A new method, implemented in the I-Space Virtual Reality application, will be tested on its reproducibility and validity. It will be used to describe fetal movement patterns. This new method can improve the rapidity of fetal movement studies and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Zwangerschap - ontwikkeling van beweging bij de foetus
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is a pilot study to investigate the validity and reproducibility of our
newly introduced automated movement measuring method using 4D ultrasound and
Virtual Reality. The reproducibility and validity of the newly introduced
movement measuring method in Virtual Reality will be studied.
Secondary outcome
Movement patterns will be described using volume automated replacement
techniques. Movements will be described and analyzed: type of movements
(qualitative), movement patterns (including angle of movement, amount of
movement = quantitative), time that fetuses move compared to resting moments.
Movement patterns will be compared to movement patterns described in other
studies using 2D ultrasound.
Background summary
Optimal embryonic development is of crucial importance throughout life. At 9
weeks gestational age more complex movements appear, in which all body parts
participate. Until now two-dimensional (2D) and three-dimensional (3D) vaginal
and abdominal ultrasound data are used to study early fetal movement patterns.
The I-Space Virtual Reality application allows depth perception and real 3D and
four-dimensional (4D) visualization. Movement patterns can be analyzed easier
and in more detail, with this method. Secondary, the analysis of the movements
will be faster using a new method of analysis.
Study objective
A new method, implemented in the I-Space Virtual Reality application, will be
tested on its reproducibility and validity. It will be used to describe fetal
movement patterns. This new method can improve the rapidity of fetal movement
studies and allows to study the movement patterns in more detail. Normal fetal
movement patterns will be described.
Study design
This will be a prospective observational pilot study.
Study burden and risks
One 4D vaginal ultrasound will be performed at 10 weeks of gestation. The total
transvaginal scanning time will be kept as short as possible (maximum of 30
minutes) and will follow ISUOG recommendations (2013). No additional risks are
to be expected from this ultrasound examination.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Healthy pregnant woman who conceived spontaneously from a singleton pregnancy.
- Age * 18 years.
- Gestational age of 10 weeks, confirmed by CRL measurement earlier in pregnancy.
- Sufficient knowledge of the Dutch language.
- Signed informed consent.
Exclusion criteria
- Unknown or uncertain gestational age.
- Pregnancy with overt congenital abnormalities.
- Multiple pregnancy.
- High risk pregnancy.
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 | NL54526.078.15 |