fetal heart deformation fetal growth restricion fetal heart development foetaal hart en de ontwikkeling van de functie van het hart. foetale groeivertraging
Conditions
Interventions
not applicable
observational study
A DICOM of the fetal heart wil be performed, offline analysis and measuement of fetal heart deformation values per gestational age will be performed. these measurements do not hav
we study the normal development.
Sponsors
Máxima Medical Center, Board of Management
Board of Management Máxima Medical Center (in Dutch: Raad van Bestuur
Eligibility
Inclusion criteria
Inclusion criteria: -Singleton pregnancy -Age >18 years -No suspicion of congenital anomalies that coul d possibly interfere with fetal cardiac function at anomaly scan -Pregnancies complicated with gestational diabetes (GDM), Fetal growth restriction (FGR) or maternal hypertensive disease, defined as: GDM: Hyperglycemia occurring after 20 weeks gestational age. Diagnosis by 75 gram oral glucoses tolerance test; at least one elevated measurement from two measurements taken after fasting > 8 hours followed by 75 gram glucoses taken; first measurement> 7.0 mmol/l and/ or measurement after 2 hours > 7.8 mmol/l Maternal hypertensive disease, including: Pregnancy induced hypertension (PIH); systolic blood pressure >140mmHg and/ or diastolic blood pressure >90mmHg occurring after 20 weeks gestational age Pre-eclampsia (PE): hypertension as defined above and proteinuria (>300mg/24h) HELLP syndrome: combination of hemolysis (LDH >600 U/L, haptoglobin70 U/L) and low platelets (19 weeks
Exclusion criteria
Exclusion criteria: -Multiple pregnancies -Age <18 years -Suspicion of congenital anomalies that could possibly interfere with fetal cardiac function. -Fetal cardiac arrhythmia -Pre-existent maternal disease that might influence on fetal development; including diabetes mellitus, pre-existent hypertensive disease, auto-immune disease -Insufficient understanding of Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this longitudinal cohort study, the main study parameter is the determination of normal values of fetal myocardial deformation with increasing gestation. Normal values of fetal myocardial deformation that can be obtained: Strain (%) Strain rate (1/strain) Velocity (cm/s) Dyssynchrony (ms) Sphericity index Shortening fraction (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fetal myocardial deformation values in complicated pregnancies (i.e pregnancies complicated with gestational diabetes, fetal growth restriction, maternal hypertensive disease in pregnancy), will be compared to the values in uncomplicated pregnancies in an explorative pilot study. Inter-and intra-observer variability will be examined and limits of agreement will be assessed. Analysis of the images will be performed offline by 2 different researchers who are blinded for each other’s results. All the images will be examined twice by the same examiner, leaving 4 weeks in between the examinations so the examiner will be blinded for the first results. | — |
Contacts
Public ContactN.H.M. van Oostrum
Outcome results
None listed