Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Recruiting now · Not applicable
Conditions studied: Pregnancy
In brief
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
Key facts
- Study ID
- NCT06741735
- Run by
- University of Missouri-Columbia
- People needed
- 150
- Starts
- 2024-12-19
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-04-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- University of Missouri — Columbia, Missouri, United States (enrolling)
- University of Missouri - Kansas City — Kansas City, Missouri, United States
- Affinia Healthcare — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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