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

RecruitingNAAges 18 Years - anyFemaleUniversity of Missouri-Columbia
NCT06741735 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria * English Speaking * \> 18 years of age * Singleton gestation * Missouri Medicaid as primary insurance (paid by study), offered to patients with private insurance for self-pay * Requires antenatal testing between 32-40 weeks according to institutional policies * One of the following indications for fetal NST: * Gestational diabetes * Well-controlled type II diabetes * Chronic hypertension without evidence of placental insufficiency * Advanced maternal age * Obesity (as defined as BMI \>30 and \<45) * Android or iOS system-operated telephone or tablet * Home or work access to reliable internet (WIFI screening completed by research personnel) Exclusion Criteria * Multiple gestations * Additional co-morbidities not listed in the inclusion criteria * PPROM or evidence of preterm labor * Oligohydramnios of \< 5 cm of polyhydramnios \> 30 * Co-existing fetal complications: FGR, placenta or vasa previa, fetal chromosomal or structural anomaly, recent (within a week) fetal testing of a BPP \< 8/10 prior to enrollment * Intention to transfer care to different provider during the pregnancy * Currently institutionalized or incarcerated * Inability to consent for oneself * \<18 years of age * History of prior stillbirth * Lack of access to reliable internet * Abdominal skin disorder that prevents use of the INVO device
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What it tests

  • INVU fetal monitoring system
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Where

2 sites
University of Missouri
Columbia, United States
University of Missouri - Kansas City
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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