Suspended
Fetal Electrocardiogram Extraction-Pilot Study
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: May 2013
Summary
Principal SponsorHuntleigh Healthcare Ltd
Last updated: September 3, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.
Principal SponsorHuntleigh Healthcare Ltd
Last updated: September 3, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
4 inclusion criteria required to participate
Subject's fetus must be between the gestational ages of 16 weeks and term
Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study
Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position
Subjects must be pregnant women at least 18 years of age
1 exclusion criteria prevent from participating
Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Wheaton Franciscan, Inc. - St. Joseph
Milwaukee, United StatesOpen Wheaton Franciscan, Inc. - St. Joseph in Google MapsSuspendedOne Study Center