To investigate whether 3D VR ultrasound is of additional value in the detection of fetal anomalies in the first trimester when compared to the 2D ultrasound scan in the second trimester of pregnancy (=usual care) within a high risk population.…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection rates of congenital anomalies when 3D VR is used in the first
trimester compared to 2D ultrasound examination in the second trimester of
pregnancy when applied in a high risk population. Follow-up data (pregnancy
outcome) will be collected (which is currently standard care) together with the
clinical investigation of the neonate (post mortem examination = *Golden
Standard*).
Secondary outcome
Health related quality of life (physical, mental, emotional and social
functioning) in terms of QALY*s (maternal perspective).
Cost-effectiveness (costs per detected anomaly from a societal perspective).
Background summary
A considerable amount of fetal anomalies can already be detected by ultrasound
by the end of the first trimester. Within the Erasmus MC, a new technique has
been developed, using virtual reality (VR) displays, enabling three dimensional
(3D) depth perception and interaction. This new system provides a validated and
reliable method for measuring embryonic development and can be used in daily
outpatient practice. It is assumed that 3D VR in the first trimester has a
diagnostic accuracy comparable to the two dimensional (2D) scan in the second
trimester. 3D VR might be of additional value in the detection of anomalies in
case of a comparable diagnostic accuracy as the golden standard. This may
result in an improvement of the health related quality of life and adjustment
of treatment strategies.
Study objective
To investigate whether 3D VR ultrasound is of additional value in the detection
of fetal anomalies in the first trimester when compared to the 2D ultrasound
scan in the second trimester of pregnancy (=usual care) within a high risk
population. Moreover, it will be investigated whether the results of the 3D VR
first trimester scan are of value in terms of diagnostic accuracy.
Additionally, it needs to be clear whether the use of 3D VR ultrasound is of
benefit for the pregnant population with respect to psychological burden/stress
and treatment options (health-related quality of life). Finally,
cost-effectiveness (in terms of health gain) of this new diagnostic modality
will be evaluated (health care perspective as well as societal perspective).
Study design
Multicentre, randomized controlled trial.
Study burden and risks
Patients who are in the 3D VR ultrasound arm, will pay one extra visit to the
department of Prenatal Diagnosis of the Erasmus MC between 11+0 and 13+6 weeks
GA to undergo a transvaginal or transabdominal ultrasound examination. This
examination will take around 30-45 minutes. All participants will fill in
various questionnaires. The SF36, HADS, STAI questionnaires, the Thermometer
tool will be filled out at different time points (Appendix L). The newly
developed questionnaire will be filled out at the same time period.
Additionally, all participants will fill in a list (MCQ) with all the medical
expenses they make twice.
The study is a diagnostic study. Based on the information provided by this
study, patients can even opt to terminate their pregnancy. This is not
different from clinical standard care.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Inclusion criteria
- Women above 18 years of age.
- Viable pregnancy, including multiple pregnancies.
- Sufficient understanding of the Dutch language (written and spoken).
- Pregnant women in the first trimester of pregnancy with a high risk of having
a fetus with an anomaly (<= high risk population).
Exclusion criteria
- Women under 18 years of age.
- Non-viable pregnancy.
- No sufficient understanding of the Dutch language.
- Detection of an anomaly in the current pregnancy before randomization.
- In case of pregnancy duration > 13+6 weeks.
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 | NL58563.078.16 |
| OMON | NL-OMON28245 |