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Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

150 Participants Needed

Remote Fetal Monitoring for Pregnancy
(SHOW-ME Trial)

Recruiting at 2 trial locations

Overseen ByKaren 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the INVU fetal monitoring system treatment?

Research shows that remote fetal monitoring can improve adherence to monitoring sessions, especially in resource-limited settings, and may enhance safety by allowing for more timely responses to fetal health changes.¹ ² ³ ⁴ ⁵

Is remote fetal monitoring safe for use in pregnancy?

Research shows that remote fetal monitoring is generally safe and technically reliable, with safety comparable to traditional hospital monitoring. It has been used successfully in high-risk pregnancies without increasing perinatal mortality and can improve adherence to monitoring sessions.¹ ² ⁶ ⁷ ⁸

How does remote fetal monitoring differ from other treatments for pregnancy monitoring?

Remote fetal monitoring is unique because it allows pregnant women to monitor their baby's heart rate and well-being from home using wearable devices and telecommunication technology. This approach provides real-time feedback and reduces the need for frequent hospital visits, making it more convenient and potentially more cost-effective compared to traditional in-clinic monitoring methods.¹ ³ ⁴ ⁹ ¹⁰

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the potential benefit to patients and providers from using the remote fetal-monitoring system NUVO along with its app to allow for pregnant patients requiring weekly non-stress testing to do so from their homes. The main questions the investigators are looking to answer are:What effect does the NUVO remote fetal monitoring system have on patient/provider satisfaction?What is the cost savings (both direct and indirect) from using a remote fetal monitoring system as opposed to in-person testing for both the patient and the provider?Researchers will compare the survey responses by both patients and providers for pre and post implementation of the NUVO fetal monitoring system to the survey responses of patients and providers who used the traditional in-clinic method to evaluate satisfaction and cost savings.Participants will:Answer pre-implementation surveys before undergoing the trialBe randomly assigned to do either fetal testing at-home or in-clinic once or twice weekly as up to the providerBefore hospital discharge or within the last office visit participants will be given a post-implementation survey

Eligibility Criteria

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

See 5 more

Exclusion Criteria

Multiple gestations

Additional co-morbidities not listed in the inclusion criteria

PPROM or evidence of preterm labor

See 9 more

Timeline

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

Treatment Details

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.

Participant Groups

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 Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of Missouri, Kansas City

Collaborator

Trials

Recruited

34,600+

Affinia Healthcare

Collaborator

Trials

Recruited

150+

Findings from Research

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]

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]