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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 3/4/25 | Other Identifier | UW Madison | |
| A532860 | Other Identifier | UW Madison |
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The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 16 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.
Primary Objective:
Secondary Objectives:
The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 36 Weeks Pregnant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Backscatter Quantitative Ultrasound | Device | The intervention consists of a regular abdominal ultrasound scan for fetal evaluation. The difference with a regular scan is that the scanner used to image the fetus provides access to raw/unprocessed ultrasound echo data that can be extracted from the scanner and processed offline (after acquisition) to extract compute backscatter quantitative ultrasound (bQUS) features. Thus, data acquisition does not represent a significant departure from conventional fetal imaging protocols. Other than the time needed to acquire the images, the participant will not perceive any difference from a regular fetal ultrasound scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data | Phase 1 will provide evidence of the technical viability of data acquisition at the UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated. | data collected over a single study visit (up to 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Population Variance in Fetal Lung Microstructure | Populational variance σ^2_Pop: variance of the individual participant median value of a quantitative ultrasound feature q_(M,s) obtained from the N_S participants included in the analysis. | data collected over a single study visit (up to 30 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UW Ob/Gyn Human Subjects Core | Contact | 608-890-3345 | research.crc_obgyn@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| J. Igor Iruretagoyena, MD, MS | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meriter Hospital | Recruiting | Madison | Wisconsin | 53715 | United States |
Data sharing with external collaborators will be provided through FlyWheel Exchange.
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Coded data and the linking files will be stored for 7 years after conclusion of the study. After seven years, linking files and codes will be destroyed, and the de-identified data will be stored indefinitely for potential future research use.
Permission to access data will be provided within Data Sharing Agreements and only after IRB approval.
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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