Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05423665
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2022-05-31
Brief Title:
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEART
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 its diagnosed in 197 of the cases and in dichorionic DC twin pregnancies in 105 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 its 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 eg black carbon during the pregnancy can reach the placenta and lead to alterations in the placentas 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None