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Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)

NCT06741735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-03

No results posted yet for this study

Summary

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 trial

Be randomly assigned to do either fetal testing at-home or in-clinic once or twice weekly as up to the provider

Before hospital discharge or within the last office visit participants will be given a post-implementation survey

Conditions

  • Pregnancy

Interventions

DEVICE

INVU fetal monitoring system

INVU fetal monitoring system allows for at-home non-stress testing as opposed to the typical in-clinic testing

Sponsors & Collaborators

  • University of Missouri, Kansas City

    collaborator OTHER

  • Affinia Healthcare

    collaborator UNKNOWN

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2027-01-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741735 on ClinicalTrials.gov