OC16.06: Health related quality of life and healthcare costs of first trimester 3D VR ultrasound: the VR FETUS study

Many congenital anomalies can already be detected during the first trimester of pregnancy using ultrasound techniques with concomitant implications for diagnostics, counselling and follow-up for future parents (e.g. early reassurance). Three-dimensional ultrasound and Virtual Reality (VR) as innovative technology provide improved visualisation and possible improved detection of congenital anomalies. Performing a multicentre randomised clinical trial (RCT), we aimed to compare health-related quality of life (HRQoL) and healthcare costs in pregnant women who, in addition to the standard regimen, underwent an additional 3D VR first trimester anomaly scan (FTAS). Women with a high risk for congenital anomalies were included. Participants were randomly assigned to the control arm (second trimester anomaly scan (STAS) or the intervention arm (STAS + additional 3D VR FTAS). The HRQoL was assessed at 4 different moments during pregnancy, using validated questionnaires on anxiety, depression and health status. Only direct healthcare costs were assessed. 1,683 participants were randomised and 1,647 were eligible for analysis. Regarding HRQoL, there was a significantly lower state anxiety in the intervention group (βSTAI = -0.358, 95% CI -0.692; -0.024, p = 0.035). There was a trend towards lower depression and anxiety scores (βHADS-depression=-0.273, 95% CI -0.600;0.055, p = 0.103; βHADS-anxiety=-0.045, 95% CI -0.094;0.004, p = 0.072). The healthcare costs showed no significant difference (control vs. intervention: €7916 vs. €7938, p = 0.941). Compared to care as usual, an additional 3D VR FTAS significantly lowers anxiety scores and does not increase the total healthcare costs. These results favour implementation of 3D VR FTAS in a high-risk population.