Remote Fetal Monitoring for Pregnancy

(SHOW-ME Trial)

Recruiting at 3 trial locations

Overseen By Karen Florio, DO MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Multiple gestations, Preterm labor, Fetal complications, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new remote fetal monitoring system, NUVO (also known as the INVU fetal monitoring system), can make pregnancy check-ups more convenient and cost-effective. Researchers aim to determine if conducting fetal tests from home, rather than at a clinic, enhances satisfaction for both patients and healthcare providers. Participants will either use the NUVO system at home or continue with traditional in-clinic visits to compare experiences. Suitable candidates include pregnant individuals needing regular fetal tests, such as those with gestational diabetes or well-controlled chronic hypertension, who also have reliable internet access at home. As an unphased trial, this study offers the opportunity to contribute to innovative research that could transform prenatal care.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the NUVO remote fetal monitoring system is safe for at-home use?

Research has shown that the INVU fetal monitoring system is safe for use in people. It accurately measures the heart rates of both the baby and the mother without requiring any instruments inside the body, eliminating the need for invasive procedures. Studies have demonstrated that it usually provides clear and reliable results, indicating the device's effectiveness.

The FDA has approved the INVU system for monitoring heart rates during pregnancy, confirming it meets certain safety standards. To date, there have been no major reports of negative effects from using this device. Overall, the INVU system is well-accepted and trusted for remote monitoring during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INVU fetal monitoring system because it offers a convenient at-home alternative to traditional in-office visits. Unlike standard care, which requires expectant mothers to travel to clinics for monitoring, the INVU system allows non-stress testing to be conducted from the comfort of home. This approach leverages telehealth technology, making it easier for pregnant individuals to manage their health without the hassle of frequent clinic visits. Additionally, the system provides real-time data access, potentially enhancing communication between patients and healthcare providers. This trial could pave the way for more accessible prenatal care, reducing the need for in-person appointments while maintaining the quality of monitoring.

What evidence suggests that the NUVO remote fetal monitoring system is effective for pregnancy?

Research has shown that the INVU fetal monitoring system safely and easily checks both the baby's and mother's heart rates and monitors contractions. In this trial, participants in the at-home fetal monitoring arm will use the INVU system, which employs non-invasive technology, making it convenient for home use. Studies have found that this system can also automatically track blood pressure and body position. The FDA has approved INVU for monitoring heart rates and contractions, indicating its reliability for remote monitoring, offering benefits similar to traditional doctor visits. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Android or iOS system-operated telephone or tablet

Home or work access to reliable internet (WIFI screening completed by research personnel)

English Speaking

Exclusion Criteria

Multiple gestations

Additional co-morbidities not listed in the inclusion criteria

PPROM or evidence of preterm labor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Participants complete pre-implementation surveys and are randomized to either at-home or in-office fetal monitoring

1-2 weeks

1 visit (in-person or virtual)

Treatment

Participants undergo fetal monitoring either at home using the INVU system or in-office, once or twice weekly as determined by provider

8 weeks

8-16 visits (in-person or virtual)

Post-implementation

Participants complete post-implementation surveys before hospital discharge or at the last office visit

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INVU fetal monitoring system

Trial Overview

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.

How Is the Trial Designed?

Group I: At-home fetal monitoring Experimental Treatment 1 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 monitoring Active Control 1 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.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of Missouri, Kansas City

Collaborator

Trials

73

Recruited

34,600+

Affinia Healthcare

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

The study involved 204 high-risk pregnant women, with 97 using a long-distance electronic fetal heart rate monitoring system at home, which allowed them to monitor their baby's heart rate and contact a hospital if abnormalities were detected.

Using this monitoring system significantly reduced the incidence of neonatal asphyxia and improved perinatal care quality, despite a higher rate of abnormal non-stress tests and Apgar scores in the study group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of long-distance electronic fetal heart rate monitoring system by telephone]. Pan, J., Ye, M., Du, X.[2006]

The remote fetal monitoring network significantly increased the frequency of non-stress tests (NST) in high-risk pregnancies, leading to better monitoring without increasing costs.

This method resulted in lower rates of neonatal asphyxia (10.3% vs. 20.8%) and preterm birth (12.6% vs. 24.5%) compared to traditional monitoring, while not affecting the cesarean section rates, indicating its efficacy and safety in managing high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical value of remote fetal monitoring network in high-risk pregnancy]. Qi, H., Sun, J., Liu, J., et al.[2006]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8157941/

Comprehensive pregnancy monitoring with a network of ...

This system offers advanced features such as continuous blood pressure, uterine electrohysterography, and automated body position classification ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06741735

Study of Fetal Health Outcomes: Working With a Missouri E ...

INVU is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR).

3.

ajogmfm.org

ajogmfm.org/article/S2589-9333(20)30031-8/fulltext

Wireless, remote solution for home fetal and maternal heart ...

The Invu device uses passive technology to allow for safe, non-invasive and convenient monitoring of patients in the clinic and remotely. Further work should ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589933320300318

Wireless, remote solution for home fetal and maternal heart ...

The Invu device uses passive technology to allow for safe, non-invasive and convenient monitoring of patients in the clinic and remotely. Further work should ...

5.

nuvocares.com

nuvocares.com/solutions

Remote Fetal Monitoring | Innovative Care Solutions | INVU ...

INVU™ is cleared by the FDA for fetal heart rate, maternal heart rate, and uterine activity (contractions). INVU™ is HIPPA compliant and certified ISO 13485 and ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf21/K210025.pdf

May 28, 2021 Nuvo-Group Ltd. Janice M. Hogan Partner ...

INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and ...

7.

ajog.org

ajog.org/article/S0002-9378(23)00809-8/fulltext

Real-world benefits of the INVU remote fetal nonstress ...

A pattern of reliability and efficiency emerged, successfully obtaining an interpretable nonstress test (NST) in most appointments.

8.

carnegieimaging.com

carnegieimaging.com/blog/how-invu-by-nuvo-is-revolutionizing-prenatal-care-with-remote-pregnancy-monitoring/

How INVU by Nuvo is Revolutionizing Prenatal Care ...

The INVU sensor band is equipped with ECG and acoustic sensors to measure fetal and maternal heart rates, as well as uterine activity. After ...