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First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial.

C S Pietersma1, A G M G J Mulders1, L M Moolenaar1

  • 1Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.

BMC Pregnancy and Childbirth
|September 7, 2020
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Summary

This study evaluates if first-trimester 3D Virtual Reality (VR) ultrasound improves fetal anomaly detection. Enhanced diagnostic capabilities may improve patient quality of life and inform healthcare policy.

Keywords:
Detection rateFetal anomaliesFirst trimesterTwo-dimensional ultrasound, three-dimensional ultrasoundVirtual reality

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Area of Science:

  • Medical Imaging
  • Fetal Medicine
  • Virtual Reality in Healthcare

Background:

  • First-trimester anomaly scans using 2D ultrasound are becoming standard care for early detection of fetal anomalies.
  • A novel Virtual Reality (VR) approach utilizing 3D ultrasound datasets has been developed to enhance diagnostic abilities.
  • This technology offers improved depth perception and interaction for assessing fetal development.

Purpose of the Study:

  • To investigate the added diagnostic value of first-trimester 3D VR ultrasound for detecting fetal anomalies.
  • To assess the impact on patients' health-related quality of life and the cost-effectiveness of the 3D VR modality.
  • To gather perspectives from both patients and ultrasonographers on the use of 3D VR ultrasound.

Main Methods:

  • A randomized controlled trial comparing standard second-trimester 2D ultrasound with an additional first-trimester 2D and 3D VR ultrasound.
  • Inclusion criteria: high-risk pregnancies in the first trimester for fetal congenital anomalies.
  • Outcomes measured: fetal anomaly detection rates (compared to neonatal/histopathological examination as gold standard), quality of life, healthcare expenses, and user perspectives.

Main Results:

  • The study aims to determine if first-trimester 3D VR ultrasound improves the detection rate of fetal anomalies compared to standard care.
  • Statistical power calculations indicate a required sample size of 2800 participants for significant results.
  • The primary outcome is the diagnostic accuracy of fetal anomaly detection.

Conclusions:

  • First-trimester 3D VR ultrasound has the potential to enhance patient quality of life through earlier reassurance or identification of malformations.
  • Study findings will provide crucial evidence on the cost-effectiveness of first-trimester ultrasound incorporating a 3D VR approach.
  • Results will inform policymakers and healthcare professionals regarding the integration of advanced ultrasound technologies.