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Remote Fetal Monitoring for Pregnancy (SHOW-ME Trial)

Columbia, MO
N/A
Waitlist Available
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Be older than 18 years old
Must not have
Age <18 years
Abdominal skin disorder that prevents use of the INVO device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a remote fetal-monitoring system called NUVO at home, along with an app, is beneficial for pregnant patients who need weekly non-stress testing. They want to

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Who is the study for?
This trial is for pregnant individuals who need weekly non-stress tests. Participants will be randomly assigned to either test at home using the INVU system or in a clinic. They must complete surveys before and after the trial to measure satisfaction and cost.Check my eligibility
What is being tested?
The SHOW-ME Study is testing if the INVU remote fetal monitoring system can improve patient and provider satisfaction, as well as save costs compared to traditional in-clinic non-stress tests for pregnancy monitoring.See study design
What are the potential side effects?
Since this study involves non-invasive fetal monitoring, there are no direct side effects from the intervention itself. However, participants may experience inconvenience or technical issues with the equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I have a skin condition on my abdomen that prevents using certain medical devices.
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I am unable to give consent for my own medical treatment.
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My pregnancy has complications like FGR or placenta issues.
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I plan to change my healthcare provider during my pregnancy.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework
Secondary study objectives
Assess direct and indirect cost savings for patients, providers, and insurance carriers following implementation of a remote monitoring system

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: At-home fetal monitoringExperimental Treatment1 Intervention
Participants in this arm will be prescribed an INVU at-home fetal monitoring system. All training on the device use, troubleshooting, and accessing the cloud platform for telehealth (fetal) visits will be done by INVU through the INVU app. Non-stress testing will be done from home once or twice weekly as determined by provider at scheduled date and times.
Group II: In-office fetal monitoringActive Control1 Intervention
In this arm, typical standard of care in-office fetal monitoring visits will be done. Participants will have non-stress testing done in clinic once or twice weekly as determined by provider at scheduled date and times.

Find a Location

Closest Location:University of Missouri - Kansas City· Kansas City, MO· 199 miles

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
385 Previous Clinical Trials
629,017 Total Patients Enrolled
University of Missouri, Kansas CityOTHER
72 Previous Clinical Trials
34,424 Total Patients Enrolled
Affinia HealthcareUNKNOWN
~100 spots leftby Jan 2027