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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote NST | Experimental |
| |
| In-clinic NST - Standard of Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invu monitoring belt | Device | INVU monitoring belt used for remote NSTs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Fetal Testing Completion Rate | percentage of recommended antenatal testing sessions that were successfully completed as defined as a clinically interpreted test was performed | 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. | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Monitoring outcomes: Number of visits to the antenatal testing unit | Count of visits to the office for in-person monitoring | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. |
| Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
In-clinic NSTs - standard of care |
|
Count of number of times provider recommends prolonged monitoring (defined by greater than 40 minutes of time on the monitor). |
| 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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 | time of delivery |
| Obstetrics outcomes: Number of participants with Preterm delivery | preterm delivery is defined as less than 37 weeks gestational age | time of delivery |
| Obstetrics outcomes: Mode of delivery | categorized as vaginal or cesarean | time of delivery |
| Obstetrics outcomes: Number of participants with an Indication for labor induction | in subjects who have labor induction, indication for inducing labor | 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 | 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 | from delivery to 6 weeks post-delivery |
| Obstetrics outcomes: Neonatal cord blood pH | 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. | five and ten minutes after delivery |
| Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit | from delivery to 6 weeks post-delivery |
| Obstetrics outcomes: Admission to the neonatal intensive care unit for greater than 48 hours | from delivery to 6 weeks post-delivery |
| Obstetrics outcomes: Maternal length of stay | from delivery to discharge, up to 6 weeks post-delivery |
| Obstetrics outcomes: Neonatal length of stay | 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 | 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 | 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. | at time of delivery |