NCT01681498TerminatedNot Applicable
Fetal Electrocardiogram Extraction-Pilot Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Huntleigh Healthcare Ltd
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Beat-to-beat fetal heart rate will be compared to the Doppler result.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Beat-to-beat fetal heart rate will be compared to the Doppler result.
Time Frame: 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 Outcomes
- Evaluate the presence of other fECG intervals.(2 years)
Investigators
Study Sites (1)
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