Instinct™ Ultrasound Device Safety, Efficacy and Usability

Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability

Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.

Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.

Inclusion Criteria:

• Age ≥ 18.
• Pregnancy week - 14-40.
• Fetus - single, no known genetic or anatomic defects.
• Able to understand and give informed consent.

Exclusion Criteria:

• Multiple pregnancy.
• Known genetic or anatomic defect to the fetus.
• Inability to understand how to operate the device or give informed