Clinical Trial

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

Study acronym: HEART
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-06-14; most recent amendment 2023-09-25.
Status change: Not Yet Recruiting → Recruiting 2023-08-16
Trial Details
NCT Number NCT05423665
Lead Sponsor University Hospital, Ghent
Collaborators: KU Leuven, Maxima Medical Center, Hasselt University
Conditions Fetal Growth Restriction, Cardiac Remodeling, Ventricular, Placental Insufficiency, Air Pollution
Enrollment 360 participants
Start Date 2023-06-22
Primary Completion 2027-02-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2023-09-26