NCT05847790已完成不适用
Remote Pregnancy Monitoring to Improve Access: The REACTIVE Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Overall Fetal Testing Completion Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall Fetal Testing Completion Rate
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Obstetrics outcomes: Number of participants with an Indication for labor induction(time of labor induction)
- Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring(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(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
- Obstetrics outcomes: Mode of delivery(time of delivery)
- Obstetrics outcomes: Number of participants with an Admission to the neonatal intensive care unit(from delivery to 6 weeks post-delivery)
- 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))
- Fetal Monitoring outcomes: Number of visits to the antenatal testing unit(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
- Fetal Monitoring outcomes: Number of non-reactive NSTs(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
- Obstetrics outcomes: Gestational age at delivery(time of delivery)
- Obstetrics outcomes: Number of participants with Preterm delivery(time of delivery)
- Obstetrics outcomes: Composite neonatal morbidity score(from delivery to 6 weeks post-delivery)
- Obstetrics outcomes: Neonatal cord blood pH(time of delivery)
- Obstetrics outcomes: Apgar scores(five and ten minutes after 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)
- 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.)
- 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.)
- Obstetrics outcomes: Number of participants with an Indication for cesarean section(time of delivery)
- Fetal Monitoring outcomes: Time on NST monitor(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(from 32 weeks gestational age to delivery, average of 10 weeks after enrollment.)
- Obstetrics outcomes: Neonatal length of stay(from birth to discharge, up to 6 weeks after birth)
- Cost-effectiveness outcomes: Costs(from 32 weeks to delivery, average of 10 weeks after enrollment.)
- Implementation outcomes: Theory-informed Acceptability Questionnaire(at time of delivery)
研究者
Samuel Parry, MD
Professor of OBGYN
University of Pennsylvania
研究点 (2)
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