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

Study acronym: SHOW-ME
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 27% 150 → 110 participants
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Record History

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  1. Minor Enrollment reduced: 150 → 110 participants Show 7 more changesShow less
    • Study completion pushed from Jul 2027 to Dec 2027
    • Study sites: 3 to 2
    • Primary completion date: Jan 2027 to Dec 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators: 2 to 1
    • Publications: details revised at 6 of 6 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Dec 19, 2024
    • Site details revised at 3 of 3 sites
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06741735
Lead Sponsor University of Missouri-Columbia
Collaborators: University of Missouri, Kansas City
Conditions
(from sponsor)
Pregnancy
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov