The primary objective of this study will be to investigate reproducibility of ROI-TDI for fetal cardial performance in a group of normal pregnancies, and compare this new proposed parameter with the Myocardial Performance Index. The data will be…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of this study is the new parameter for fetal cardial
performance using ROI-TDI with MPI
Secondary outcome
Secundary outcome is to generate normal values for the new parameter in a
group of normal pregnancies.
Background summary
Congenital heart disease is the most common disorder found in new-borns. With
upcoming techniques for fetal echocardiography antenatal detection rate is
rising, but still a reproducible technique for fetal heart function is not
available. Myocardial Performance Index (MPI) generated from pulsed wave
Doppler is the most used parameter to define fetal cardiac function, but is
limited because of the high interobserver variability.
Color Tissue Doppler Imaging (TDI) and Speckle Tracking in the Foetal heart is
a relatively new and promising technique in foetal diagnostic echocardiography,
but has been reported with various results and seems not routinely applicable
with limited frame rates (30Fr/s). Toshiba Aplio provides Raw Data Storage with
acoustic Frame rates (>100Fr/s) to allow a higher spatial resolution and
probably more accurate detection. Using Speckle Tracking a new proposed
parameter for cardial performance can be extracted with a higher
reproducibility and lower inter and intraoberserver variability, and therefore
be an aid in early detection of fetal cardiac dysfunction.
Study objective
The primary objective of this study will be to investigate reproducibility of
ROI-TDI for fetal cardial performance in a group of normal pregnancies, and
compare this new proposed parameter with the Myocardial Performance Index. The
data will be used as well to generate normal values for the new performance
parameter, and define the minimum duration of gestation for ROI-TDI approach.
Study design
Longitudinal prospective approach.
Participating women will receive a short ultrasound examination 4-5weekly (10
minutes), starting from 16 weeks of gestational age up to the third trimester,
in total 4 exams will be done. These ultrasounds will be focused on cardiac
function including a color-TDI clip of 2,5 seconds, and fetal biometry.
Measurements will be generated off line at a later stadium.
Study burden and risks
Extra ultrasound examinations are performed 4-5 weekly in the LUMC. Except for
the time needed for the exam , this study does not add interventions, so no
additional risks are present. Patient data needed for analysis will be
withdrawn from the patient file, no questionnaires are added. Our study will
not influence the standard care. All patients are free to participate or to
exit the study at any moment during the study time.
A benefit for an individual woman is only of emotional character, the extra
ultrasound will provide the patient an echographic follow-up of her unborn
child and she will receive representative images after each ultrasound.
This study will contribute to find better antenatal parameters in measurement
of cardiac performance in foetuses. In the future, having better parameters for
cardiac performance might contribute to better prenatal care in pregnancies
where intervention might be needed for example when myocardial performance of
the foetus deteriorates, for example in cases of TTTS.
Borssenburgplein 7-3hg
Amsterdam 1078TW
NL
Borssenburgplein 7-3hg
Amsterdam 1078TW
NL
Listed location countries
Inclusion criteria
- Maternal age over 18 years
- Singleton uncomplicated pregnancy
- ability to give informed consent
Exclusion criteria
- Maternal diabetes
- Maternal hypertension / pre eclampsia
- Chromosomal or major congenital anomalies of the fetus
- Cardiac abnormalities of the fetus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50078.058.14 |