Remote Pregnancy Monitoring to Improve Access

Study Overview
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Brief Summary
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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.

Official Title
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Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial

Conditions
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Fetal Monitoring

Intervention / Treatment
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* Device: Invu monitoring belt
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Gestational age between 30 weeks 0 days and 35 weeks 6 days Pregnant patients who have clinical indication for fetal surveillance with NSTs (based on UPHS Health System clinical guidelines for antenatal monitoring) Able to provide written consent English speaking Exclusion Criteria: Multiple gestations Maternal pre-gravid BMI greater than 45kg/m2 Presence of an implanted pacemaker or defibrillator Active abdominal skin infection A known amniotic fluid index (AFI) less than 5cm or greater than 25cm on the most recent ultrasound (if available) prior to randomization Delivery is planned within 2 weeks of potential randomization
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote NST<br> | Device: Invu monitoring belt<br>* INVU monitoring belt used for remote NSTs<br>|
| Active Comparator: In-clinic NST - Standard of Care<br> | Other: Standard of care<br>* In-clinic NSTs - standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Fetal Testing Completion Rate | percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed | 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. | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Monitoring outcomes: Number of visits to the antenatal testing unit | Count of visits to the office for in-person monitoring | 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). | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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 of delivery | 
| Obstetrics outcomes: Number of participants with Preterm delivery | preterm delivery is defined as less than 37 weeks gestational age | time of delivery | 
| Obstetrics outcomes: Mode of delivery | categorized as vaginal or cesarean | 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 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 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 | from delivery to 6 weeks post-delivery | 
| Obstetrics outcomes: Neonatal cord blood pH |  | 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. | five and ten minutes after delivery | 
| Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit |  | from delivery to 6 weeks post-delivery | 
| Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours |  | from delivery to 6 weeks post-delivery | 
| Obstetrics outcomes: Maternal length of stay |  | from delivery to discharge, up to 6 weeks post-delivery | 
| Obstetrics outcomes: Neonatal length of stay |  | 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 | 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 | 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. | at time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal monitoring, antenatal testing