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Fetal Electrocardiogram Extraction-Pilot Study

This study has been terminated.
(Indeterminate performance during the first half of the trial.)
Sponsor:
Information provided by (Responsible Party):
Huntleigh Healthcare Ltd
ClinicalTrials.gov Identifier:
NCT01681498
First received: August 30, 2012
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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


Condition Phase
Pregnancy
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Electrocardiogram Extraction-Pilot Study

Further study details as provided by Huntleigh Healthcare Ltd:

Primary Outcome Measures:
  • Beat-to-beat fetal heart rate will be compared to the Doppler result. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Evaluate the presence of other fECG intervals. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Prenatal care clinic

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681498

Locations
United States, Wisconsin
Wheaton Franciscan, Inc. - St. Joseph
Milwaukee, Wisconsin, United States, 53210
Sponsors and Collaborators
Huntleigh Healthcare Ltd
Investigators
Principal Investigator: Menachem H. Graupe, MD Wheaton Franciscan Healthcare
  More Information

No publications provided

Responsible Party: Huntleigh Healthcare Ltd
ClinicalTrials.gov Identifier: NCT01681498     History of Changes
Other Study ID Numbers: 12-010
Study First Received: August 30, 2012
Last Updated: September 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Huntleigh Healthcare Ltd:
pregnant
fetal ecg
ecg

ClinicalTrials.gov processed this record on November 20, 2014