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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 weeks3 visits

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

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.

0 / 6Eligibility criteria met