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

NCT02379351 | Completed Results

• 1 other identifier: 77591
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Pregnancy

Keywords

Non-stress Test; Fetal Monitoring; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Number of Interpretable Results (Participants Who Used the NST Device Correctly)

  Number of Interpretable Results (Participants who Used the NST Device Correctly)

  Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery

Secondary Outcomes (1)

• Provider Satisfaction With Remote NST Compared to On-site NST

  2 Years

Study Arms (1)

In-Home Non-Stress Test Device

EXPERIMENTAL

Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital will be eligible for enrollment. After being taught how to use the Airstrip® Sense4Baby™ system machine, participants will use the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.

Device: In-Home Non-Stress Test Device

Interventions

In-Home Non-Stress Test Device DEVICE

Airstrip® Sense4Baby™

In-Home Non-Stress Test Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Results Point of Contact

• Title: Dr. Erin Clark
• Organization: University of Utah, Department of Obstetrics & Gynecology

erin.clark@hsc.utah.edu

801-5818425

Study Officials

• Erin AS Clark, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 4, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)