Trials
Search / Trial NCT06442358

Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Launched by PULSENMORE · May 29, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether pregnant women can use a home ultrasound device to perform a Biophysical Profile (BPP) with help from a clinician over the phone or video call. A BPP is a test that checks on the health of the baby, and this study aims to see if women can safely and effectively do this at home instead of visiting a clinic.

To participate, women need to be at least 18 years old, pregnant with one baby (not twins or more), and at least 24 weeks along in their pregnancy. They should not have any major known birth defects in the baby and should be able to follow instructions in English. If you join the study, you'll receive guidance on how to use the ultrasound device and what to look for, making it easier to monitor your baby's health from home. This trial is currently recruiting participants, and it could provide valuable information about using technology to improve prenatal care.

Gender

FEMALE

Eligibility criteria

  • 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

Trial Officials

Alex Peahl, MD

Principal Investigator

University of Michigan

About Pulsenmore

Pulsenmore is a pioneering healthcare technology company dedicated to advancing remote patient monitoring and telemedicine solutions. Specializing in innovative diagnostic tools, Pulsenmore focuses on enhancing patient care by providing accessible and efficient monitoring of vital health parameters from the comfort of home. The company’s commitment to integrating cutting-edge technology with user-friendly interfaces empowers both healthcare professionals and patients, fostering improved clinical outcomes and streamlined healthcare delivery. Through its clinical trials, Pulsenmore aims to validate the efficacy of its products and contribute to the evolution of modern healthcare practices.

Locations

Ann Arbor, Michigan, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0