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Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies

Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05423665
Acronym
HEART
Enrollment
360
Registered
2022-06-21
Start date
2023-06-22
Completion date
2028-02-01
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Pollution, Cardiac Remodeling, Ventricular, Fetal Growth Restriction, Placental Insufficiency

Brief summary

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.

Detailed description

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.

Interventions

OTHERsample 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

Sponsors

Maxima Medical Center
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
Hasselt University
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

Inclusion criteria

* Singleton or dichorionic twin pregnancy * Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first 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 outcomes

Primary

MeasureTime frameDescription
To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestationsPrenatal to 1-3 days after birthto 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.Prenatal to 1-3 days after birthto 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 pregnanciesPrenatal to 1-3 days after birthto compare the changes in strain and strain rate between singletons and twin pregnancies

Secondary

MeasureTime frameDescription
To investigate the association between placenta functioning and in utero cardiac remodelingPrenatal to 1-3 days after birthto evaluate placenta insufficiency (Doppler ultrasound, biochemical marker) with strain and strain rate
To investigate placenta functioning as a mediator between air pollution and cardiac remodelingPrenatal to 1-3 days after birthTo evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with placenta insufficiency (biochemical marker, Doppler ultrasound)
To explore in utero cardiac remodeling in association with neonatal cardiovascular healthPrenatal to 1-3 days after birthto 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 remodelingPrenatal to 1-3 days after birthto evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with strain and strain rate

Countries

Belgium, Netherlands

Contacts

Primary ContactEline Meireson
eline.meireson@uzgent.be0032 9 332 78 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026