Monitoraggio remoto della gravidanza per migliorare l'accesso (REACTIVE)

INVU monitoring belt used for remote NSTs

In-clinic NSTs - standard of care

Percentage of recommended antenatal testing sessions successfully completed, defined as a clinically interpreted test performed. Calculated for each participant as: number of NST visits completed divided by number of NST visits expected × 100.

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. Calculated as the number of NST visits completed divided by the number of NST visits expected per participant × 100.

Count of visits to the office for in-person monitoring

For each participant, the percentage of all NST sessions requiring prolonged monitoring (>40 minutes) was calculated. The median participant-level percentage is reported.

Mean duration of NST monitoring sessions across all NSTs completed by each participant from randomization to delivery. Participant-level means were calculated and summarized by study arm.

Percentage of NSTs that were non-reactive among all NSTs completed for each participant.

Percentage of completed NSTs followed by biophysical profile assessment.

Number of Participants With ≥1 Obstetrical Triage Visit

Number of participants who underwent at least one obstetrical triage evaluation directly related to a fetal monitoring visit, during the study period from randomization until delivery.

Count of the number of subjects in each arm who receive a recommendation for delivery based on the findings of the fetal monitoring results.

Percentage 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.

gestational age at time of delivery

preterm delivery is defined as less than 37 weeks gestational age

categorized as vaginal or cesarean

in subjects who have labor induction, indication for inducing labor

in subjects who have a cesarean section delivery, indication for cesarean section

Number of participants whose neonate experienced at least one component of the composite neonatal morbidity outcome, defined as severe respiratory distress, neonatal resuscitation outside the delivery room, or neonatal death.

Apgar score at 1 and 5 minutes after delivery. Scores range from 0 to 10, with higher scores indicating better neonatal condition

Length of maternal hospitalization associated with the delivery admission, measured from hospital admission for delivery through maternal discharge.

Length of neonatal hospitalization from birth through hospital discharge.

Productivity loss was assessed by summing the number of days of work missed reported by participants across the two study productivity assessments. The reported value represents the total number of work days missed during the study period for each participant.

Total societal perspective cost per participant, calculated as the sum of direct healthcare costs, informal healthcare costs, and productivity costs incurred from randomization through delivery. Costs are reported in U.S. dollars (USD). The societal perspective includes costs related to antenatal testing, delivery hospitalization, neonatal care, triage visits, antepartum admissions, productivity losses, caregiving, and transportation.

Participant acceptability of the assigned fetal monitoring strategy was assessed using an 8-item Theory-Informed Acceptability Questionnaire (TFA). Total scores range from 8 to 40, with higher scores indicating greater acceptability of the monitoring approach.