Actively Recruiting
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Led by University of Missouri-Columbia · Updated on 2025-04-03
150
Participants Needed
3
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University of Missouri-Columbia
Lead Sponsor
U
University of Missouri, Kansas City
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- 18 years of age or older
- Pregnant with a singleton baby
- Primary insurance is Missouri Medicaid (covered by study) or private insurance with self-pay
- Requires antenatal fetal testing between 32 and 40 weeks gestation
- Has one or more of the following: gestational diabetes, well-controlled type II diabetes, chronic hypertension without placental insufficiency, advanced maternal age, or obesity (BMI over 30 and under 45)
- Owns an Android or iOS smartphone or tablet
- Has reliable internet (WIFI) access at home or work
You will not qualify if you...
- Pregnant with multiple babies (twins or more)
- Has additional health problems not listed in inclusion criteria
- Has preterm premature rupture of membranes (PPROM) or signs of preterm labor
- Has abnormal amniotic fluid levels (oligohydramnios less than 5 cm or polyhydramnios over 30 cm)
- Has fetal complications such as fetal growth restriction, placenta or vasa previa, fetal chromosomal or structural anomalies, or recent abnormal biophysical profile (BPP less than 8/10)
- Plans to change care provider during pregnancy
- Currently institutionalized or incarcerated
- Unable to consent for oneself
- Under 18 years of age
- History of prior stillbirth
- Does not have reliable internet access
- Has an abdominal skin disorder preventing use of the INVU device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
2
University of Missouri - Kansas City
Kansas City, Missouri, United States, 64111
Not Yet Recruiting
3
Affinia Healthcare
St Louis, Missouri, United States, 63104
Not Yet Recruiting
Research Team
K
Karen Florio, DO MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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