Skip to main content
OpenTrials
Completed

NCT Number: NCT05847790

Remote Pregnancy Monitoring to Improve Access

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fetal Monitoring

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invu monitoring belt

Device

INVU monitoring belt used for remote NSTs

Standard of care

Other

In-clinic NSTs - standard of care

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. Obstetrics outcomes: Gestational age at delivery

    Time frame: time of delivery

    gestational age at time of delivery

  11. Obstetrics outcomes: Number of participants with Preterm delivery

    Time frame: time of delivery

    preterm delivery is defined as less than 37 weeks gestational age

  12. Obstetrics outcomes: Mode of delivery

    Time frame: time of delivery

    categorized as vaginal or cesarean

  13. 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

  14. 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

  15. 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

  16. Obstetrics outcomes: Neonatal cord blood pH

    Time frame: time of delivery

  17. 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.

  18. Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit

    Time frame: from delivery to 6 weeks post-delivery

  19. Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours

    Time frame: from delivery to 6 weeks post-delivery

  20. Obstetrics outcomes: Maternal length of stay

    Time frame: from delivery to discharge, up to 6 weeks post-delivery

  21. Obstetrics outcomes: Neonatal length of stay

    Time frame: from birth to discharge, up to 6 weeks after birth

  22. 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

  23. 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

  24. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial

Acronym: REACTIVE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.