High Risk PregnancyNCT02379351
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
A study testing In-Home Non-Stress Test Device in people with High Risk Pregnancy, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- In-Home Non-Stress Test Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Multifetal gestation
- Maternal age less than 18
- Plans to move prior to end of pregnancy
- No or limited access to internet and/or phone
- Multifetal gestation
- Maternal age less than 18
- Plans to move prior to end of pregnancy
- No or limited access to internet and/or phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- High Risk Pregnancy
- Being tested
- In-Home Non-Stress Test Device
- Keywords
- Non-stress Test, Fetal Monitoring, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Home Non-Stress Test DeviceDevice
Airstrip® Sense4Baby™
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: In-Home Non-Stress Test Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Interpretable Results (Participants Who Used the NST Device Correctly)
Number of Interpretable Results (Participants who Used the NST Device Correctly)
Measured: 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
Provider Satisfaction With Remote NST Compared to On-site NST
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin AS Clark, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379351
- Sponsor's protocol ID
- 77591
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2015
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring In A Local High-Risk Obstetric Population
- ClinicalTrials.gov ID
- NCT02379351
- Acronym / sponsor ID
- 77591
- Conditions
- High Risk Pregnancy
- Keywords
- Non-stress Test, Fetal Monitoring, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-Home Non-Stress Test Device | Experimental | Device: In-Home Non-Stress Test DevicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- Multifetal gestation
- Maternal age less than 18
- Plans to move prior to end of pregnancy
- No or limited access to internet and/or phone
- Multifetal gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Home Non-Stress Test DeviceAirstrip® Sense4Baby™ | Device | In-Home Non-Stress Test Device |
Primary outcome
Number of Interpretable Results (Participants Who Used the NST Device Correctly)
Time frame: Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery
Number of Interpretable Results (Participants who Used the NST Device Correctly)
1 secondary outcome
Provider Satisfaction With Remote NST Compared to On-site NST
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin AS Clark, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Home Non-Stress Test Device in people with High Risk Pregnancy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Interpretable Results (Participants Who Used the NST Device Correctly) (time frame: Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.