Cross-sectional study: To detect the normal range of amplitudes and segment intervals of the fECG. Case-cohort study: To compare the fECG between healthy fetuses and fetuses with various forms of severe CHD. To determine the diagnostic value of fECG…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Congenital heart disease (CHD) is a severe condition, which needs early
detection and treatment. The current method for detecting CHD during pregnancy
is a structural ultrasound at week 20 of gestational age. Only 25 to 60 per
cent of the cases are detected by this method. Therefore, there is need for a
technique with a higher specificity, in order to guarantee early detection.
This new technique could be the transabdominal non-invasive fetal
electrocardiogram (fECG). In order to detect the different abnormalities, the
normal ranges of amplitudes, segment intervals and the heart axis (with 95%
confidence intervals (CI)) of the fECG have to be established.
Study objective
Cross-sectional study: To detect the normal range of amplitudes and segment
intervals of the fECG.
Case-cohort study: 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.
Study design
This study will be performed as a cross-sectional and a case-cohort study. The
first part of the research (cross-sectional study) will be performed in the
Máxima Medical Center in Veldhoven (MMC) and Diagnostic Centre Eindhoven (DVU).
This study focuses on the normal range of amplitudes, segment intervals and
heart axis (all with 95% CI) of the fECG. The second part (case-cohort study)
will focus on the values of the amplitudes, segment intervals, heart axis (with
95% CI) and ventricle volumetry measurements of fetuses with diagnosed form of
severe CHD like Fallot*s tetralogy. CHD is detected by the current screening
method, the structural ultrasound. The center at which the CHD is diagnosed,
informs the patient about our study and contacts us if the patient is willing
to participate in the study. The participating centers are asked to make a 3D
echocardiography of the foetus. Centers involved in this research are the
tertiary care hospitals: MMC Veldhoven, Radboud Medical Center Nijmegen (UMCN),
Academic Medical Center (AMC) Amsterdam en Leiden University Medical Center
(LUMC).
Study burden and risks
There are no physical risks or side effects of the fECG measurement or the
ultrasound to the mother, fetus or third parties. Allergy or irritation from
the used electrodes or the conduction gel are the only conceivable problems.
This is rare. All of the used equipment is approved by the Medical Technical
Service Department of the Máxima Medical Centrum in safety tests.The conduction
gel is widely used for ultrasonography and is safe to use. In pregnant women,
one must always bear in mind the risk of aortocaval compression. From
midpregnancy onwards, the enlarged uterus compresses both the inferior vena
cava and the lower aorta when the patient is lying in supine position. To
prevent this from happening, the patient will be placed in a semi-recumbent
position or left lateral tilt position during the measurements.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL48535.015.14 |
| OMON | NL-OMON20695 |