Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/12/2016 |
| Start Date: | July 2015 |
| End Date: | October 2017 |
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population
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.
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.
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.
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.
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
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-8425
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