Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05601375 |
| Other study ID # |
NL80033.078.21/STIPP-study |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2022 |
| Est. completion date |
September 12, 2025 |
Study information
| Verified date |
October 2022 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Comparison of prenatal and postnatal cardiac function assessed by echocardiography using
pulsed wave Doppler, Tissue Doppler and speckle tracking (strain and strain rate) between
foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and
healthy fetuses/neonates.
Description:
Rationale:
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
speckletracking (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.
Objective: Comparison cardiac function assessed by echocardiography using 2-D, 3-D, pulsed
wave Doppler, Tissue Doppler and speckle tracking (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 population: Women, aged ≥16 years, with a singleton pregnancy with either a healthy
fetus, a fetus with an fetal growth restriction or a fetus with structural heart disease.
Main study parameters/endpoints:
Comparison of fetal systolic and diastolic function in fetuses with a structural heart
disease, fetuses with an FGR and healthy fetuses, using speckle tracking, pulsed waved
Doppler and tissue Doppler, at multiple time points in the pregnancy and within 72 hours
postpartum.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: 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.
