Clinical Data Collection for Obstetric Ultrasound Algorithms

Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms

The goal of this clinical trial is to

• Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites.
• Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor

Consented participants will be asked to take part in a research ultrasound scan

In this study pregnant and no pregnant subjects will be recruited from Obstetrics and Gynecology clinics/hospitals or from Maternal and Fetal Medicine centers. The pregnant subjects will be in Group 1 and non pregnant subjects will be in Group 2. Pregnant subjects are only recruited if they are scheduled for an obstetric standard of care scan . Both the group will undergo research scan, which is a sweep protocol using handheld FDA approved ultrasound device like Vscan. Patient chart history (no PHI), standard of care scan ultrasound images (no PHI), and research scan ultrasound images (no PHI) would be obtained from Group 1 subjects. Patient history (no PHI), research ultrasound images (no PHI) would be obtained from Group 2 subjects The data collected from this study will be used by the sponsor to develop algorithms for screening various fetal health parameters such as gestational age, placenta location, fetal heart rate, number of fetuses, fetal positions etc

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Inclusion Criteria:

Pregnant group (Group 1)

1. Participants aged 18 years or older at time of consent.
2. Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
3. Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
4. Participants who provide written consent.

Non-pregnant group (Group 2)

1. Participants aged 18 years or older at time of consent.
2. Participants who are not actively pregnant (confirmed using an HCG urine test strip).
3. Participants who provide written informed consent.

Exclusion Criteria:

- 1. Participants for whom participating in this study would delay or compromise care in any way.

2. Participants who are not able to understand or provide written consent.