NL-OMON44934
Completed
Not Applicable
Pilot study: Evaluation of the non-invasive fetal electrocardiogram, regarding the diagnosis of congenital heart diseases. - Pilot study: Diagnosing congenital heart diseases with fetal ECG.
Maxima Medisch Centrum0 sites360 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Maxima Medisch Centrum
- Enrollment
- 360
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cross\-sectional study: pregnant women, carrying a healthy, singleton fetus with a gestational age between 18 and 24 weeks. Participants must be aged older than 18 years. Case\-cohort study: pregnant women, carrying a singleton fetus with a known severe congenital heart disease or cardiac arrhythmia, with a gestational age between 18 and 30 weeks. Participants must be aged older than 18 years. Severe CHD will be defined as a form of CHD with hemodynamic importance and/or an operation or intervention in the first year of life.
Exclusion Criteria
- •Women under the age of 18 years old, multiple pregnancies, women carrying a fetus with a known congenital abnormality other than congential heart disease.
Outcomes
Primary Outcomes
Not specified
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