Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

Perinatal Care Clinical Trial

Official title:

BPP for ME: Self Biophysical Profile Proof of Concept

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442358
• Other study ID #: HUM00244136
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: September 11, 2024

Study information

• Verified date: May 2024
• Source: PulseNmore
• Contact: Sarah Dwyer
• Phone: 734-647-7484
• Email: dwyersar[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Perinatal Care

Intervention

Device:
• Pulsenmore ES home ultrasound device
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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
PulseNmore	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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