Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring

High Risk Pregnancy Clinical Trial

Official title:

Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379351
• Other study ID #: 77591
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: May 17, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Risk Pregnancy

Intervention

Device:
• In-Home Non-Stress Test Device
Airstrip® Sense4Baby™

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integration of Airstrip ® Sense4Baby™ remote non-stress test monitoring into health care system	Successful 'integration' will be defined by the ability to schedule remote non-stress tests, mid-level provider visualization and interpretation, communication of conclusion and recommendations to patients, physician visualization and interpretation, and clinical billing.	2 Years
Secondary	Frequency of uninterpretable and/or abnormal NSTs requiring on-site follow-up		2 Years
Secondary	Patient and provider satisfaction with remote NST compared to on-site NST (questionnaire)		2 Years
Secondary	Cost-effectiveness analysis for the health system and for patients		2 Years