Fetal MonitoringREACTIVENCT05847790
Remote Pregnancy Monitoring to Improve Access
A study testing Invu monitoring belt in people with Fetal Monitoring, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- Invu monitoring belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Fetal Monitoring
- Being tested
- Invu monitoring belt, Standard of care
- Keywords
- Fetal monitoring, antenatal testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invu monitoring beltDevice
INVU monitoring belt used for remote NSTs
Standard of careOther
In-clinic NSTs - standard of care
| Study group | Role | What they receive |
|---|---|---|
| Remote NST | Experimental | Not described Receives: Device: Invu monitoring belt |
| In-clinic NST - Standard of Care | Active comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Fetal Testing Completion Rate
percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed
Measured: 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.
Measured: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Secondary outcomes (24)
Fetal Monitoring outcomes: Number of visits to the antenatal testing unit
Count of visits to the office for in-person monitoring
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: time of delivery
Obstetrics outcomes: Number of participants with Preterm delivery
preterm delivery is defined as less than 37 weeks gestational age
Measured: time of delivery
Obstetrics outcomes: Mode of delivery
categorized as vaginal or cesarean
Measured: time of delivery
Obstetrics outcomes: Number of participants with an Indication for labor induction
in subjects who have labor induction, indication for inducing labor
Measured: 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
Measured: 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
Measured: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Neonatal cord blood pH
Measured: 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.
Measured: five and ten minutes after delivery
Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit
Measured: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours
Measured: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Maternal length of stay
Measured: from delivery to discharge, up to 6 weeks post-delivery
Obstetrics outcomes: Neonatal length of stay
Measured: 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
Measured: 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
Measured: 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.
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start25 May 2023
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Samuel Parry, MD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847790
- Sponsor's protocol ID
- 852291
- Acronym
- REACTIVE
- Status last verified
- May 2025
- First submitted
- 27 Apr 2023
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial
- ClinicalTrials.gov ID
- NCT05847790
- Acronym / sponsor ID
- REACTIVE / 852291
- Conditions
- Fetal Monitoring
- Keywords
- Fetal monitoring, antenatal testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote NST | Experimental | Device: Invu monitoring belt |
| In-clinic NST - Standard of Care | Active comparator | Other: Standard of care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invu monitoring beltINVU monitoring belt used for remote NSTs | Device | Remote NST |
| Standard of careIn-clinic NSTs - standard of care | Other | In-clinic NST - Standard of Care |
Primary outcome
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.
24 secondary outcomes
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.
Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring
Time frame: 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.
Fetal Monitoring outcomes: Number of non-reactive NSTs
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
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
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
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
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
Time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Obstetrics outcomes: Gestational age at delivery
Time frame: time of delivery
Obstetrics outcomes: Number of participants with Preterm delivery
Time frame: time of delivery
Obstetrics outcomes: Mode of delivery
Time frame: time of delivery
Obstetrics outcomes: Number of participants with an Indication for labor induction
Time frame: time of labor induction
Obstetrics outcomes: Number of participants with an Indication for cesarean section
Time frame: time of delivery
Obstetrics outcomes: Composite neonatal morbidity score
Time frame: from delivery to 6 weeks post-delivery
Obstetrics outcomes: Neonatal cord blood pH
Time frame: time of delivery
Obstetrics outcomes: Apgar scores
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
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
Time frame: from 32 weeks to delivery, average of 10 weeks after enrollment.
Implementation outcomes: Theory-informed Acceptability Questionnaire
Time frame: at time of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invu monitoring belt in people with Fetal Monitoring, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Fetal Testing Completion Rate (time frame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.