Virtual Reality & Feasibility and Efficacy of first Trimester Ultrasound: a randomized controlled trial.

Completed

• Conditions: 10010273; Congenital anomalies

• Registration Number: NL-OMON50508
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2810

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Detection rates of congenital anomalies when 3D VR is used in the first<br /><br>trimester compared to 2D ultrasound examination in the second trimester of<br /><br>pregnancy when applied in a high risk population. Follow-up data (pregnancy<br /><br>outcome) will be collected (which is currently standard care) together with the<br /><br>clinical investigation of the neonate (post mortem examination = *Golden<br /><br>Standard*). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Health related quality of life (physical, mental, emotional and social<br /><br>functioning) in terms of QALY*s (maternal perspective).<br /><br>Cost-effectiveness (costs per detected anomaly from a societal perspective).</p><br>