This proposal aims to evaluate the use of STE as a diagnostic tool for early diagnosis of impaired fetal growth in twins. The results from this proposal will be beneficial from a public health perspective, as it will lead to accurate and early…
ID
Source
Brief title
Condition
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* to evaluate speckle tracking echocardiography in twin pregnancy
* to create reference values of strain and strain rate during twin pregnancy.
Secondary outcome
* to evaluate speckle tracking echocardiography as a tool for early diagnosis
of impaired fetal growth in twin gestations
* to investigate the intra-pair differences in fetal growth and cardiac
remodeling in twin pregnancy
* to compare cardiac remodeling between singletons and twin pregnancies
* to investigate the association between placenta functioning and in utero
cardiac remodeling.
* to explore in utero cardiac remodeling in association with neonatal
cardiovascular health
* to explore the association between maternal and/or fetal complications
and deviating deformation paramters.
Background summary
Fetal growth restriction (FGR) occurs in 5-10% of the pregnancies and up to two
times more in twins than singletons. Early detection during pregnancy is of
vital importance to provide optimal care. Still, less than 25% of the FGR cases
are currently detected before birth, and hence, optimal care cannot be given.
As a result, FGR is the second leading cause of perinatal morbidity and
mortality. It has been associated with a four-fold higher risk of fetal and
neonatal complications and a lifelong increased risk for health problems,
especially in twins. Diagnosis of FGR during pregnancy is currently based on
fetal biometry in combination with Doppler ultrasound. Nevertheless, accurate
detection remains difficult due to the small size of the fetal heart and the
fetal position and movement. Furthermore, the current techniques do not allow
antenatal differentiation between constitutionally small fetuses, who do not
require ante- or postnatal care adjustments, and fetuses who are growth
restricted due to a pathological cause and who do require intensive care.
Study objective
This proposal aims to evaluate the use of STE as a diagnostic tool for early
diagnosis of impaired fetal growth in twins. The results from this proposal
will be beneficial from a public health perspective, as it will lead to
accurate and early diagnosis of FGR with subsequent antenatal and postnatal
care adjustments, and hence, decreased morbidity and mortality. First we have
to explore if speckle tracking echocardiography can be used in twin pregnancies
and if so, we have to set up reference values of normal growth during twin
pregnancy.
Study design
In this prospective study there are 2 time points during the pregnancy
included, namely at 21 weeks and 30 weeks of gestation, to measure the
predictive values of FGR, strain and strain rate. The fetal growth parameters
will be collected at the same time points, to define the growth (differences)
throughout gestation of both fetuses.
Study burden and risks
The burden and risk associated with the participation is extremly low.
At 21 weeks gestation, a blood sample is taken for the study. The patient can
have a bruise due to the procedure of blood sampling.
Corneel Heymanslaan 10
Gent 9000
NL
Corneel Heymanslaan 10
Gent 9000
NL
Listed location countries
Age
Inclusion criteria
dichorionic twin pregnancy
gestational age of 21 weeks at the first study visit
Women >= 18 years
Exclusion criteria
Women pregnant of multiples of higher order (>=3 siblings)
Monochorionic twin pregnancy
Fetal arrhythmia
Known fetal congenital or genetic abnormalities
Any suspicion of congenital fetal anomalies that might influence fetal cardiac
function
Pre-existing maternal hypertensive disease
Autoimmune disease including systemic lupus erythematosus
History of stillbirth
Diabetes mellitus (mother)
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 | NCT05423665 |
| CCMO | NL85315.015.23 |