Clinical Data Collection for Obstetric Ultrasound Algorithms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Research Ultrasound scan.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Data Collection for Developing Machine Learning-assisted Obstetric Ultrasound (MOBUS) Screening Algorithms
Overview
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
Detailed description
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
Th
Interventions
- Device Research Ultrasound scan
Both the study groups will be asked to undergo a research scan performed by an FDA approved ultrasound device
Primary outcome measures
- Research sweep Ultrasound Images (Vscan ) from the participants will be assessed for quality of images and comparing with patient chart history [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
Pregnant group (Group 1)
- Participants aged 18 years or older at time of consent.
- Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
- Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
- Participants who provide written consent.
Non-pregnant group (Group 2)
- Participants aged 18 years or older at time of consent.
- Participants who are not actively pregnant (confirmed using an HCG urine test strip).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- University of Minnesota — Minneapolis
- Baylor College of Medicine — Houston
Identifiers
NCT: NCT06742229 · CAP-MOBUS-24-02