Summa Evaluates Clinical Device to Improve Care during Labor and Delivery
Summa Health System’s Center for Women’s Health Research (CWHR), Department of Obstetrics and Gynecology, under the direction of Michele McCarroll, Ph.D., is collaborating with Mindchild Medical, Inc. to conduct a clinical trial to improve fetal monitoring during labor.
MindChild, headquartered in Boston, is a privately funded medical device company founded in 2008. The CWHR received funding from MindChild to evaluate an innovative, quantitative system for analyzing fetal heart rate (FHR) tracings during labor. The device, called Meridian, uses sophisticated signal processing to obtain the non-invasive FHR.
Principal Investigator (PI) Timothy Drake, M.D., hospitalist in the Department of Obstetrics and Gynecology, and co-investigators will compare Meridian FHR tracings to traditional fetal monitoring, which has not changed in 30 years. For example, repetitive late decelerations during labor have been associated with hypoxia and negative outcomes and early identification of these tracings is important. However, current assessment of changes in FHR tracings is made by the individual obstetrician, who makes a subjective determination of the significance of the change. In comparison, Meridian analyzes aspects of the tracings such as slope of rate increase and duration of rate change, and provides classes of events, such as decelerations, on an objective basis. Meridian allows for an accurate and instantaneous assessment of changes to the fetus that may signal a problem during labor.
Approximately 400 women are expected to enroll in the MindChild study. More information on this clinical trial is available here.