Trial Outcomes & Findings for Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring (NCT NCT02379351)

NCT ID: NCT02379351

Last Updated: 2025-03-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2025-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: In-Home Non-Stress Test Device 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.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-Home Non-Stress Test Device n=60 Participants Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital. Participants utilized the device on a weekly basis (at home) until the time of delivery. Participants also received an in clinic NST once a week. In-Home Non-Stress Test Device: Airstrip® Sense4Baby™
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

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

Population: Patients with physician-ordered twice-weekly NSTs scheduled in the OB Diagnostic Center at University of Utah Hospital. Participants were trained by clinicians at the hospital and then used the device on a weekly basis (at home) until the time of delivery. Participants will also receive an in clinic NST once a week.

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

Outcome measures

Outcome measures
Measure	Experimental: In-Home Non-Stress Test Device n=108 Remote NST's Completed 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.
Number of Interpretable Results (Participants Who Used the NST Device Correctly) Number of Interpretable Results	107 Remote NST's Completed
Number of Interpretable Results (Participants Who Used the NST Device Correctly) Number of Non-Interpretable Results	1 Remote NST's Completed

SECONDARY outcome

Timeframe: 2 Years

Population: Referring and NST Reading Providers

Provider Satisfaction With Remote NST Compared to On-site NST

Outcome measures

Outcome measures
Measure	Experimental: In-Home Non-Stress Test Device n=21 Participants 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.
Provider Satisfaction With Remote NST Compared to On-site NST	21 Participants

Adverse Events

Experimental: In-Home Non-Stress Test Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Clark

University of Utah, Department of Obstetrics & Gynecology

Phone: 801-5818425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place