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Clinical Trials in the Netherlands / NCT05423665
Recruiting Observational

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

NCT05423665 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2023-06-22
Last updated
2026-09-21

Condition(s) studied

Fetal Growth RestrictionCardiac Remodeling, VentricularPlacental InsufficiencyAir Pollution

Investigational drug(s) / intervention(s)

sample collection

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Ghent University Hospital Ghent Belgium Recruiting
Universitair ziekenhuis Leuven Leuven Belgium Not Yet Recruiting
Maxima medical center Eindhoven Netherlands Not Yet Recruiting

More University Hospital, Ghent trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05423665 on ClinicalTrials.gov ↗ ← All trials in the Netherlands