Although widely practiced as the current standard of care, electronic fetal monitoring (EFM) has not significantly improved fetal outcomes. This is partially due to difficulties inherent in fetal heart rate and contraction tocography data interpretation. Oxygen saturation through pulse oximetry has become a standard for detection of hypoxemia in the critically ill patient. The addition of fetal oxygen saturation to the currently available EFM information has been discussed and investigated for several years but an acceptable method has not yet been devised. The major issue has been the lack of a reliable and practical method for attachment or application of the oximetry probe to the fetus in such a fashion to obtain a good pulse signal. We propose to develop a fetal oximetry system that will be reliable and, at the same time, cost effective. The major element of the proposed optical fetal pulse oximetry probe is to mount the emitters and detector in a fetal spiral electrode (FSE) similar to those used currently to measure fetal heart rate. Additionally, the design will integrate fetal heart rate capability with the fetal oximetry probe. The improved signal-to-noise ratio and elimination of movement artifacts will be combined with unique signal processing to give reliable oximetry data using an application method (FSE) already accepted as a standard for clinical use. The ultimate goal of the proposal is to improve fetal monitoring thereby reducing the morbidity, mortality and number of unnecessary cesarean sections.
This new fetal pulse oximetry probe could be used in many of the 4.3 million annual births in the United States. Assuming that only 20% of the births are monitored with the probe and with an estimated sales price of $40 this translates into a US sales volume of $34 million per year.
