We propose to implement prototype instrumentation which will provide a novel means to acquire, process and present diagnostic quality fetal ECG waveforms and to utilize that instrumentation in a clinical study to assess fetal acidosis. This new technology would also help to prevent unnecessary Cesarean sections thus resulting in significant savings and reduction in the numbers and duration of hospital stays. Present methods of electronic fetal monitoring provide heart rate only. In preliminary studies we successfully employed an improved ECG lead arrangement and developed signal processing techniques to greatly enhance the weak fetal ECG signal complexes. We demonstrated the. feasibility to clinically acquire, process and present the fetal ECG T/QRS amplitude ratio which is associated with fetal acidosis. We extensively tested techniques to obtain fetal T/QRS ratio information in which we successfully employed a minimally invasive fetal ECG lead arrangement to achieve this. In a logical extension to this research, we propose to implement this study at several clinical centers. Our signal processing methods employ a new fetal ECG lead configuration, signal extraction techniques, and a novel means to selectively discriminate high quality fetal signals that accurately and precisely provide the fetal ECG waveform. Utilization of this instrumentation in a fetal ECG data collection project aimed at demonstrating the correlation of the fetal ECG T/QRS amplitude ratio with fetal blood pH, should provide a simple, cost effective, continuous, and accurate means to identify fetal acidosis.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Research Project (R01)
Project #
5R01RR010975-04
Application #
2797107
Study Section
Biomedical Research Technology Review Committee (BRC)
Project Start
1995-09-08
Project End
2000-09-07
Budget Start
1998-09-08
Budget End
2000-09-07
Support Year
4
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Perinatronics Medical Systems, Inc.
Department
Type
DUNS #
147255335
City
Crofton
State
MD
Country
United States
Zip Code
21108