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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50508

Enrollment

2810

Registered

2017-01-16

Start date

2017-07-06

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital anomalies

Interventions

None listed

Eligibility

Inclusion criteria

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 (

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results