Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Not Applicable

Completed

• Conditions: Perinatal Care

• Registration Number: NCT06442358
• Lead Sponsor: PulseNmore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-10
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-04
• Primary Completion: 2024-09-09
• Study Completion: 2024-12-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	One day	Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States