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Clinical Trials in Sweden / NCT02583763
Active, not recruiting Observational

Cardiac Displacement From Third Trimester to Early Childhood

NCT02583763 · tracked via the Priya Life Science Sweden tracker
Sponsor
University Hospital, Linkoeping
Phase
Observational
Started
2013-01
Last updated
2025-03-28

Condition(s) studied

IUGRFetal Growth RetardationIntrauterine Growth Restriction

Investigational drug(s) / intervention(s)

EchocardiographyBlood sample

Echocardiography: During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyzes are performed off-line and analyzed by vector velocity imaging software.

Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 9 years of age.

Study summary

The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial function have for the neonate and the child during the first years of life.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Inclusion of research subjects: Growth restriction in routine pregnancy ultrasound, verified by specialist control. Gestational age based on Crown Rump Length measurements during the first trimester. Growth restriction defined by a deviation more than 22% from the normal curve at a given gestational age or growth rate deviates more than 10% compared to the previous measurement in relation to the expected weight. * Inclusion of controls: Control individuals recruited among mothers who come to routine pregnancy ultrasound control at gestational week 18. These are randomly selected and then asked to participate. Exclusion Criteria: * Exclusion of both the cases with IUGR and the control cases are major malformations, twin pregnancy, signs of intrauterine infection during pregnancy, significant illness or significant medical treatment of the mother.

Primary outcome measure(s)

  • Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm — After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age.
    Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. At each timepoint offline calculation were performed three times on each image and an averaged was calculated. The length of the heart from the level of the AV valve to the apex in left ventricle is used as a measurement for the size of the heart. As the velocity increases when the size of the heart increases a quota is used dividing the velocity by the length of the heart to be able to compare the velocity at different timepoints whe the child is growing. Quota=Left chamber velocity at septum stated in cm/s divided by ventricular length in mm.

Trial sites (2)

FacilityCityRegionStatus
Dept of Obstetrics and Gynecology Linköping Sweden
Paediatric Department University Hospital Linköping Sweden

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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 NCT02583763 on ClinicalTrials.gov ↗ ← All trials in Sweden