We will develop and prove a fetal spiral scalp probe for continuous intrapartum monitoring (CIM) of ECG, pH, p02, pC02 and temperature. This provides the labile fetal data (ECG, blood gasses) and data reflecting the totality of recent metabolic insults (pH, temp). The utility of CIM of fetal ECG and pH sampling are well known. The literature indicates CIM of p02, pC02 and fetal- maternal temperatures may be of value, and we believe they can be used to detect improper probe placement. The complete CIM data should enhance the reliability of fetal diagnosis and therapy. We have unique applicable experience. Our CIM spiral ECG/tissue pH probe was successfully evaluated in a 300 patient FDA IDE controlled study. We are testing a 430 micron diameter multiparameter (MP) intravascular probe for p02, pC02, pH and temperature. During Phase I we will adapt our MP system to the needs of CIM and complete the bench, toxicology and instrument qualification studies. During Phase II a pig subcutaneous pouch and fetal animal studies will be used to quantify the subcutaneous probe data vs. arterial and venus data. Later in Phase II, IDE controlled clinical trials of safety, effectiveness, and clinical significance will occur. Innovations are focused on practicality; design of spiral, applicator tool, pre-calibrated closed sterile probe (in development) measuring the relation of tissue data to blood data and meaningful display methods (Human Factors).
