To investigate the effect of increasing gestation on fetal myocardial deformation values.To explore fetal heart rate variability and fetal ECG waveform parameters in both healthy and growth-restricted fetuses, measured with non-invasive fetal…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Normal myocardial deformation values throughout gestation will be investigated.
Secondary outcome
Comparison of normal values of myocadial deformation throughout the pregnancy
with values of myocardial deformation as measured in complicated pregnancies.
Fetal heart rate variability and fetal ECG waveform parameters in healthy and
growth-restriced fetuses.
Background summary
Speckle tracking echocardiography (STE) offers the potential to measure
myocardial deformation. Myocardial deformation imaging has been demonstrated a
high sensitivity for detecting preclinical myocardial dysfunction in various
pathological conditions characterized in adults. STE in fetal cardiology is
still challenging but might be a good tool to predict fetal cardiac function
and fetal well-being, especially in pregnancies complicated by placental
dysfunction. Normative data for fetal myocardial deformation haven not been
comprehensively described in a longitudinal cohort. The effect of increasing
gestation on these values need further investigation in healthy, and in
complicated pregnancies before STE can be introduced in daily clinical
practice.
Fetal cardiac remodeling due to hypoxia also leads to decreased fetal heart
rate variability, which is an important parameter for fetal wellbeing.
Quantitative assessment of fetal heart rate variability is not possible with
the current method for fetal monitoring, cardiotocography, because it does not
provide beat-to-beat information on the fetal heart rate. The non-invasive
fetal electrocardiography technique however, can provide beat-to-beat
information on the fetal heart rate.
Study objective
To investigate the effect of increasing gestation on fetal myocardial
deformation values.
To explore fetal heart rate variability and fetal ECG waveform parameters in
both healthy and growth-restricted fetuses, measured with non-invasive fetal
electrocardiography.
Study design
Longitudinal prospective cohort study for uncomplicated pregnancies.
Explorative pilot case control study for pregnancies complicated with fetal
growth restriction, gestational diabetes and hypertensive disease.
Study burden and risks
No extend of burden nor risks for the participant to be expected.
There is no befenefit for the participant.
Ultrasound examinations will be performed on a 4 weekly base from 20 to 40
weeks gestational age (or until delivery if delivery occurs before 40 weeks
GA). Growth restricted fetuses will have a weekly ultrasound, included in their
regular follow up appointments.
fECG will be perfomred once in the healthy pregnant subject, it will be
perfomred on a weekly base in the growth restricted cohort.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
Pregnant women, uncomplicated pregnancy, singleton without suspicion of congenital anomalies.
Pregnant women, pregnancy complicated by fetal growth restriction, singleton without suspicion of congenital anomalies
Exclusion criteria
<18 years
multiple pregnancy
pre existent hypertensive disease or diabetes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64999.015.18 |
| Other | NTR: TC 7132 |
| OMON | NL-OMON20837 |