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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 29935 | Other Identifier | OHSU |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Participants | Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks of gestational age undergoing obstetric ultrasound at OHSU |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Ultrasound System | Device | Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete Fetal Biometric Image Set Collection | Number of participants from whom complete fetal biometric image sets are successfully collected, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), in compliance with the study scanning protocol standards | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Reference Dataset Creation | Completion of independent reviews by two qualified obstetricians, resolution of measurement discrepancies through adjudication, and establishment of final ground truth measurements for all collected biometric data | Within 4 months of study completion |
| Incidence of Adverse Events |
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Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.).
Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention.
Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging:
Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids
Non-English speaking.
Participants deemed unsuitable by the investigator due to safety or data integrity.
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Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks gestational age presenting for obstetric care at Oregon Health & Science University, Portland, Oregon
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Principal Investigator, MD, MPH | Contact | 503-494-6852 | crosland@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Perinatology and Genetics Clinic | Portland | Oregon | 97239 | United States |
This is a proprietary dataset for UIH's 510(k) submission and is not intended for public sharing
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Nature, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), including device-related complications and study discontinuations |
| Throughout study participation, up to 4 months |