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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
57 participants
OBSERVATIONAL
2023-02-09
2023-12-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pulsenmore ES Device, Efficacy and Safety Assessment
NCT05329077
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
NCT06859177
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring
NCT02379351
Safety and Performance of a Fetal Monitoring System
NCT05294211
Remote Telemedicine Fetal Monitoring Feasibility Study
NCT06366711
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Video guided
Participants will perform a scan using Pulsenmore ES device in the video mode independently following video tutorial. Participants will be remotely observed during the scan and interviewed by a human factoring researcher right after
Pulsenmore ES home ultrasound
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
Clinician guided
Participants will perform a scan using Pulsenmore ES device either in the clinician guided mode, guided by a health care professional via a telehealth visit. Participants and healthcare professionals will be remotely observed during the scan and interviewed by a human factoring researcher right after
Pulsenmore ES home ultrasound
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulsenmore ES home ultrasound
Fetal Ultrasound scanning using Pulsenmore ES device followed with an interview by a human factoring researched
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The participant has voluntarily provided authorization and signed the Videography and Photography Release form
* The participant is able to speak, read, write and comprehend US English and resides in the United States of America
* The participant to have adequate communications skills
* Pregnant women \> 18 years of age
* A singleton gestation
* Gestational age between 14 to 38 weeks with a prior scan demonstrating fetal viability and confirming dates
* Maximum BMI of 40
* Willing and able to participate in a 60-75 min video and is willing to be audio recorded for the post-procedure interview
* The HCP has voluntarily provided and signed the HCP consent information sheet (CIS)
* The HCP has voluntarily provided authorization and signed the HCP Videography and photography Release form
* The HCP is able to speak, read, write and comprehend US English and resides in the United States of America.
* The HCP has adequate communications skills
* The HCP is willing and able to participate in one 60 min video call and is willing to be audio recorded during the interview.
Exclusion Criteria
* Skin problem(s) in the abdominal area (such as wounds, cuts in the skin and skin rash)
* The participant has a visual or hearing impairment, and/or a condition that affects her motor and/or cognitive skills, that would prevent her from independently performing a fetal ultrasound scan at home
* The participant has a language barrier that can affect the communication and compliance to the usability study requirement
* Uncontrolled and untreated psychiatric conditions for a minimum of 6 months prior to screening,
* Alcohol or drug dependence with current symptoms
* Previous Pulsenmore ES trials and have previously used the Pulsenmore ES device
* Known fetal and genetic anomalies.
* The HCP has a visual or hearing impairment, that would prevent him or her from independently directing a fetal ultrasound scan
* The HCP has a language barrier and/or in the opinion of the recruiting interviewer provides any reason to believe that compliance with the study requirements will not be achievable
* The HCP has participated in in previous Pulsenmore trials and have previously used the Pulsenmore ES device
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PulseNmore
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan Dallabrida
Role: PRINCIPAL_INVESTIGATOR
SPRIM PRO
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Fetal Medicine and Women Ultrasound
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPRIM 22-1200
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.