Remote fetal monitoring for high-risk pregnancies in Missouri

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Missouri
  Columbia, Missouri, United States Recruiting
• University of Missouri - Kansas City
  Kansas City, Missouri, United States Recruiting

Study contacts

• Study coordinator: Karen Florio, DO MPH
• Email: floriok@health.missouri.edu
• Phone: (573) 817-6526

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.