Remote Pregnancy Monitoring to Improve Access (REACTIVE)

October 28, 2025 updated by: Samuel Parry, MD, University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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.
from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fetal Monitoring outcomes: Number of visits to the antenatal testing unit
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
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
Time Frame: time of delivery
gestational age at time of delivery
time of delivery
Obstetrics outcomes: Mode of delivery
Time Frame: time of delivery
categorized as vaginal or cesarean
time of delivery
Obstetrics outcomes: Neonatal cord blood pH
Time Frame: time of delivery
time of delivery
Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours
Time Frame: from delivery to 6 weeks post-delivery
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
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
from birth to discharge, up to 6 weeks after birth
Cost-effectiveness outcomes: Productivity loss survey
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)
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
Time Frame: from 32 weeks to delivery, average of 10 weeks after enrollment.
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
Time Frame: at time of delivery
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
Time Frame: time of 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
Time Frame: time of 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
Time Frame: time of delivery
in subjects who have a cesarean section delivery, indication for cesarean section
time of delivery
Obstetrics outcomes: Composite neonatal morbidity score
Time Frame: from delivery to 6 weeks post-delivery
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
Time Frame: five and ten minutes after delivery
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
Time Frame: from delivery to 6 weeks post-delivery
from delivery to 6 weeks post-delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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