Ultrasound Algorithms for Pregnancy

(MOBUS Trial)

Not yet recruiting at 1 trial location

Overseen By Reshma Rajan-Joy, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Caption Health, Inc.

Disqualifiers: Unable to consent, Compromised care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather ultrasound images from both pregnant and non-pregnant individuals to develop smart computer algorithms. These algorithms are designed to improve future ultrasound interpretation. Pregnant participants will undergo a standard ultrasound and an additional research scan, while non-pregnant participants will have only the research scan. Individuals who are currently pregnant or not pregnant and can consent to the study might be suitable candidates. As an unphased trial, participants can contribute to groundbreaking research that enhances future ultrasound technology.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the trial involves only ultrasound scans.

What prior data suggests that this ultrasound scan is safe for participants?

Research has shown that ultrasound scans during pregnancy are generally safe. A review by the World Health Organization found no connection between ultrasounds and negative effects on mothers or babies. Other studies have not identified any harmful effects on babies, such as growth or brain development issues, from these scans. When performed by trained professionals, ultrasounds are safe and well-tolerated for both pregnant and non-pregnant individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced ultrasound algorithms to potentially improve pregnancy care. Unlike traditional ultrasound methods that provide standard imaging, the research ultrasound in this trial aims to enhance image quality and diagnostic accuracy through innovative algorithms. This could lead to earlier detection of potential issues during pregnancy and offer more detailed information for both pregnant and non-pregnant participants. If successful, these advancements could represent a significant leap forward in prenatal care technology, providing more precise and reliable insights.

What evidence suggests that this ultrasound algorithm is effective for pregnancy?

This trial will compare ultrasound scans in pregnant and non-pregnant subjects. Research has shown that using ultrasound scans during the first trimester, along with follow-up scans, can greatly improve pregnancy outcomes. Specifically, women who underwent these scans experienced better results. While ultrasound is generally safe, some studies have suggested possible effects like low birth weight or delayed speech. It's important to note that frequent ultrasounds during pregnancy might slightly affect the baby's growth. Overall, using ultrasound in pregnancy is well-supported because it provides crucial information about the baby's development and health. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who consent to participate in research ultrasound scans. The study aims to gather data from both pregnant and non-pregnant participants across various sites.

Inclusion Criteria

I am 18 or older, not pregnant, and have given written consent.

I am 18 or older, pregnant, and have consented to participate.

Exclusion Criteria

Joining this study won't delay or harm my current care.

I am able to understand and provide written consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants undergo research ultrasound scans to collect data for algorithm development

9 months

1 visit (in-person) for non-pregnant subjects, 2 visits (in-person) for pregnant subjects

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Research Ultrasound scan

Trial Overview The intervention being studied is a research ultrasound scan. This clinical trial will collect ultrasound images and data to help train and validate artificial intelligence algorithms designed by the sponsor of the study.

How Is the Trial Designed?

Group I: Group 2- Non pregnant Subjects Experimental Treatment 1 Intervention

This group is for non-pregnant subjects. They will have one ultrasound scan performed- it will be the research scan

Group II: Group 1: Pregnant Subjects Experimental Treatment 1 Intervention

This group is for pregnant subjects. They will have two ultrasound scans performed- One will be the standard of care ultrasound scan and the other will be research scan

Who Is Running the Clinical Trial?

Caption Health, Inc.

Lead Sponsor

Trials

6

Recruited

1,200+

Published Research Related to This Trial

A new framework for monitoring adverse events (AEs) in pregnancy trials has been developed, which includes specific definitions and severity grading for both maternal and fetal AEs, enhancing safety assessments for drugs and interventions.

The framework was created through a comprehensive literature review and consensus from an international group of experts, resulting in 12 maternal and 19 fetal AE definitions that can be systematically applied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Spencer, RN., Hecher, K., Norman, G., et al.[2022]

In a study of 796 women undergoing reproductive surgery, the overall rate of adverse events (AEs) was 6%, with 12 of these events deemed preventable, highlighting the importance of monitoring for safety in surgical settings.

The duration of surgery was identified as a significant risk factor for AEs, with longer surgeries increasing the likelihood of complications, suggesting that surgical time management could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome monitoring in a reproductive surgery unit: a prospective cohort study in 796 patients. Bentz, EK., Imhof, M., Pateisky, N., et al.[2009]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

A quality improvement initiative in 14 hospitals led to a significant increase in the adoption of standardized care processes in perinatal units, rising from 38% to 81% between 2008 and 2012, which is crucial for enhancing safety practices.

The study found a 14% reduction in adverse outcomes, indicating that implementing multiple integrated strategies, including teamwork training and standardized care, can effectively improve perinatal safety and reduce harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback. Riley, W., Begun, JW., Meredith, L., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11954567/

Assessing the Role of Ultrasound Scanning in Improving ... The study revealed that women who underwent a first-trimester ultrasound with one or two additional scans had significantly higher odds of improved pregnancy ...

2. aium.org aium.org/resources/official-statements/view/prudent-use-and-safety-of-diagnostic-ultrasound-in-pregnancy

Prudent Use and Safety of Diagnostic Ultrasound in ... Some studies have reported effects of exposure to diagnostic ultrasound during pregnancy, such as low birth weight, delayed speech, dyslexia, and non–right- ...

3. ajog.org ajog.org/article/S0002-9378(24)00578-7/fulltext

Accuracy of antenatal ultrasound in predicting large-for- ... First, the overall LGA detection rate was 65.1%, with an FP rate of 8.6% and a PPV of 41.0%. However, this was in a cohort in which most ...

4. nature.com nature.com/articles/s41598-024-67744-w

The predictive value of ultrasound markers for pregnancy ... In summary, our findings suggest that a higher level of progesterone in the fifth gestation week is beneficial to pregnancy outcomes. Human ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673604175168

Effects of repeated prenatal ultrasound examinations on ... Exposure to multiple prenatal ultrasound examinations from 18 weeks' gestation onwards might be associated with a small effect on fetal growth.

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.6328

Safety of ultrasonography in pregnancy: WHO systematic ... Ultrasonography in pregnancy was not associated with adverse maternal or perinatal outcome, impaired physical or neurological development, increased risk for ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12071478/

The safety of prenatal ultrasound exposure in human studies Some of the reported effects include growth restriction, delayed speech, dyslexia, and non-right-handedness associated with ultrasound exposure.

8. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/guidelines-for-diagnostic-imaging-during-pregnancy-and-lactation

Guidelines for Diagnostic Imaging During Pregnancy and ... There have been no reports of documented adverse fetal effects for diagnostic ultrasonography procedures, including duplex Doppler imaging. The U.S. Food and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211501004699

Ultrasound in obstetrics: a review of safety Current data indicate that diagnostic ultrasound is safe throughout pregnancy when performed by trained individuals using appropriate equipment [20–22]. Color ...