Holter Device for Fetal Monitoring

Overseen By Amy Gest, MPA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to monitor a baby's heart activity before birth. Researchers aim to determine if a Holter device, a portable ECG device typically used to check heart activity over time, can also work for unborn babies. They will compare this method with the standard Doppler Fetal Heart Rate device. Pregnant women carrying one or two babies from 32 weeks to full term, who have undergone routine testing, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance prenatal care.

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 prior data suggests that this Holter device is safe for fetal monitoring?

Research has shown that the Holter monitor is generally safe for people. This device commonly tracks heart activity over time without major risks. Some individuals might experience slight discomfort or skin irritation where the sensors attach, but these issues are usually minor. The Holter monitor is noninvasive, meaning it doesn't involve surgery or entering the body, making it a safe choice for monitoring heart activity, even in pregnant women. The aim is to determine if it can also effectively capture the baby's heart signals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Holter device for fetal monitoring because it offers a non-invasive, continuous way to track fetal heart activity from 32 weeks of pregnancy until full term. Unlike traditional methods such as intermittent ultrasound or Doppler devices, which provide snapshots of fetal health at specific times, the Holter device continuously records data, giving a more comprehensive view of fetal well-being. This real-time monitoring can potentially help in detecting issues earlier and managing complications more effectively, leading to better outcomes for both mother and baby.

What evidence suggests that this Holter device is effective for fetal monitoring?

Studies have shown that the Holter device, used by participants in this trial, can effectively track a baby's heartbeat for extended periods without causing discomfort to the mother. Unlike the traditional Doppler method, which can sometimes be confusing or uncomfortable, the Holter device offers continuous and clear monitoring, making it especially useful for observing the baby's health. Research also suggests that this device may help detect issues like fetal tachycardias, unusually fast heartbeats that can lead to serious problems if not monitored. Overall, these findings indicate that the Holter device is a promising tool for safe and effective baby monitoring. ^{2 5 6 7 8}

Who Is on the Research Team?

Martin Frasch, MD, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Holter device Experimental Treatment 1 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

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+

Published Research Related to This Trial

In a study involving 29 patients with non-AF arrhythmias, the single-lead adhesive ECG device showed a higher noise burden compared to the Holter device, but both devices demonstrated excellent agreement in detecting key cardiac parameters like QRS complexes and ectopic beats.

Both monitoring methods provided coherent diagnoses by two cardiologists, suggesting that the single-lead adhesive device is a viable alternative for 24-hour ECG monitoring in patients with general arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients. Kwon, S., Lee, SR., Choi, EK., et al.[2021]

Continuous ambulatory ECG monitoring, especially with Holter systems, significantly improves the detection of transient atrial fibrillation in patients with cryptogenic stroke, even when standard ECG tests are negative.

Recent advancements in wearable ECG technology, including waterproof Holter systems and various forms of wearable monitors, are paving the way for enhanced remote monitoring of heart health and arrhythmias in both athletes and the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Use and Future Needs of Noninvasive Ambulatory Electrocardiogram Monitoring. Ikeda, T.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observations on ambulatory electrocardiographic monitoring in clinical practice. Weinberg, SL.[2007]

The invention of the Holter monitor 50 years ago has led to significant advancements in cardiac monitoring, allowing for long-term recording of heart activity through modern wearable and implantable devices.

Recent developments in telecommunication and computing have enhanced the ability of clinicians to remotely monitor and interpret cardiac events, improving the diagnosis and management of heart diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory electrocardiology. Romero, I.[2013]

Holter ECG monitoring has evolved significantly since the 1960s, transitioning from basic 1-channel devices to advanced 12-channel recorders with enhanced data analysis capabilities, allowing for more comprehensive heart monitoring.

The integration of smartphone technology and digital connectivity is paving the way for cost-effective, point-of-care Holter monitoring applications, which could greatly enhance global health by making heart health assessments more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of ambulatory ECG monitoring. Kennedy, HL.[2017]

The study successfully used a fetal Holter monitor to record fetal heart rates for an average of 18.8 hours in 12 healthy pregnant women, achieving a high success rate of 73.1% for fetal heart rate measurements.

Results indicated that increased uterine activity correlates with higher fetal heart rates, suggesting that uterine contractions may pose a physiological challenge that helps the fetal cardiovascular system adapt and develop.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of uterine contractions on fetal heart rate in pregnancy: a prospective observational study. Sletten, J., Kiserud, T., Kessler, J.[2017]

The new Holter monitor utilizes advanced digital signal processing and solid-state memories, replacing outdated analog methods, which enhances its ability to detect clinically significant arrhythmias.

Designed for portability and low power consumption, this 8086-based Holter monitor can effectively record ECG data for up to 24 hours in ambulatory patients, making it suitable for those with normal ECGs who experience heart issues under stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An 8086-based Holter arrhythmia monitor. Tandon, SN., Rahman, SM., Sahambi, JS., et al.[2000]

Holter monitoring has become a standard practice in hospitals and doctors' offices, leading to an increase in manufacturers producing Holter monitoring equipment.

The continuous recording system is considered the most advanced method for Holter monitoring, as it provides detailed ECG information and is adaptable to new technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term ECG analysis systems. Comparison of current methods]. Distler, WK.[2007]

Holter monitoring technologies, including continuous, patient-activated, and event recording modes, provide valuable ECG data for diagnosing arrhythmias, but their reliability can vary, especially with event recording.

While Holter monitoring is generally safe, there is a risk of false diagnoses due to recording issues and the potential misinterpretation of artifacts as true cardiac disturbances, highlighting the need for quality control in data analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Holter electrocardiography: choice of technologies and clinical uses. Morganroth, J.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligent classification of heartbeats for automated real-time ECG monitoring. Park, J., Kang, K.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612979/

Study on the clinical value of the wearable foetal ... The Thoth wearable FECG monitor offers several advantages over the traditional Doppler foetal heart monitoring system. These include a reduced confusion rate, ...

2. withpower.com withpower.com/trial/phase-5-2017-dec5f

Holter Device 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, ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e096123

Ambulatory foetal ECG monitoring in low and high-risk ... This study will provide a large amount of baseline FHR ECG data from uncomplicated pregnancies, which can be used to construct reference standards. This study ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013556

Clinical Role of the Noninvasive Abdominal Fetal ECG in ... Fetal tachycardias can cause adverse fetal outcomes including ventricular dysfunction, hydrops, and fetal demise. Postnatally, ECG is the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8842851/

Evaluation of an external fetal electrocardiogram ... A recent, small qualitative study has suggested that the external fetal ECG may be an acceptable method for longer term fetal monitoring in the ambulatory ...

6. mayoclinic.org mayoclinic.org/tests-procedures/holter-monitor/about/pac-20385039

Holter monitor There are no significant risks involved in wearing a Holter monitor. Some people have minor discomfort or skin irritation where the sensors were ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK597374/

Ambulatory ECG Monitoring - StatPearls - NCBI Bookshelf - NIH The primary advantage of the Holter monitor is the capture of an extended duration of ECG data, enabling the detection and analysis of transient ...

8. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/holter-monitor

Holter Monitor A Holter monitor is a type of portable electrocardiogram (ECG). It records the electrical activity of the heart over 24 hours or longer