Fetal Electrocardiogram Extraction-Pilot Study

Huntleigh Healthcare Ltd20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Wheaton Franciscan, Inc. - St. Joseph

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Beat-to-beat fetal heart rate will be compared to the Doppler result.

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.

Time frame: 2 years

Secondary Outcomes

Evaluate the presence of other fECG intervals.

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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