Remote fetal monitoring for high-risk pregnancies in Missouri

Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform

This study is testing if a new home monitoring system can help pregnant women with high-risk pregnancies feel more satisfied and save money compared to going to the clinic for regular check-ups.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Missouri-Columbia (other)
• Locations: 3 sites (Columbia, Missouri and 2 other locations)
• Trial ID: NCT06741735 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the use of the NUVO remote fetal monitoring system, allowing pregnant patients requiring weekly non-stress tests to conduct these tests from home. The study aims to assess patient and provider satisfaction, as well as cost savings associated with remote monitoring compared to traditional in-clinic testing. Participants will complete pre-implementation surveys and be randomly assigned to either the remote monitoring or in-clinic testing groups. The study also includes qualitative analyses through focus groups to understand barriers and predictors of use.

Who should consider this trial

Good fit: Ideal candidates are English-speaking pregnant individuals over 18 years old with singleton gestation requiring antenatal testing between 32-40 weeks and having Missouri Medicaid insurance.

Not a fit: Patients with multiple gestations or significant co-morbidities not listed in the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient satisfaction and reduce costs associated with fetal monitoring during high-risk pregnancies.

How similar studies have performed: Other studies have shown promise in using telehealth for remote monitoring, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Columbia, Missouri and 2 other locations

• University of Missouri — Columbia, Missouri, United States (RECRUITING)
• University of Missouri - Kansas City — Kansas City, Missouri, United States (NOT_YET_RECRUITING)
• Affinia Healthcare — St Louis, Missouri, United States (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Karen Florio, DO MPH

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