An observational study in Fetal Growth Restriction, Cardiac Remodeling, Ventricular and Placental Insufficiency, sponsored by University Hospital, Ghent. Recruiting at 3 sites in 2 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University Hospital, Ghent · Observational
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.
Fetal growth restriction (FGR) is diagnosed in 5-10% of the pregnancies. After preterm birth, it is the second leading cause of perinatal morbidity and mortality. Twin pregnancies have a higher occurrence of FGR than singletons, in monochorionic (MC) twin pregnancies it's diagnosed in 19.7% of the cases and in dichorionic (DC) twin pregnancies in 10.5% of the cases. Fetuses with FGR are at greater risk of perinatal morbidity and mortality and even long-term health defects. From a public health perspective, it's important to correctly diagnose FGR to adjust the antenatal and postnatal care and to have more insight into the factors influencing early onset cardiovascular disease. STE has a strong predictive value for cardiovascular function, therefore it would be a promising tool to add in the routine pregnancy clinical care. Speckle tracking echocardiography (STE) is a relative new technique especially in the pregnancy follow up, which permits offline calculation of myocardial velocities and deformation parameters. These parameters, including strain and strain rate, provide information about the fetal myocardial function. Apart from investigating if STE can be used for the prediction of FGR, we will also investigate the association between fetal exposure to air pollution and in utero cardiac remodeling. Indeed, it is known that inhalation of particulate matter (e.g. black carbon) during the pregnancy can reach the placenta and lead to alterations in the placenta's function including increases in oxidative stress markers. Early life exposure to black carbon has been associated with adverse cardiovascular health outcomes and reduction of fetal growth, especially in multiple gestation pregnancies.
In this project we will include 2 time points during the pregnancy, 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 20 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.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's planned enrollment of 360 is above the median of 200 across 145 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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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:
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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Observation of cardiac remodeling perinatal and postnatal
Other: sample collection
Observation of cardiac remodeling perinatal and postnatal
Other: sample collection
blood 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
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
Time frame: Prenatal to 1-3 days after birth
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
Time frame: Prenatal to 1-3 days after birth
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
Time frame: Prenatal to 1-3 days after birth
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
Time frame: Prenatal to 1-3 days after birth
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
Time frame: Prenatal to 1-3 days after birth
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
Time frame: Prenatal to 1-3 days after birth
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)
Time frame: Prenatal to 1-3 days after birth
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