Fetal Electrocardiogram Extraction-Pilot Study
Terminated
- Conditions
- Pregnancy
- Registration Number
- NCT01681498
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 20
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beat-to-beat fetal heart rate will be compared to the Doppler result. 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
Name Time Method Evaluate the presence of other fECG intervals. 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.
Trial Locations
- Locations (1)
Wheaton Franciscan, Inc. - St. Joseph
🇺🇸Milwaukee, Wisconsin, United States