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.