Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2023-05-25
2025-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Remote NST
Invu monitoring belt
INVU monitoring belt used for remote NSTs
In-clinic NST - Standard of Care
Standard of care
In-clinic NSTs - standard of care
Interventions
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Invu monitoring belt
INVU monitoring belt used for remote NSTs
Standard of care
In-clinic NSTs - standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Samuel Parry, MD
Professor of OBGYN
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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852291
Identifier Type: -
Identifier Source: org_study_id
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