Milwaukee, Wisconsin 53210

  • Pregnancy

Purpose:

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


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.


Study is Available At:


Original ID:

12-010


NCT ID:

NCT01681498


Secondary ID:


Study Acronym:


Brief Title:

Fetal Electrocardiogram Extraction-Pilot Study


Official Title:

Fetal Electrocardiogram Extraction-Pilot Study


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Huntleigh Healthcare Ltd


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Indeterminate performance during the first h


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Menachem H. Graupe, MD
Principal Investigator
Wheaton Franciscan Healthcare

Study Dates

Start Date:May 2013
Completion Date:May 2015
Completion Type:Anticipated
Primary Completion Date:May 2015
Primary Completion Type:Anticipated
Verification Date:September 2014
Last Changed Date:September 1, 2014
First Received Date:August 30, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Beat-to-beat fetal heart rate will be compared to the Doppler result.
Time Frame:2 years
Safety Issues:False
Description: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 obtai
Outcome Type:Secondary Outcome
Measure:Evaluate the presence of other fECG intervals.
Time Frame:2 years
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Pregnancy

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Huntleigh Healthcare Ltd

Samples and Retentions

Study Population: Prenatal care clinic
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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