NCT05329077

Brief Summary

This is a multicenter, prospective, investigational device study designed to evaluate: The safety, feasibility, and accuracy of the device, when used by pregnant individuals

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2023

Completed
Last Updated

November 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

March 20, 2022

Last Update Submit

November 28, 2023

Conditions

Perinatal Care

Outcome Measures

Primary Outcomes (2)

  • Comparison of device derived presence or absence of fetal cardiac activity to ground truth

    The presence or absence of device derived fetal cardiac activity would be matched with the presence or absence of fetal cardiac activity derived by the ground truth (in-clinic ultrasound scan)

    Test to be conducted during week 14-38 of pregnancy

  • Comparison of device derived amniotic fluid level status, normal or abnormal, to ground truth

    Comparison of device derived amniotic fluid level status, normal or abnormal, (measured by maximal vertical pocket in cm) would be matched with amniotic fluid level status derived from the ground truth (in-clinic ultrasound scan)

    Test to be conducted during week 14-38 of pregnancy

Secondary Outcomes (4)

  • Ability to assess fetal presentation from device derived input will be compared to the ground truth

    Test to be conducted during week 14-38 of pregnancy

  • Ability to assess placental location from device derived input will be compared to the ground truth

    Test to be conducted during week 14-38 of pregnancy

  • Ability to detect fetal movement from device derived input will be compared to the ground truth

    Test to be conducted during week 14-38 of pregnancy

  • Ability to detect fetal breathing from device derived input will be compared to the ground truth

    Test to be conducted during week >27-38 of pregnancy

Study Arms (1)

Home Ultrasound users

OTHER

Single Arm home ultrasound in pregnant women users

Device: Pulsenmore ES home ultrasound device

Interventions

Pulsenmore ES home ultrasound deviceDEVICE

Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters

Home Ultrasound users

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton gestation.
  • 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).

You may not qualify if:

  • Multiple gestations.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Fetal Medicine and Women's Ultrasound

Los Angeles, California, 90048, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32601-0294, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mount Sinai Hospital System

New York, New York, 10029, United States

Location

Related Publications (2)

  • Guidelines for Perinatal Care, 8th Edition, AAP and ACOG 2017. ISBN: 978-1-934984-69-7 (ACOG)

    BACKGROUND

  • 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.

    PMID: 26238329BACKGROUND

Study Officials

  • Reem Abu-Rustum, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 14, 2022

Study Start

April 14, 2022

Primary Completion

June 9, 2023

Study Completion

November 11, 2023

Last Updated

November 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)