Using a home ultrasound device for antenatal testing
BPP for ME: Self Biophysical Profile Proof of Concept
This study is testing if pregnant women can use a home ultrasound device to check on their baby's health with some help from a doctor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | PulseNmore Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06442358 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether patients can perform a Biophysical Profile (BPP) at home using a self-administered ultrasound device with guidance from a clinician. Participants will be instructed on how to use the Pulsenmore ES home ultrasound device to assess fetal well-being remotely. The study focuses on singleton pregnancies at a gestational age of 24 weeks or more, allowing for a convenient and potentially safer method of monitoring during pregnancy. The goal is to determine the feasibility and effectiveness of this approach in perinatal care.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 18 and older with singleton pregnancies who are at least 24 weeks gestational age and have no major fetal anomalies.
Not a fit: Patients with multiple gestations or known major fetal structural anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more accessible and efficient way for expectant mothers to monitor fetal health from home.
How similar studies have performed: While the concept of remote monitoring in pregnancy is gaining traction, this specific approach using a home ultrasound device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Alex Peahl, MD — University of Michigan
- Study coordinator: Sarah Dwyer
- Email: dwyersar@med.umich.edu
- Phone: 734-647-7484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.