Remote Pregnancy Monitoring to Improve Access (REACTIVE)

Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Monitoring
• Intervention / Treatment: Device: Invu monitoring belt; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel Parry, MD; Phone Number: 215-662-4789; Email: parry@pennmedicine.upenn.edu
• Study Contact Backup: Name: Meaghan McCabe, MPH; Phone Number: 215-349-5277; Email: meaghan.mccabe@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Samuel Parry, MD
      • Contact: Meaghan McCabe, MPH; Phone Number: 215-349-5277; Email: meaghan.mccabe@pennmedicine.upenn.edu
      • Contact: Naeemah Turner, MSN; Phone Number: 215-275-2507; Email: naeemah.turner@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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: Mode of delivery	categorized as vaginal or cesarean	time of delivery
Obstetrics outcomes: Neonatal cord blood pH		time of 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
Obstetrics outcomes: Number of participants with Preterm delivery	preterm delivery is defined as less than 37 weeks gestational age	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: 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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Fetal monitoring; antenatal testing
• Other Study ID Numbers: 852291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No