Pregnancy
Conditions
Keywords
pregnant, fetal ecg, ecg
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.
Interventions
None listed
Sponsors
Huntleigh Healthcare Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed