Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT06741735

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INVU fetal monitoring system

Study Details

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

Study ID

NCT06741735

Start date

Dec 19, 2024

Status verified date

Mar, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: At-home fetal monitoring

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.

no intervention: In-office fetal monitoring

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

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

Primary outcome measure

  • Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Karen Florio, DO MPH

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

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Karen Florio, DO MPH

573-817-3386obgynresearchsuccesscore@health.missouri.edu

Colin Paris, BS

573-817-3386cmpkdz@umsystem.edu

Principal Investigator:

Karen Florio, DO MPH

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Apr 3, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-04-03.