Congenital heart diseases
Conditions
Interventions
None listed
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recordings are performed between 08.00 h and 16.00 h during appointments at the outpatient clinic and will take no longer than 45 minutes. The fECG is a non-invasive, transabdominal approach with self-adhesive electrodes placed in a fixed configuration. A non-invasvie, electrophysiologic monitor is used to record and store the electrical activity on the maternal abdomen. During the fECG measurement an ultrasound is made four times for a short period, to determine the position of the fetus in utero. The collected data will be analysed off-line. The maternal ECG is removed, without effecting the present fECG-complexes. The amplitudes (P-, QRS- and T-top), segment intervals and heart axis will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed