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Fetal Electrocardiogram Extraction-Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681498
Recruitment Status : Terminated (Indeterminate performance during the first half of the trial.)
First Posted : September 10, 2012
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
Huntleigh Healthcare Ltd

Brief Summary:
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.

Condition or disease

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Electrocardiogram Extraction-Pilot Study
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015


Primary Outcome Measures :
  1. Beat-to-beat fetal heart rate will be compared to the Doppler result. [ Time Frame: 2 years ]
    Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.

Secondary Outcome Measures :
  1. Evaluate the presence of other fECG intervals. [ Time Frame: 2 years ]
    The fECG Separation Algorithm used in this research incorporates the filtering of noise of very high level as compared with the signal to be retrieved , in combination with employment of SVD (Singular Value Decomposition) methods.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prenatal care clinic

Inclusion Criteria:

  • Subjects must be pregnant women at least 18 years of age.
  • Subject's fetus must be between the gestational ages of 16 weeks and term.
  • 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 are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.

Exclusion Criteria:

  • Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681498

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United States, Wisconsin
Wheaton Franciscan, Inc. - St. Joseph
Milwaukee, Wisconsin, United States, 53210
Sponsors and Collaborators
Huntleigh Healthcare Ltd
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Principal Investigator: Menachem H. Graupe, MD Wheaton Franciscan Healthcare
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Responsible Party: Huntleigh Healthcare Ltd Identifier: NCT01681498    
Other Study ID Numbers: 12-010
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Keywords provided by Huntleigh Healthcare Ltd:
fetal ecg