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Remote Pregnancy Monitoring vs In-Clinic NST for Fetal Monitoring (REACTIVE Trial)
N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five and ten minutes after delivery
Awards & highlights
REACTIVE Trial Summary
This trial will compare two methods of fetal testing: in-clinic NSTs and remote monitoring belts, to see which one is more effective at improving completion rates.
Who is the study for?
This trial is for English-speaking pregnant individuals with a single baby, between 30 and 35 weeks along, who need fetal monitoring based on specific health guidelines. It's not for those with multiple babies, BMI over 45 before pregnancy, pacemakers or defibrillators, skin infections near the belly, abnormal amniotic fluid levels or if they plan to give birth within two weeks.Check my eligibility
What is being tested?
The study compares remote nonstress tests (NST) using an FDA-approved Invu monitoring belt to standard in-clinic NSTs for checking baby's health. Participants will be randomly assigned to one of these two methods to see which is more effective at ensuring tests are completed.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring techniques rather than medication or surgery, side effects are minimal but may include discomfort from wearing the belt or potential anxiety from remote testing.
REACTIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fetal Testing Completion Rate in Black versus non-Black subjects
Overall Fetal Testing Completion Rate
Secondary outcome measures
Cost-effectiveness outcomes: Costs
Cost-effectiveness outcomes: Productivity loss survey
Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring
+21 moreREACTIVE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Remote NSTExperimental Treatment1 Intervention
Group II: In-clinic NST - Standard of CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,637 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,966 Previous Clinical Trials
2,672,437 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI before pregnancy was over 45.I have a current skin infection on my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Remote NST
- Group 2: In-clinic NST - Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted into this investigation?
"At present, this clinical trial is inactive and not recruiting. According to the information posted on clinicaltrials.gov, it was first listed on May 1st 2023 before being updated for the last time in April 27th of the same year. In contrast, there are 3 other studies actively searching for participants right now."
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