Clinical trial NCT02379351: Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
Official title: Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Pregnancy
Keywords: Non-stress Test
Fetal Monitoring
Telemedicine
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These tests are currently conducted in clinics and hospitals. This requires travel to a clinic or hospital, sometimes multiple times per week, in order to receive these tests. Technology has been developed that now allows for NSTs to be done in other locations, including home or work. The Airstrip® Sense4Baby™ NST device has been FDA-approved for use by obstetricians in clinical and hospital settings. The investigators are evaluating the use of the Airstrip® Sense4Baby™ NST device in out-of-hospital settings. The investigators would like to know if this type of monitoring is feasible and acceptable to patients and physicians.

Detailed description: Phase I of this study enrolls pregnant women with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at the University of Utah Hospital. Participants receive an in-clinic NST with the Airstrip® Sense4Baby™ device, are taught how to use the device, and asked to demonstrate their ability to use the device. Once the participant successfully demonstrates use of the monitor the device is given to the participant to use at the scheduled time each week. Patients receive educational materials, including a visuals-enhanced, short quick start guide.

For her remote NST monitoring, the patient will receive a virtual NST appointment. At the time of the scheduled appointment, the patient will apply the monitor and the NST will be read by the mid-level provider staffing the testing center after a thirty-minute strip has been recorded and transmitted to the database. The NST will also be interpreted by the maternal-fetal medicine physician, according to the established workflow. The patient will be notified of the result by a telephone call from the mid-level provider and appropriate follow-up arranged according to the NST management algorithm developed for this study. If the patient has trouble with using the device at home, the patient will be able to talk with the mid-level provider via telephone to troubleshoot issues.

The patient will also continue to receive an NST in clinic weekly. These NST schedules will be repeated on a weekly basis until delivery or until the provider discontinues the NST order.

Patients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.

Phase II of this study will enroll the same patient population (pregnant women with physician-ordered twice-weekly NSTs scheduled). Participants in Phase II may receive NSTs up to twice weekly at home. During regularly scheduled obstetric visits (every 1 to 2 weeks depending on gestational age and circumstances), NSTs will be performed on site. However, we will remove the requirement for once weekly on-site testing at the University of Utah Hospital.

The requirement to be within a 60-mile radius of University Hospital will be removed for Phase II participants. Instead, the requirement will be to be within a 60-mile radius of a hospital with an obstetric unit.

Patients will be contacted after delivery to assess overall satisfaction with the NST at home versus in clinic.

Eligibility criteria: Target population: The target population is high-risk pregnant women.

Accessible population: The accessible population is high-risk obstetric patients receiving care throughout the University of Utah Healthcare system and who receive their NSTs at MFDC.

Inclusion Criteria (Phase I):

* Singleton gestation
* Estimated gestational age of 32 0/7 -37 6/7 weeks
* Physician order for twice weekly NSTs
* Live within 60-mile radius of the University of Utah University Hospital
* Reliable access to and connectivity with wireless Internet
* Reliable for communication and follow-up

Exclusion Criteria (Phase I:

* Multifetal gestation
* Maternal age less than 18
* Plans to move prior to end of pregnancy
* No or limited access to internet and/or phone

Inclusion Criteria (Phase II):

* Singleton gestation
* Estimated gestational age of 32 0/7 -37 6/7 weeks
* Physician order for twice weekly NSTs
* Live within 60-mile radius of the University of Utah University Hospital or a hospital with an obstetric inpatient unit
* Reliable access to and connectivity with wireless Internet
* Reliable for communication and follow-up

Exclusion Criteria (Phase II):

* Multifetal gestation
* Maternal age less than 18
* Plans to move prior to end of pregnancy
* No or limited access to internet and/or phone

Primary outcomes:
measure: Number of Interpretable Results (Participants Who Used the NST Device Correctly)
timeFrame: Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery
Secondary outcomes:
measure: Provider Satisfaction With Remote NST Compared to On-site NST
timeFrame: 2 Years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Erin AS Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
References: