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Objective: To explore the effect of adding simulation-based transvaginal ultrasound training to trainees' clinical training compared with only clinical training on quality of and efficiency of care. Background: Simulation-based ultrasound training may be an effective adjunct to clinical training, but no studies have examined its effects on quality and efficiency of care. Methods: Trainees from 4 University Hospitals in East Denmark were included (N = 54). Participants were randomized to either simulation-based ultrasound training and clinical training (intervention group, n = 28), or to clinical training only (control group, n = 26).The primary outcome was patient-reported discomfort during transvaginal ultrasound examinations performed by study participants. Secondary outcomes included patient-reported perceived safety and confidence in ultrasound provider. Finally, the need for trainee supervision or repeated patient examinations was recorded. Results: In total, 1150 patient ratings were collected. The intervention was associated with a reduction of patient discomfort by 18.5% [95% confidence interval (CI), 10.7-25.5; P < 0.001), and with a 7.9% (95% CI, 0.5-14.7; P = 0.04) increase in perceived safety. The intervention group participants received 11.1% (95% CI, 2.5-18.9) higher scores on patients' confidence compared with control group participants (P = 0.01). When the number of days of clinical training was doubled, the odds for trainee supervision or repeated patient examination was reduced by 45.3% (95% CI, 33.5-55.1) and 19.8% (95% CI, 4.1-32.9) in the intervention and control group, respectively (P = 0.005). Conclusions: Simulation-based ultrasound training improved quality of care and reduced the need for repeated patient examination and trainee supervision. [ABSTRACT FROM AUTHOR]