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

NCT06741735 | Recruiting FDA Device

• 1 other identifier: 2097887
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Non-stress test; Home Fetal Monitoring; Telehealth; High-risk Pregnancy; Social determinants of health; Cost-effectiveness; NUVO

Outcome Measures

Primary Outcomes (1)

• Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework

  Each of the three participating centers and patients will receive access to and training in the INVU telehealth platform with the goal of studying the implementation (through pre and post implementation questionnaires) of this novel telehealth system and its impact on both patients and providers

  Participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation

Secondary Outcomes (1)

• Assess direct and indirect cost savings for patients, providers, and insurance carriers following implementation of a remote monitoring system

  Participants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation

Study Arms (2)

At-home fetal monitoring

EXPERIMENTAL

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.

Device: INVU fetal monitoring system

In-office fetal monitoring

NO 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.

Interventions

INVU fetal monitoring system DEVICE

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

At-home fetal monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Multiple gestations
• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of Missouri, Kansas City: collaborator
• Affinia Healthcare: collaborator

Study Sites (3)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

University of Missouri - Kansas City

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Affinia Healthcare

St Louis, Missouri, 63104, United States

NOT YET RECRUITING

Related Publications (6)

• Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.

  PMID: 30984733 BACKGROUND

• Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18.

  PMID: 23597377 BACKGROUND

• Arias MP, Wang E, Leitner K, Sannah T, Keegan M, Delferro J, Iluore C, Arimoro F, Streaty T, Hamm RF. The impact on postpartum care by telehealth: a retrospective cohort study. Am J Obstet Gynecol MFM. 2022 May;4(3):100611. doi: 10.1016/j.ajogmf.2022.100611. Epub 2022 Mar 22.

  PMID: 35331971 BACKGROUND

• Muppavarapu K, Saeed SA, Jones K, Hurd O, Haley V. Study of Impact of Telehealth Use on Clinic "No Show" Rates at an Academic Practice. Psychiatr Q. 2022 Jun;93(2):689-699. doi: 10.1007/s11126-022-09983-6. Epub 2022 Apr 12.

  PMID: 35412100 BACKGROUND

• Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available.

  PMID: 32439388 BACKGROUND

• Aziz A, Zork N, Aubey JJ, Baptiste CD, D'Alton ME, Emeruwa UN, Fuchs KM, Goffman D, Gyamfi-Bannerman C, Haythe JH, LaSala AP, Madden N, Miller EC, Miller RS, Monk C, Moroz L, Ona S, Ring LE, Sheen JJ, Spiegel ES, Simpson LL, Yates HS, Friedman AM. Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic. Am J Perinatol. 2020 Jun;37(8):800-808. doi: 10.1055/s-0040-1712121. Epub 2020 May 12.

  PMID: 32396948 BACKGROUND

Central Study Contacts

Karen Florio, DO MPH

CONTACT

(573) 817-6526; floriok@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician/Gynecologist (DO MPH)

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 19, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)