Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 1:16 PM
Study NCT ID:
NCT02379351
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: