Study of Remote Fetal Monitoring in Pregnancy (The SHOW-ME Study)

This study is looking at how well a remote fetal monitoring system, called INVU, works for pregnant individuals who need weekly non-stress tests (a common test to check on your baby's health). Instead of going to a clinic, you would use the INVU system at home with its app. Researchers want to understand if using INVU improves satisfaction for both patients and healthcare providers, and if it saves money compared to in-person testing. You may be able to join if you are over 18, speak English, are pregnant with one baby, and need antenatal testing between 32 and 40 weeks of pregnancy, with certain medical conditions like gestational diabetes. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 150 women. It will evaluate the implementation of a remote fetal-monitoring system.
What's involved
You will be recruited at any time during pregnancy if you meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation. You will use the INVU fetal monitoring system at home.
Compensation
If you have Missouri Medicaid, your expenses will be covered by the study. If you have private insurance or are self-pay, you will need to pay all expenses out of pocket.
Follow-up
The primary endpoint is measured at the time participants are recruited during pregnancy if they require antenatal fetal testing between 32 and 40 weeks gestation.

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NCT06741735

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

Recruiting
NAAges 18+Interventional
University of Missouri-Columbia
~150 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:INVU fetal monitoring system

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest framework
Measured over 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
Pregnancy
3 sites across 1 states
Missouri3

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Eligibility criteria

Inclusion

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)
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

Exclusion

Multiple gestations
  • Evaluate the implementation of a remote fetal-monitoring system through RE-AIM quest frameworkParticipants will be recruited at any time during pregnancy if they meet inclusion criteria and require antenatal fetal testing between 32 and 40 weeks gestation

    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