Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Description

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.

Conditions

Perinatal Care

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Study Overview

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Study Details

Study overview

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.

BPP for ME: Self Biophysical Profile Proof of Concept

Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Condition
Perinatal Care
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

PulseNmore,

Alex Peahl, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2024-09-11