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Completed

NCT Number: NCT06442358

Self Biophysical Profile Using a Home Ultrasound Device 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.

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Key information

Conditions

Perinatal Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsenmore ES home ultrasound device

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

Primary outcomes

  1. 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

    Time frame: One day

    Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level

Secondary outcomes

  1. Assess preliminary effectiveness and compare participant results to standard of care BPP

    Time frame: One day

    The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP

  2. Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.

    Time frame: One day

    Patients will answer a questionnaire about their experience using Pulsenmore device

Sponsors and collaborators

Lead sponsor

PulseNmore

Industry

Collaborators

  • University of Michigan

Registry information

Official study title

BPP for ME: Self Biophysical Profile Proof of Concept

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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