Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
NCT ID: NCT06442358
Last Updated: 2025-06-24
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
25 participants
INTERVENTIONAL
2024-04-10
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single Arm home ultrasound in pregnant women require BPP
Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician
Pulsenmore ES home ultrasound device
Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider
Interventions
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Pulsenmore ES home ultrasound device
Pulsenmore ES device is a portable home used ultrasound device which allow the patient to perform an ultrasound scan from the comfort of their home under the supervision of a healthcare provider
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Gestational age ≥ 24 0/7 weeks
* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
* Ability to understand and sign informed consent in English
* Ability to read and understand instructions in English
* Ability to hold an ultrasound probe and respond to clinician instructions
* BMI less than 40 at initial prenatal visit
* Scheduled biophysical profile (BPP)
* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.
Exclusion Criteria
* Known major fetal structural anomaly or aneuploidy
* Known fetal or genetic anomalies
* Ruptured membranes
* Uterine complaints, such as painful contractions
* Maternal concern for decreased fetal movement
* Not evaluated vaginal bleeding (not including spotting)
* Fetal or maternal criteria that require urgent delivery
* BMI ≥ 40 at initial prenatal visit
18 Years
FEMALE
No
Sponsors
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University of Michigan
OTHER
PulseNmore
INDUSTRY
Responsible Party
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Principal Investigators
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Alex Peahl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00244136
Identifier Type: -
Identifier Source: org_study_id
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