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 range18 Years

SexFEMALE

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

What they're measuring

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

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

Trial details

NCT IDNCT02379351

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2019-03-28