50 Participants Needed

Holter Device for Fetal Monitoring

MF
AG
Overseen ByAmy Gest, MPA
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Holter Device for fetal monitoring?

Holter monitors, which are portable devices used to record heart activity over time, have been shown to effectively detect heart rhythm issues in both humans and animals during normal daily activities. This suggests that similar technology could be useful in monitoring fetal heart activity, providing continuous and detailed information that might be missed with shorter monitoring sessions.12345

Is the Holter device safe for use in humans?

Holter monitoring is generally considered safe for humans, as it is a noninvasive method used to record heart activity over time. It has been used in various settings, including monitoring fetal heart rates, without causing discomfort or harm.16789

How does the Holter Device for Fetal Monitoring differ from other treatments for fetal monitoring?

The Holter Device for Fetal Monitoring is unique because it allows for long-term recording of the fetal heart rate without causing discomfort to the mother, enabling monitoring outside the hospital during normal daily activities. This is different from traditional fetal monitoring methods, which are typically limited to short-term use in clinical settings.4561011

What is the purpose of this trial?

This is a feasibility study for a new application for capturing fetal cardiac activity. The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device.

Research Team

MG

Martin Frasch, MD, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This clinical trial is open to pregnant women carrying one or two babies, who are between 32 weeks gestation and full term. They should be after their routine antepartum testing with no specific exclusions mentioned.

Inclusion Criteria

I am pregnant with one or two babies, between 32 weeks and full term.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Holter ECG device and Doppler FHR device are attached to pregnant women to capture fetal cardiac activity

30 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

Treatment Details

Interventions

  • Holter Device
Trial Overview The study is testing if a Holter ECG device, typically used for heart monitoring, can also capture the heartbeat of an unborn baby. It will be compared to the standard Doppler Fetal Heart Rate monitor that's commonly used during pregnancy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Holter deviceExperimental Treatment1 Intervention
Holter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term

Holter Device is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Holter monitor for:
  • Cardiac arrhythmias
  • Fainting spells
  • Palpitations
  • Monitoring after myocardial infarction
🇪🇺
Approved in European Union as Holter monitor for:
  • Cardiac arrhythmias
  • Fainting spells
  • Palpitations
  • Monitoring after myocardial infarction
🇨🇦
Approved in Canada as Holter monitor for:
  • Cardiac arrhythmias
  • Fainting spells
  • Palpitations
  • Monitoring after myocardial infarction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Findings from Research

Holter monitoring is a valuable tool for assessing heart rate and rhythm changes in patients with conditions like coronary artery disease and chronic obstructive pulmonary disease, providing insights into disease severity and treatment responses.
Future advancements in Holter monitoring technology, such as miniaturization and automatic alert systems, could enhance its effectiveness and broaden its clinical applications, potentially offering insights comparable to those gained from monitoring patients in a hospital setting.
Observations on ambulatory electrocardiographic monitoring in clinical practice.Weinberg, SL.[2007]
Holter monitoring is a noninvasive method that allows for extended observation of heart rhythms during daily activities, revealing a higher incidence of serious arrhythmias than traditional electrocardiograms.
Unlike standard electrocardiograms that capture only brief moments, Holter monitoring provides a more comprehensive assessment, making it crucial for accurately diagnosing underlying arrhythmias.
Practical application of holter monitoring in dogs and cats.Petrie, JP.[2007]
The proposed intelligent heartbeat monitoring system can detect arrhythmias in real time with an impressive average accuracy of 97% in heartbeat detection and over 96% in heartbeat classification, based on testing with the MIT-BIH Arrhythmia Database.
This system utilizes advanced algorithms, such as the Pan-Tompkins algorithm for feature extraction and decision trees for classification, making it a reliable tool for continuous ECG analysis and decision support in Holter monitoring.
Intelligent classification of heartbeats for automated real-time ECG monitoring.Park, J., Kang, K.[2021]

References

Observations on ambulatory electrocardiographic monitoring in clinical practice. [2007]
Practical application of holter monitoring in dogs and cats. [2007]
Intelligent classification of heartbeats for automated real-time ECG monitoring. [2021]
Ambulatory electrocardiology. [2013]
The evolution of ambulatory ECG monitoring. [2017]
Effect of uterine contractions on fetal heart rate in pregnancy: a prospective observational study. [2017]
Ambulatory Holter electrocardiography: choice of technologies and clinical uses. [2019]
Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients. [2021]
Current Use and Future Needs of Noninvasive Ambulatory Electrocardiogram Monitoring. [2021]
An 8086-based Holter arrhythmia monitor. [2000]
[Long-term ECG analysis systems. Comparison of current methods]. [2007]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security