High Risk Pregnancy Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02627482 -
Ambulatory Fetal Heart Rate Monitoring in Small Babies
|
N/A | |
Active, not recruiting |
NCT03904979 -
Therapeutic Writing to Reduce Stress
|
N/A | |
Completed |
NCT02749851 -
Placenta Imaging Project
|
||
Completed |
NCT03772080 -
Prematurity Education in High Risk Pregnancies
|
N/A | |
Recruiting |
NCT06151613 -
Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies
|
N/A | |
Enrolling by invitation |
NCT05763069 -
HOME: Home Monitoring of High-risk Pregnancies
|
||
Completed |
NCT01708746 -
Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views
|
N/A | |
Not yet recruiting |
NCT04173559 -
Sleep and Tracking Effects in Pregnancy Study
|
N/A | |
Recruiting |
NCT03152058 -
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
|
Phase 2 | |
Not yet recruiting |
NCT06320054 -
Preventing Obstetric Complications With Dietary Intervention
|
N/A | |
Recruiting |
NCT03220750 -
University Hospital Advanced Age Pregnant Cohort
|
N/A | |
Not yet recruiting |
NCT04855513 -
Prevention of Pre-eclampsia Using Metformin: a Randomized Control Trial
|
N/A | |
Recruiting |
NCT06414655 -
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
|
||
Completed |
NCT03082664 -
Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients
|
N/A | |
Recruiting |
NCT06279559 -
Music Therapy and High-risk Pregnancy
|
N/A | |
Not yet recruiting |
NCT05479357 -
Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage
|
N/A | |
Recruiting |
NCT04203082 -
Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries
|
N/A | |
Recruiting |
NCT04783597 -
Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies
|
||
Recruiting |
NCT06130150 -
Sexual Function in High-risk Pregnant Women
|
||
Recruiting |
NCT03775954 -
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
|