N/A
N=35
Refinement of the OBMedical LaborView System
Fetal Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT03244865 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study — 5.282 beats per minute — p=<.1
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- LaborView Electronic Fetal Monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- OBMedical Company
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study |
5.282 | <.1 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Admitted to Labor and Delivery at Shands UF Health
- Are able to consent for themselves
Exclusion Criteria
- Under the age of 18
Data sourced from ClinicalTrials.gov (NCT03244865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.