About this trial
In this project 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. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton or dichorionic twin pregnancy
Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit
Women ≥ 18 years
Disqualifiers
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
Trial population
The number of subjects that will be included in this study is: 600 neonates (200 twin pairs and 200 singletons) and 400 pregnant mothers. The fetuses are divided into following sub-groups: * Appropriately grown * Fetal growth restricted * Selective fetal growth restricted (specific for twins)
Trial design
Case-control
Prospective
Treatments tested in this trial
sample collection
Other interventionblood sample at 21 weeks of gestation clips of the fetal heart at 21 weeks of gestation, 30 weeks of gestation and 1-3 days after birth collection of umbilical cord blood at birth collection of the placenta at birth
Treatment groups
Trial outcomes
Primary outcomes
To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations
to determine the change in fetal strain and strain rate in twin pregnancies in comparison with fetal growth
To determine the intra-pair differences in fetal growth and strain (cardiac remodeling) in multiple gestations.
to compare changes in strain and strain rate with fetal growth within 1 twin pair
To compare the strain values (cardiac remodeling) between singletons and twin pregnancies
to compare the changes in strain and strain rate between singletons and twin pregnancies
Secondary outcomes
To investigate the association between placenta functioning and in utero cardiac remodeling
to evaluate placenta insufficiency (Doppler ultrasound, biochemical marker) with strain and strain rate
To explore in utero cardiac remodeling in association with neonatal cardiovascular health
to evaluate strain and strain rate with the neonatale blood pressure and heart rate
To study the association between prenatal air pollution exposure and in utero cardiac remodeling
to evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with strain and strain rate
To investigate placenta functioning as a mediator between air pollution and cardiac remodeling
To evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with placenta insufficiency (biochemical marker, Doppler ultrasound)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
KU Leuven
Collaborator
Maxima Medical Center
Collaborator
Hasselt University
Collaborator