Landmark Study Suggests Improved Approach to Identifying Babies at Risk for Neonatal Depression as a Result of Excessive Uterine Contractions

PRINCETON, NJ — (Marketwired) — 09/17/13 — , the global leader in applying real-time clinical decision support to perinatal systems, announced today the findings of the largest clinical study of its kind on the incidence of overly frequent uterine contractions — commonly known as uterine tachysystole (UT) — and its association with undesirable birth outcomes. UT is a relatively common occurrence in childbirth and is generally considered a risk factor for Neonatal Depression. Digging further into the condition, however, the study shows that a better identifier of the risk of serious neonatal depression at birth is the presence of fetal heart rate decelerations in conjunction with excessive contractions. PeriCALMĀ® is the only FDA-cleared solution that enables real-time assessments of this key diagnostic relationship, providing a more discriminating approach to care coordination.

Aided by Patterns solution, this retrospective study examined heart rate tracings from 6,234 pregnant women from 2006 to 2010 at MedStar Franklin Square Medical Center in Baltimore, M.D., PeriGen-s electronic health record was used to extract the clinical data. UT was found in 18 percent labors ending with healthy babies. Only 1 percent of labors with UT went on to demonstrate serious problems at birth and this was not higher than the rate in women without UT.

Details of the four-year study titled “” are published in this month-s “Just Accepted” section of The Journal of Maternal-Fetal & Neonatal Medicine.

“Timely recognition of an impending problem and appropriate clinical intervention to prevent injury are basic obligations of all OB teams,” said Matthew Sappern, PeriGen-s CEO. “PeriCALM Patterns- analytics and unique graphical displays instantly show clinicians if UT is present, how long it has persisted and most critically, how the baby is responding to it over time. This is the key information they need to make the right decisions at the right time. We are very proud of our client MedStar Health-s outstanding achievements with this complication of labor.”

Uterine tachysystole can contribute to oxygen deprivation and birth related brain injury. It can occur spontaneously or secondary to prescribed drugs such as oxytocin. For this study, UT was defined by more than 15 contractions in 30 minutes. The adverse outcome, neonatal depression, was defined as a baby having either metabolic acidosis or a low five-minute Apgar score.

The study-s other authors are Samuel Smith, M.D., chairman, and Judy Zacharias, R.N., Department of Obstetrics and Gynecology at MedStar Franklin Square Medical Center, Vicki Lucas, R.N.C., Ph.D., and Philip Warrick, Ph.D., senior biomedical research engineer at PeriGen.

“We are committed to practicing evidence-based OB medicine and now we can do so even better using research originating from our own institution,” said Dr. Smith. “This is an extraordinary example of powerful synergy when you combine smart technology at the bedside, with well-trained frontline clinicians and attentive management. We-ve entered a new era where evidence drives clinical behavior. Long-held beliefs can be put to a scientific test, and we can base judgments on data and facts rather than solely on opinion.”

“MedStar placed our software at the bedside to assist in the early identification of UT, established policies about its appropriate management and reported regularly on clinician compliance,” said Emily Hamilton, M.D., PeriGen-s senior vice president of clinical research and a co-author of the study. “At the MedStar institution where these practices are upheld and where the study was conducted, UT was found to be generally short lived and almost always benign.”

“PeriGen is honored to collaborate with our long-time partner MedStar Health, well known for their extensive history of pursing high quality care,” added Sappern. “Our objective is to deliver innovative tools that support high quality perinatal care and facilitate leading-edge research.”

PeriGen, Inc., is an innovative provider of fetal surveillance systems employing patented, pattern-recognition and obstetrics technologies that empower perinatal clinicians to make confident, real-time decisions about the mothers and babies in their care. PeriGen-s customer-centric team of clinicians and technologists builds the most advanced systems available to augment obstetric decision-making and improve communications among the clinical team at the point of care, while supporting data flow between healthcare IT systems.

PeriGen-s unique fetal surveillance products provide dynamic visual cues that direct clinicians to the most essential patient information displayed on the screen. Unlike legacy fetal monitoring devices and software from non-specialist companies, PeriGen Visual Cueing provides an instant view of the mother-s and baby-s current status and trends over time to avoid errors, increasing patient safety and reducing risk for clinicians and hospitals. For more information, please visit us at .

Angela Jenkins
Amendola Communications for PeriGen
720.859.6930

Suzanne Trajkoski
Marketing Director
609.228.8346

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