アクセスを改善するためのリモート妊娠モニタリング (REACTIVE)

実験的：リモートNST

デバイス：Invu monitoring belt

INVU monitoring belt used for remote NSTs

アクティブコンパレータ：クリニックでのNST - 標準治療

他の：Standard of care

In-clinic NSTs - standard of care

Fetal Testing Completion Rate

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.

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

Fetal Monitoring Outcomes: Number of Visits to the Antenatal Testing Unit

Count of visits to the office for in-person monitoring

Fetal Monitoring Outcomes: Percentage of Non-Stress Test Sessions Requiring Provider-Recommended Prolonged Monitoring

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

Fetal Monitoring Outcomes: Average Duration of Non-Stress Test Monitoring Sessions

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.

Fetal Monitoring Outcomes: Non-reactive NST Rate

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

Fetal Monitoring Outcomes: Percentage of NSTs Resulting in Biophysical Profile Evaluation

Percentage of completed NSTs followed by biophysical profile assessment.

Fetal Monitoring Outcomes: Number of Participants With ≥1 Obstetrical Triage Visit

Number of Participants With ≥1 Obstetrical Triage Visit

Fetal Monitoring Outcomes: Number of Participants Who Had Any Triage Visit Directly Related to a Fetal Monitoring 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.

Fetal Monitoring Outcomes: Number of Participants Recommended 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.

Fetal Monitoring Outcomes: Percentage of NSTs Not Completed Within the Prescribed Window

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.

Obstetrics Outcomes: Gestational Age at Delivery

gestational age at time of delivery

Obstetrics Outcomes: Number of Participants With Preterm Delivery

preterm delivery is defined as less than 37 weeks gestational age

Obstetrics Outcomes: Mode of Delivery

categorized as vaginal or cesarean

Obstetrics Outcomes: Number of Participants With an Indication for Labor Induction

in subjects who have labor induction, indication for inducing labor

Obstetrics Outcomes: Number of Participants With an Indication for Cesarean Section

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

Obstetrics Outcomes: Number of Participants With Composite Neonatal Morbidity

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.

Obstetrics Outcomes: Neonatal Cord Blood pH

Obstetrics Outcomes: Apgar Scores

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

Obstetrics Outcomes: Number of Participants With an Admission to the Neonatal Intensive Care Unit

Obstetrics Outcomes: Number of Participants Who Had an Admission to the Neonatal Intensive Care Unit for Greater Than 48 Hours

Obstetrics Outcomes: Maternal Length of Hospital Stay

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

Obstetrics Outcomes: Neonatal Length of Hospital Stay

Length of neonatal hospitalization from birth through hospital discharge.

Cost-effectiveness Outcomes: Productivity Loss Due to Antenatal Testing and Monitoring

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.

Cost-effectiveness Outcomes: Total Societal Perspective Cost

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.

Implementation Outcomes: Theory-informed Acceptability Questionnaire

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.