Fetal myocardial deformation throughout pregnancy
- Conditions
- fetal heart deformationfetal growth restricionfetal heart developmentfoetaal hart en de ontwikkeling van de functie van het hart.foetale groeivertraging
- Registration Number
- NL-OMON20837
- Lead Sponsor
- Máxima Medical Center, Board of ManagementBoard of Management Máxima Medical Center (in Dutch: Raad van Bestuur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Singleton pregnancy
-Age >18 years
Exclusion Criteria
-Multiple pregnancies
-Age <18 years
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In this longitudinal cohort study, the main study parameter is the determination of normal values of fetal myocardial deformation with increasing gestation. <br /><br /><br><br>Normal values of fetal myocardial deformation that can be obtained:<br /><br>Strain (%)<br /><br>Strain rate (1/strain)<br /><br>Velocity (cm/s)<br /><br>Dyssynchrony (ms)<br /><br>Sphericity index <br /><br>Shortening fraction (%)<br>
- Secondary Outcome Measures
Name Time Method 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. <br><br /><br /><br>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.<br>