Pregnancy
Conditions
Brief summary
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.
Interventions
DEVICEDiagnostic Ultrasound System
Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
Sponsors
United Imaging Healthcare North America, Inc.
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Pregnant persons age 18-45 years 2. Single intrauterine pregnancy 3. Gestational duration: 18 - 28 weeks
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.). 2. Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention. 3. Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging: * Body Mass Index (BMI) \> 40 * Prior surgeries including: abdominal mesh placement; abdominoplasty * Vaginal bleeding within the last 6 weeks 4. Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma. 5. Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids 6. Non-English speaking. 7. Participants deemed unsuitable by the investigator due to safety or data integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Fetal Biometric Image Set Collection | Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reference Dataset Creation | Within 4 months of study completion | 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 |
| Incidence of Adverse Events | Throughout study participation, up to 4 months | Nature, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), including device-related complications and study discontinuations |
Countries
United States
Contacts
CONTACTAdam Principal Investigator, MD, MPH
Outcome results
None listed