Fetal Monitoring
Conditions
Keywords
Fetal monitoring, antenatal testing
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.
Interventions
DEVICEInvu monitoring belt
INVU monitoring belt used for remote NSTs
OTHERStandard of care
In-clinic NSTs - standard of care
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fetal Testing Completion Rate | 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 |
| Fetal Testing Completion Rate in Black versus non-Black subjects | 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
| Measure | Time frame | Description |
|---|---|---|
| Obstetrics outcomes: Mode of delivery | time of delivery | categorized as vaginal or cesarean |
| Fetal Monitoring outcomes: Number of visits to the antenatal testing unit | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. | Count of visits to the office for in-person monitoring |
| Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring | 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). |
| Fetal Monitoring outcomes: Time on NST monitor | 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 |
| Fetal Monitoring outcomes: Number of non-reactive NSTs | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. | Count of the number of visits |
| Fetal Monitoring outcomes: Number of biophysical profiles performed for non-reactive NST tests | 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 |
| Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit | from 32 weeks gestational age to delivery, average of 10 weeks after enrollment. | Count of the number of visits to the obstetrical triage unit |
| Fetal Monitoring outcomes: Overall number of visits to the obstetrical triage unit directly related to a fetal monitoring visit | 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 |
| Fetal Monitoring outcomes: Frequency of recommendation for delivery based on findings on fetal monitoring result | 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. |
| Fetal Monitoring outcomes: Number of times a NST is not completed within the prescribed window | 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. |
| Obstetrics outcomes: Number of participants with an Indication for labor induction | time of labor induction | in subjects who have labor induction, indication for inducing labor |
| Obstetrics outcomes: Gestational age at delivery | time of delivery | gestational age at time of delivery |
| Obstetrics outcomes: Composite neonatal morbidity score | 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 |
| Obstetrics outcomes: Neonatal cord blood pH | time of delivery | — |
| Obstetrics outcomes: Apgar scores | 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. |
| 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 | 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 |
| Cost-effectiveness outcomes: Costs | 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 |
| Implementation outcomes: Theory-informed Acceptability Questionnaire | at time of delivery | 8-item Likert scale with range of values from 8 to 40 with a high score being more acceptable. |
| Obstetrics outcomes: Number of participants with an Indication for cesarean section | time of delivery | in subjects who have a cesarean section delivery, indication for cesarean section |
| Obstetrics outcomes: Number of participants with Preterm delivery | time of delivery | preterm delivery is defined as less than 37 weeks gestational age |
Countries
United States
Outcome results
None listed