TECHNICAL FEASIBILITY STUDY OF A PREGNANCY LABOR MONITOR

DESCRIPTION (provided by applicant): This proposal is for the feasibility study and subsequent development of a new and improved uterine contractility monitor called The Labor Monitor. This device records uterine electromyographic (EMG) activity from external electrodes placed on the abdomen of the patient much like an electrocardiograph (ECG) monitors the activity of the heart. Uterine EMG monitors have the potential to detect the progress of term and more importantly, preterm labor. Tocodynamometer devices, the current standard of technology used to monitor labor in >95% of all pregnant patients, record uterine contractions via a strain gauge placed on the abdomen. Unfortunately, these devices are operator dependent, less sensitive and frequently inaccurate when monitoring progress of labor in preterm, high-risk pregnancies. Preterm labor and subsequent premature birth is the most common pregnancy complication today, placing approximately 20% of all pregnant women at significant risk. Premature birth and the attendant complications and contribute to approximately 85% of perinatal deaths worldwide (1-3). In the United States alone, preterm infants, defined as a birth weight less than 2500 grams, represent 10% of the 4 million babies born each year (1 ,6). At $1,500 per day for neonatal intensive care, this constitutes annual national healthcare expenditures in excess of $5 billion (2). Our current clinical results and experience with monitoring more than 400 patients will be incorporated into an engineering prototype system. The prototype electronics, hardware and software will be used to demonstrate the effectiveness of the Labor Monitor and to determine the specifications for a commercial device. The resulting device will be submitted to the FDA in a 510(K) application for approval as substantially equivalent to the existing tocodynamometer technology. We plan to further develop an enhanced monitoring system that will include labor prediction functionality. In this Phase I study, Reproductive Health Technologies, Inc. (RHT) will work with a consultant, Fairway Medical Technologies, Inc. (Houston, Texas) as detailed in the work plan. Specific objectives are to: 1) design and build a prototype labor monitor using the experience and expertise of RHT and Fairway, 2) test the prototype(s) in UTMB clinics, and 3) develop the specifications for an enhanced monitoring device for Phase II funding. KEY WORDS: pregnancy, labor, labor monitoring, preterm labor, and women's health.