Clinical trial NCT05847790: Remote Pregnancy Monitoring to Improve Access
Official title: Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fetal Monitoring
Keywords: Fetal monitoring
antenatal testing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-08
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Fetal Testing Completion Rate
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Testing Completion Rate in Black versus non-Black subjects
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
Secondary outcomes:
measure: Fetal Monitoring outcomes: Number of visits to the antenatal testing unit
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Time on NST monitor
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Number of non-reactive NSTs
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Number of biophysical profiles performed for non-reactive NST tests
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit directly related to a fetal monitoring visit
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Frequency of recommendation for delivery based on findings on fetal monitoring result
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Fetal Monitoring outcomes: Number of times a NST is not completed within the prescribed window
timeFrame: from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.
measure: Obstetrics outcomes: Gestational age at delivery
timeFrame: time of delivery
measure: Obstetrics outcomes: Number of participants with Preterm delivery
timeFrame: time of delivery
measure: Obstetrics outcomes: Mode of delivery
timeFrame: time of delivery
measure: Obstetrics outcomes: Number of participants with an Indication for labor induction
timeFrame: time of labor induction
measure: Obstetrics outcomes: Number of participants with an Indication for cesarean section
timeFrame: time of delivery
measure: Obstetrics outcomes: Composite neonatal morbidity score
timeFrame: from delivery to 6 weeks post-delivery
measure: Obstetrics outcomes: Neonatal cord blood pH
timeFrame: time of delivery
measure: Obstetrics outcomes: Apgar scores
timeFrame: five and ten minutes after delivery
measure: Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit
timeFrame: from delivery to 6 weeks post-delivery
measure: Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours
timeFrame: from delivery to 6 weeks post-delivery
measure: Obstetrics outcomes: Maternal length of stay
timeFrame: from delivery to discharge, up to 6 weeks post-delivery
measure: Obstetrics outcomes: Neonatal length of stay
timeFrame: from birth to discharge, up to 6 weeks after birth
measure: Cost-effectiveness outcomes: Productivity loss survey
timeFrame: 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)
measure: Cost-effectiveness outcomes: Costs
timeFrame: from 32 weeks to delivery, average of 10 weeks after enrollment.
measure: Implementation outcomes: Theory-informed Acceptability Questionnaire
timeFrame: at time of delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: