Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

PulseNmore

Status: Completed

Conditions: Perinatal Care

Treatments: Device: Pulsenmore ES home ultrasound device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06442358

HUM00244136

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Single Arm home ultrasound in pregnant women require BPP

Other group

Description:

Pregnant participants will use Pulsenmore ES device to perform BPP while guided remotely by a clinician

Treatment:

Device: Pulsenmore ES home ultrasound device