Northwestern Researchers Trial New Device that May Support Improved Newborn Health

Northwestern Medicine
Clinical Trials and Research January 13, 2012
Despite the numerous medical advances that happen every day, the infant mortality rate in the United States is still higher than most European countries. While experts believe this is closely linked to the growing rate of pre-term births, researchers are committed to finding ways to make labor and delivery safer. Northwestern Medicine® researchers are examining a new device that may support improved newborn health at delivery through closer monitoring of infant oxygen use during labor.

“Poor birth outcomes are often directly related to loss of oxygen during labor and delivery,” explained Alan Peaceman, MD, chief of maternal fetal medicine at Northwestern Memorial Hospital and professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine who is the lead investigator on the study. “Through more advanced monitoring, we hope to identify red flags sooner and prevent dips in oxygen that may lead to long-term health issues for the baby.”

STAN™ is fetal heart rate monitoring system that measures and tracks the electrical activity of the baby’s heart via an internal electrode, along with uterine contractions and how well the baby uses oxygen during labor. It then interprets the data and signals clinicians when a significant change in oxygen levels or heart rate occurs. The monitor is approved by the Food and Drug Administration and is routinely used in Europe, but has not been widely adopted in the United States yet. At present, it is only available for patients enrolled in the study. If this study demonstrates improved outcomes, it is likely that the monitoring system will become more widely available to mothers giving birth in this country.

“Current monitors measure heart rate alone, relying on the experience and judgment of the clinical team to interpret changes in data,” said Peaceman. “This system captures additional measurements and interprets that data, which may eliminate the guesswork and offer a more accurate assessment of how well the baby is using oxygen.”

Northwestern is one of 14 centers in the United States participating in the clinical trial, which researchers hope will enroll 11,000 women from across the country over the next three years. Subjects who opt to participate in this research study are randomly assigned to one of two groups. One will receive the standard fetal monitoring offered today, and the other will be monitored using the new system in addition to the existing method. The way in which fetal heart rate is monitored will be the only change to the labor and delivery experience, which will continue to be managed by the woman’s doctor.  For more information about the STAN clinical trial or to enroll, call 312-926-2475.

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