Can a belt replace clinic visits for fetal monitoring?
NCT ID NCT05847790
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a remote monitoring belt (INVU) could help pregnant women complete fetal heart rate tests as effectively as going to the clinic. 400 women with singleton pregnancies between 30 and 35 weeks were randomly assigned to use the belt at home or receive standard in-clinic care. The goal was to see if remote monitoring improves test completion rates, especially among Black women.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Invu monitoring belt (device)
- What this could lead to
- If successful, this could show that remote monitoring is a practical alternative to in-clinic visits for some pregnant women, improving access and convenience.
- What could go wrong
- This is a completed trial with 400 participants, but results are not yet widely known. The device may not work as well for all groups, and remote monitoring might miss some issues that in-person checks catch.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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400 people
The number who actually took part.
- Started
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May 2023
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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