Comparison of prenatal and postnatal cardiac function assessed by echocardiography using 2-D, 3-D, pulsed wave Doppler, Tissue Doppler and (blood) speckle tracking (focussing on strain and strain rate) between fetuses/neonates with structural heart…
ID
Source
Brief title
Condition
- Heart failures
- Cardiac and vascular disorders congenital
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of fetal systolic and diastolic function in fetuses with a
structural heart disease, fetuses with an FGR and healthy fetuses, using
(blood) speckle tracking, pulsed waved Doppler and tissue Doppler, at multiple
time points in the pregnancy and within 72 hours postpartum.
Secondary outcome
Technical feasibility of cardiac function measurements by means of fetal
echocardiography using speckle tracking, pulsed waved Doppler and tissue
Doppler in fetuses with a structural heart disease. This includes the
comparison of two software*s used to evaluate cardiac deformation (TOMTEC and
Voluson Fetal HQ) by speckle tracking and the additional value of fetal
electrocardiogram during cardiac function measurements and the optimization of
the used techniques.
Background summary
Currently, fetal echocardiography mainly focusses on the detection of
structural heart disease. New echocardiographic techniques also permit detailed
assessment of the myocardial contraction and relaxation, permitting early
detection of subtle changes in heart function. Structural heart disease and
fetal growth restriction are often accompanied by changes in myocardial
function. These changes already start during early intrauterine life. They can
influence clinical course and outcome during fetal adaptation to hypoxic
intrauterine conditions, during transition from fetal to neonatal circulation
and during early neonatal life in both growth restricted infants and infants
with heart disease. With improved survival of these infants, it becomes clear
that these changes in cardiac function, subtle in early life, often progress or
induce remodelling affecting long term cardiovascular outcome. Expanding the
ultrasonic examination of the heart by adding measurements related to fetal
cardiac function would increase knowledge about the physiology and
pathophysiology of cardiac adaptation during fetal and early neonatal life in
healthy infants as well in infants with fetal growth restriction and/or a
structural heart disease.
Early detection of dysfunction could lead to targeted preventive strategies to
improve short term and long term cardiovascular outcomes in these vulnerable
children.
Early changes before overt cardiac dysfunction can be observed by analysing
myocardial deformation during contraction and relaxation with ultrasonic
techniques such as (blood) speckle-tracking (focussing on myocardial strain and
strain rate) and Tissue Doppler. These techniques are validated in the adult
and pediatric populations but remain experimental in fetuses. The fetal heart
is much smaller, beats faster and is more difficult to assess through the
maternal abdomen. Besides that, the circulation and balance between left and
right ventricle is fundamentally different in a fetus. This brings challenges
in technical feasibility as well as in clinical interpretation of differences.
Recent technical innovations permit to overcome the former and gain experience
with the latter.
Along with 2-D, 3-D and pulsed waved Doppler assessments, inclusion of these
techniques could be of additional value in the assessment of the fetal heart.
Study objective
Comparison of prenatal and postnatal cardiac function assessed by
echocardiography using 2-D, 3-D, pulsed wave Doppler, Tissue Doppler and
(blood) speckle tracking (focussing on strain and strain rate) between
fetuses/neonates with structural heart disease, fetuses/neonates with fetal
growth restriction (FGR) and healthy fetuses/neonates, both prenatally and
postnatally.
Study design
A longitudinal prospective cohort study, conducted at the Department of
Obstetrics and Gynaecology (Division of Fetal Medicine) and the Department of
Paediatrics (Division of Paediatric Cardiology and Division of Neonatology) of
the Erasmus Medical Centre Rotterdam.
Study burden and risks
Burden associated with participation exists for the group with healthy fetuses
of two (additional) prenatal investigations and one (additional) postnatal
investigation. For the group with fetuses with a structural heart disease the
burden exists of one (additional) prenatal investigation and for the group of
fetuses with a growth restriction, the burden exists of one (additional)
postnatal investigation. All investigations have an estimated time of 15-30
minutes. Ultrasound can be safely used in pregnancy (Doppler ultrasound can be
safely used from 11 weeks in pregnancy). There is no risk associated with
participation for mother and fetus. There is no individual benefit for
participants.
Hogerbeetsstraat 19C
Rotterdam 3039XH
NL
Hogerbeetsstraat 19C
Rotterdam 3039XH
NL
Listed location countries
Age
Inclusion criteria
- Informed consent - Sufficient command of the Dutch language - A pregnancy
with a fetus with a structural heart disease, or - A pregnancy with a fetus
with an FGR (defined as: weight and/or abdominal circumference p<10, or
deviating growth (weight and/or abdominal circumference) > 20 percentiles, and
Doppler abnormalities in either the umbilical artery, the uterine artery or the
medial cerebral artery), or - A pregnancy with a healthy fetus (without any
major fetal congenital abnormality)
Exclusion criteria
- Multiple pregnancy
- A pregnancy with known fetal genetic abnormality
- A pregnancy with other major fetal congenital abnormalities
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 |
---|---|
ClinicalTrials.gov | NCTnummervolgt. |
CCMO | NL80033.078.21 |