Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Last updated: May 29, 2024
Sponsor: PulseNmore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Labor/delivery

Treatment

Pulsenmore ES home ultrasound device

Clinical Study ID

NCT06442358
HUM00244136
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 notlimited to intrauterine growth restriction, chronic or gestational hypertension,preexisting or gestational diabetes, autoimmune disorder, etc.

Exclusion

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

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Pulsenmore ES home ultrasound device
Phase:
Study Start date:
April 10, 2024
Estimated Completion Date:
September 11, 2024

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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