The primary research objective is to assess the feasibility of fetal CMR in all academic centers in The Netherlands.The second research objective of the study is to investigate the diagnostic capacity of fetal CMR for aortic and pulmonary CHD and…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To test feasibility of fetal CMR on the three available MRI vendors (Philips,
Siemens, General Electric) in all academic centers in The Netherlands.
Secondary outcome
To assess diagnostic capacity of fetal CMR and the additive value to fetal
echocardiography (at gestational age 20-24 weeks and 30-34 weeks) for correct
antenatal diagnosis of significant aortic and/or pulmonary CHD (correct CHD
diagnosis based on postnatal findings).
Background summary
Congenital heart disease (CHD) is the most common of all major congenital
anomalies and affects around 9 out of 1000 live births. Mortality rates have
been reduced, but CHD is still the second most frequent cause of neonatal
death2. Fetal echocardiography has significantly improved antenatal diagnosis
of CHD, but limitations remain. Discordance between pre- and postnatal
diagnosis of CHD has been described, with impact on neonatal management.
Especially vascular anomalies such as coarctation of the aorta, have proven to
be difficult to detect and predict by fetal echocardiography. Therefore, there
is a clinical need for a complementary imaging modality to further improve the
current fetal diagnostic work-up of CHD, for which recently developed fetal
cardiovascular magnetic resonance imaging (CMR) may be suited.
Hypothesis: Fetal CMR may improve the diagnostic accuracy of prenatal diagnosis
of CHD when compared to fetal echocardiography in The Netherlands.
Study objective
The primary research objective is to assess the feasibility of fetal CMR in all
academic centers in The Netherlands.
The second research objective of the study is to investigate the diagnostic
capacity of fetal CMR for aortic and pulmonary CHD and the additive value to
fetal echocardiography (at gestational age 20-24 weeks and 30-34 weeks) for
correct antenatal diagnosis of CHD.
Study design
Prospective cohort study of expectant mothers of fetuses with significant
aortic and/or pulmonary CHD undergoing fetal CMR and fetal echocardiographic
evaluation.
Study burden and risks
The burden for both the mother and the fetus is the experience of undergoing
fetal CMR,. Fetal CMR can be performed within 30/45 minutes of scan time, which
can be difficult for a mother in her third trimester of pregnancy. Therefore,
specific attention will be paid to the mother*s condition, as she will be
positioned in a comfortable position and with left lateral tilt, to prevent
vena cava inferior syndrome, and hearing protection will be offered. Fetal MRI
for other purposes such as fetal brain imaging is performed in most
participating institutions, which facilitates the introduction of fetal CMR.
Current experimental and clinical evidence indicates that there are no adverse
biological effects for pregnant women, fetuses and neonates from the use of
CMR14,15. MRI vendor differences between the participating institutions
(Philips, Siemens and General Electric) will be overcome by support of our two
study MRI physicists and by an international scientific advisory committee with
ample experience in fetal CMR. The post-processing techniques are considered to
be generic and applicable/compatible to all available MRI systems in the
participating centers.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Inclusion criteria
Antenatal diagnosis of significant aortic and/or pulmonary CHD, defined as
requiring intervention within the first year of postnatal life.
Informed consent provided by both parents.
Gestational age >24 weeks. The optimal gestational age for fetal CMR currently
lies between 30-34 weeks.
Exclusion criteria
Maternal age <16 years
Inability to correctly inform parents about study due to language barrier or
other factors
Contraindication to MRI (see Radiology department checklist)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL86052.041.24 |