An interventional study of Invu monitoring belt and Standard of care in Fetal Monitoring, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Diagnostic
The goal of this clinical trial is to determine the effectiveness of remote nonstress test (NST) compared to in-clinic NSTs in improving fetal testing completion rates. Participants will be randomized to either in-clinic NSTs or use of an FDA-approved remote monitoring belt for their pregnancy monitoring.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Invu monitoring belt
Other: Standard of care
INVU monitoring belt used for remote NSTs
In-clinic NSTs - standard of care
Overall Fetal Testing Completion Rate
percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Testing Completion Rate in Black versus non-Black subjects
Comparison between Black and non-Black subjects' percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed.
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Number of visits to the antenatal testing unit
Count of visits to the office for in-person monitoring
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring
Count of number of times provider recommends prolonged monitoring (defined by greater than 40 minutes of time on the monitor).
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Time on NST monitor
Sum of the number of minutes the subject is on the NST monitor
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Number of non-reactive NSTs
Count of the number of visits
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Number of biophysical profiles performed for non-reactive NST tests
Count of the number of biophysical profiles performed for non-reactive NST visits
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit
Count of the number of visits to the obstetrical triage unit
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit directly related to a fetal monitoring visit
Count of the number of visit directly related to an outpatient fetal monitoring appointment or session
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Frequency of recommendation for delivery based on findings on fetal monitoring result
Count of the number of subjects in each arm who receive a recommendation for delivery based on the findings of the fetal monitoring results.
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Fetal Monitoring outcomes: Number of times a NST is not completed within the prescribed window
Count of number of NSTs which occur outside of prescribed window, for example, if a weekly testing regimen is prescribed, an appointment 8 or more days following the last one would count as 1 missed calendar window.
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Obstetrics outcomes: Gestational age at delivery
gestational age at time of delivery
Time frame: time of delivery
Obstetrics outcomes: Number of participants with Preterm delivery
preterm delivery is defined as less than 37 weeks gestational age
Time frame: time of delivery
Obstetrics outcomes: Mode of delivery
categorized as vaginal or cesarean
Time frame: time of delivery
Obstetrics outcomes: Number of participants with an Indication for labor induction
in subjects who have labor induction, indication for inducing labor
Time frame: time of labor induction
Obstetrics outcomes: Number of participants with an Indication for cesarean section
in subjects who have a cesarean section delivery, indication for cesarean section
Time frame: time of delivery
Obstetrics outcomes: Composite neonatal morbidity score
Composite score of neonatal morbidity comprised of one or more of the following: severe respiratory distress, neonatal resuscitation outside of the delivery room, and death. This score could range from 0 to 3 with a higher score meaning a worse outcome
Time frame: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Neonatal cord blood pH
Time frame: time of delivery
Obstetrics outcomes: Apgar scores
Apgar score at five and ten minutes after delivery, the score ranges from 0 to 10 with a higher score meaning a better outcome.
Time frame: five and ten minutes after delivery
Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit
Time frame: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours
Time frame: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Maternal length of stay
Time frame: from delivery to discharge, up to 6 weeks post-delivery
Obstetrics outcomes: Neonatal length of stay
Time frame: from birth to discharge, up to 6 weeks after birth
Cost-effectiveness outcomes: Productivity loss survey
This survey will collect in half days increments the productivity impacts of the pregnancy, NSTs and for seeking health care for those reasons
Time frame: at three timepoints, at time of randomization, 3 weeks after randomization (plus or minus 1 week) and 5 weeks after randomization (plus or minus 1 week)
Cost-effectiveness outcomes: Costs
Costs will be estimated based on collection of data on all health care visits, including outpatient, ED, OB triage and hospital admissions
Time frame: from 32 weeks to delivery, average of 10 weeks after enrollment.
Implementation outcomes: Theory-informed Acceptability Questionnaire
8-item Likert scale with range of values from 8 to 40 with a high score being more acceptable.
Time frame: at time of delivery
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania