Perinatal Care Clinical Trial
Official title:
BPP for ME: Self Biophysical Profile Proof of Concept
Verified date | May 2024 |
Source | PulseNmore |
Contact | Sarah Dwyer |
Phone | 734-647-7484 |
dwyersar[@]med.umich.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | September 11, 2024 |
Est. primary completion date | September 9, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
PulseNmore | University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessment will done by determining fetal movement, fetal tone, fetal breathing, and amniotic fluid level | One day | |
Secondary | Assess preliminary effectiveness and compare participant results to standard of care BPP | The results of BPP acquired with Pulsenmore device will be compared to standard of care BPP | One day | |
Secondary | Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device. | Patients will answer a questionnaire about their experience using Pulsenmore device | One day |
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