Perinatal Care
Conditions
Brief 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.
Interventions
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
Sponsors
University of Michigan
PulseNmore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | One day | Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess preliminary effectiveness and compare participant results to standard of care BPP | One day | The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP |
| Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device. | One day | Patients will answer a questionnaire about their experience using Pulsenmore device |
Countries
United States
Outcome results
None listed