Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2022-04-14
2023-11-11
Brief Summary
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The safety, feasibility, and accuracy of the device, when used by pregnant individuals
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Home Ultrasound users
Single Arm home ultrasound in pregnant women users
Pulsenmore ES home ultrasound device
Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters
Interventions
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Pulsenmore ES home ultrasound device
Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters
Eligibility Criteria
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Inclusion Criteria
* Gestational age \>14 weeks with a prior scan demonstrating fetal viability and confirming dates.
* English or Spanish speaking.
* Ability to understand and sign the informed consent (available in English and Spanish).
* Ability to read and understand instructions that are required for equipment use (instructions available in both languages).
Exclusion Criteria
* BMI \>40.
* Known fetal and genetic anomalies.
* Subjects with skin problems in the abdominal area (such as wounds, cuts in the skin, and skin rash).
* Subjects allergic to the ultrasound probe materials.
* Non-English/ non-Spanish speaking.
* Unable to provide consent.
18 Years
FEMALE
No
Sponsors
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PulseNmore
INDUSTRY
Responsible Party
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Principal Investigators
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Reem Abu-Rustum, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Center for Fetal Medicine and Women's Ultrasound
Los Angeles, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital System
New York, New York, United States
Countries
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References
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Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)
Abuhamad A, Zhao Y, Abuhamad S, Sinkovskaya E, Rao R, Kanaan C, Platt L. Standardized Six-Step Approach to the Performance of the Focused Basic Obstetric Ultrasound Examination. Am J Perinatol. 2016 Jan;33(1):90-8. doi: 10.1055/s-0035-1558828. Epub 2015 Aug 3.
Other Identifiers
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2201V1
Identifier Type: -
Identifier Source: org_study_id