Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

BPP for ME: Self Biophysical Profile Proof of Concept

The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.

Study Overview

• Status: Completed
• Conditions: Perinatal Care
• Intervention / Treatment: Device: Pulsenmore ES home ultrasound device

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old
• 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:

• Multiple gestation
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being	Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess preliminary effectiveness and compare participant results to standard of care BPP	The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP	One day
Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.	Patients will answer a questionnaire about their experience using Pulsenmore device	One day

Collaborators and Investigators

• Sponsor: PulseNmore
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Alex Peahl, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HUM00244136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No