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Clinical Trials/NCT05847790
NCT05847790CompletedNot Applicable

Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial

University of Pennsylvania2 sites in 1 country400 target enrollmentStarted: May 25, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
2
Primary Endpoint
Overall Fetal Testing Completion Rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Remote NST

Experimental

Intervention: Invu monitoring belt (Device)

In-clinic NST - Standard of Care

Active Comparator

Intervention: Standard of care (Other)

Outcomes

Primary Outcomes

Overall Fetal Testing Completion Rate

Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed

Fetal Testing Completion Rate in Black versus non-Black subjects

Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

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.

Secondary Outcomes

  • Obstetrics outcomes: Neonatal cord blood pH(time of delivery)
  • Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring(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(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Obstetrics outcomes: Mode of delivery(time of delivery)
  • Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit(from delivery to 6 weeks post-delivery)
  • Cost-effectiveness outcomes: Productivity loss survey(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))
  • Fetal Monitoring outcomes: Number of visits to the antenatal testing unit(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Fetal Monitoring outcomes: Number of non-reactive NSTs(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Obstetrics outcomes: Gestational age at delivery(time of delivery)
  • Obstetrics outcomes: Number of participants with Preterm delivery(time of delivery)
  • Obstetrics outcomes: Number of participants with an Indication for labor induction(time of labor induction)
  • Obstetrics outcomes: Composite neonatal morbidity score(from delivery to 6 weeks post-delivery)
  • Obstetrics outcomes: Apgar scores(five and ten minutes after 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)
  • Fetal Monitoring outcomes: Number of biophysical profiles performed for non-reactive NST tests(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(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Obstetrics outcomes: Number of participants with an Indication for cesarean section(time of delivery)
  • Fetal Monitoring outcomes: Time on NST monitor(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(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
  • Obstetrics outcomes: Neonatal length of stay(from birth to discharge, up to 6 weeks after birth)
  • Cost-effectiveness outcomes: Costs(from 32 weeks to delivery, average of 10 weeks after enrollment.)
  • Implementation outcomes: Theory-informed Acceptability Questionnaire(at time of delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Samuel Parry, MD

Professor of OBGYN

University of Pennsylvania

Study Sites (2)

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