Fetal Electrocardiogram Extraction-Pilot Study

Pregnancy Clinical Trial

Official title:

Fetal Electrocardiogram Extraction-Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01681498
• Other study ID #: 12-010
• Status: Terminated
• Phase: Phase 2
• First received: August 30, 2012
• Last updated: September 1, 2014
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: Huntleigh Healthcare Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	Wheaton Franciscan, Inc. - St. Joseph	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Huntleigh Healthcare Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Secondary	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.	2 years	No