Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring (NCT02379351) | Clinical Trial Compass
CompletedNot Applicable
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
United States60 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Interpretable Results (Participants Who Used the NST Device Correctly)
Timeframe: Enrollment at 32 0/7 - 37 6/7 weeks gestation through delivery