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.
According to a recent World Health Organization Bulletin (Bulletin of the World Health Organization 2010;88:31-38. doi: 10.2471/BLT.08.062554) on preterm birth: "...Preterm birth is a significant perinatal health problem across the globe, not ony in terms of associated mortality but also with regard to short- and long-term morbidity and financial implications for health-care systems." "Unfortunately, there are currently no effective diagnostic measures for preterm labor resulting in preterm birth, and no effective early interventions for prevention." The reason why there are no effective treatments for preterm labor and birth is because our ability to accurately diagnose it early and to monitor it while treatments are administered is very limited. New, promising real-time, automated uterine EMG technology proposed herein may change this. And this is just one of the many potential benefits that this system brings to obstetricians and their pregnant patients. This diagnostic equipment could also potentially: reduce cesarean section rates, reduce unnecessary treatments and admissions, improve clinicians'ability to monitor efficacy of drug treatments, identify true labor patients, reduce neonatal morbidity and mortality, improve overall pregnant patient healthcare management and reduce associated healthcare costs!