diagnosis of congenital heart disease with fetal ECG
Recruiting
- Conditions
- Congenital heart defects
- Registration Number
- NL-OMON20695
- Lead Sponsor
- Máxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
In order to be eligible to participate in the cross-sectional study, a subject must meet all of the following criteria:
-Pregnant women carrying a healthy fetus
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Multiple Pregnancies
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: To establish the normal ranges or values of amplitudes, segment intervals (with 95% confidence intervals) and the heart axis of the fECG in a healthy fetus. <br><br><br>
- Secondary Outcome Measures
Name Time Method Secondary Objective: To compare the fECG between healthy fetuses and fetuses with various forms of severe CHD. To determine the diagnostic value of fECG to detect CHD.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie fetal ECG detection of congenital heart defects in early gestation?
How does non-invasive fetal ECG compare to fetal echocardiography in diagnosing specific congenital heart disease subtypes?
Which biomarkers correlate with fetal ECG signal quality for accurate congenital heart defect diagnosis?
What adverse events are associated with non-invasive fetal ECG monitoring in high-risk pregnancies?
What alternative non-invasive diagnostic methods for congenital heart disease are being evaluated alongside fetal ECG at Máxima Medisch Centrum?