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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fetal Testing Completion Rate in Black versus non-Black subjects
Overall Fetal Testing Completion Rate
Secondary study objectives
Cost-effectiveness outcomes: Costs
Cost-effectiveness outcomes: Productivity loss survey
Fetal Monitoring outcomes: Frequency of provider recommended prolonged monitoring
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,081 Previous Clinical Trials
42,724,420 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,056 Previous Clinical Trials
2,737,744 Total Patients Enrolled

Media Library

Remote Pregnancy Monitoring Clinical Trial Eligibility Overview. Trial Name: NCT05847790 — N/A
Fetal Monitoring Research Study Groups: Remote NST, In-clinic NST - Standard of Care
Fetal Monitoring Clinical Trial 2023: Remote Pregnancy Monitoring Highlights & Side Effects. Trial Name: NCT05847790 — N/A
Remote Pregnancy Monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT05847790 — N/A
~87 spots leftby May 2025
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