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Completed No phase listed Observational Accepts healthy volunteers Results available

Refinement of the OBMedical LaborView System

ClinicalTrials.gov ID: NCT03244865

Public ClinicalTrials.gov record NCT03244865. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 1:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Refinement of LaborView Electronic Fetal Monitor

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have limitations (tracing loss during fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR and contraction information inform this study. LaborView®, developed by researchers at University of Florida (UF) College of Medicine and OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms continues, and that work is most effectively performed at UF, where the primary researchers and OBMedical are located. LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals will then be analyzed off-line for comparison and refinement of algorithms.

Study identification

NCT ID
NCT03244865
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
OBMedical Company
Other
Enrollment
35 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 28, 2016
Primary completion
Apr 10, 2018
Completion
Apr 10, 2018
Last update posted
Sep 19, 2019

2016 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Florida Shands Health Gainesville Florida 32608

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03244865, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 19, 2019 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03244865 live on ClinicalTrials.gov.

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