Pilot study: Evaluation of the non-invasive fetal electrocardiogram, regarding the diagnosis of congenital heart diseases.
Completed
- Conditions
- Congenital heart diseases1001039410028920
- Registration Number
- NL-OMON44934
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The recordings are performed between 08.00 h and 16.00 h during appointments at<br /><br>the outpatient clinic and will take no longer than 45 minutes. The fECG is a<br /><br>non-invasive, transabdominal approach with self-adhesive electrodes placed in a<br /><br>fixed configuration. A non-invasvie, electrophysiologic monitor is used to<br /><br>record and store the electrical activity on the maternal abdomen. During the<br /><br>fECG measurement an ultrasound is made four times for a short period, to<br /><br>determine the position of the fetus in utero. The collected data will be<br /><br>analysed off-line. The maternal ECG is removed, without effecting the present<br /><br>fECG-complexes. The amplitudes (P-, QRS- and T-top), segment intervals and<br /><br>heart axis will be calculated. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To compare the fECG between healthy fetuses and fetuses with various forms of<br /><br>severe CHD. To determine the diagnostic value of fECG to detect CHD.</p><br>