Holter Device for Fetal Monitoring
What You Need to Know Before You Apply
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.
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.
Is the Holter device safe for use in humans?
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.16789
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.4671011
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Holter ECG device and Doppler FHR device are attached to pregnant women to capture fetal cardiac activity
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Holter Device
Holter Device is already approved in United States, European Union, Canada for the following indications:
- Cardiac arrhythmias
- Fainting spells
- Palpitations
- Monitoring after myocardial infarction
- Cardiac arrhythmias
- Fainting spells
- Palpitations
- Monitoring after myocardial infarction
- 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
Duke University
Collaborator