Fully automating uterine electromyography (EMG) for real-time obstetric applicati

Reproductive Research Technologies, L P, Houston TX

Investigators

Abstract

DESCRIPTION (provided by applicant): Diagnosis of preterm labor is the most difficult and important task facing medical practitioners in maternity care today. Knowing when labor has begun as well as predicting when it will start is important for both normal and complicated pregnancies. Presently, there is no effective treatment of preterm labor. The most obvious reason for this anomaly is that there is no objective manner to evaluate the progression of pregnancy through steps leading to labor. Therefore, without methods to accurately diagnosis labor, treatment may never improve. Although preterm labor has major implications in OB-GYN, there are also tremendous healthcare cost ramifications in improving the ability to diagnose and monitor term pregnant patients, especially in regard to incorrectly admitting patients who are not in true labor, as well as incorrectly treating term patients with induction agents (such as oxytocin). It is extremely difficult to exercise proper patient management for women who present to labor and delivery with indications for delivery, but who are not clinically diagnosed as being in labor. Our preliminary studies provide convincing evidence that recording of EMG activity from the abdominal surface is clinically useful in evaluating the state of the uterus. RRT has already received FDA approval for uterine EMG patient monitoring methodology (See Appendix). However, no group has yet developed and utilized real-time, automated uterine EMG diagnostics in a clinical setting for term and preterm patient assessment and drug treatment efficacy monitoring. No other study has ever compared such a diagnostic system to clinical parameters head-to-head, in a variety of patient subgroups and scenarios. The overall goal of RRT is to develop a marketable and profitable product that will help pregnant women and their babies, and save many maternal and fetal lives. The innovative studies proposed herein will allow us to replace crude obstetric assessment instruments presently used, such as tocodynamometer (i.e. TOCO), with a truly objective device capable of measuring the onset and progress of labor, as well as providing a tool to develop better treatment strategies for pregnancy complications.