CLEVELAND, April 29, 2014 /PRNewswire-USNewswire/ -- Cervilenz Inc. is pleased to announce that a multicenter study evaluating the CerviLenz device as a screening tool for mid-pregnancy short cervical length is being presented today as a poster at the American College of Obstetricians and Gynecologists (ACOG) 2014 Annual Clinical Meeting in Chicago.1 CerviLenz is a simple, disposable device that can be used in any healthcare setting to objectively measure vaginal cervical length. A short cervix in the second trimester of pregnancy is the best predictor of preterm birth risk, an often devastating outcome affecting 11.5% of births in the United States.
The study was led by Jason Baxter, MD, a maternal-fetal medicine specialist at Thomas Jefferson University. The other investigators, also all maternal-fetal medicine specialists, and sites are: David Adair, MD at Regional Obstetrical Consultants; Michael Paidas, MD at Yale University; Asad Sheikh, MD at Spectrum Health; and Matthew Hoffman, MD at Christiana Care Health Services.
The primary objective of this research was to determine the CerviLenz measurement with optimal specificity and sensitivity to identify a short cervix by transvaginal ultrasound (TVU), which is considered the diagnostic test for cervical length. Based on measurements using CerviLenz and TVU by separate examiners in 358 pregnant women, a 30 mm CerviLenz measurement accurately identified patients with a TVU measurement less than or equal to 25 mm. The study concluded: “CerviLenz may be an evidence-based method supporting universal cervical length screening in clinical practice.”
Pregnant women with a mid-pregnancy short cervix are at extremely high risk of preterm birth, ten times that of those with a normal cervical length. ACOG2 and the Society for Maternal-Fetal Medicine2 (SMFM) both recommend vaginal progesterone treatment for singleton pregnancies with a TVU cervical length less than or equal to 20 mm in the second trimester. This intervention is shown to reduce early preterm birth by 45%, improve infant outcomes, and reduce NICU admissions.2,3,4 Screening pregnancies for a short cervical length is cost effective. An economic analysis concluded that universal screening and treatment with vaginal progesterone saves $19.6 million dollars for every 100,000 pregnancies.5
Michael Ross, MD, a maternal-fetal medicine specialist at Harbor-UCLA and Medical Director of Cervilenz Inc. noted, “These results validate other peer reviewed clinical studies demonstrating the efficacy of the CerviLenz device as a screening tool.” Dr. Ross continued, " Preterm birth remains the leading cause of infant mortality and morbidity, with the U.S. rate of preterm birth among the worst in the world. Progress has been made, but we must do more. Vaginal progesterone for short cervix is a vital next step in preterm birth prevention, and that creates an urgent need for universal cervical length screening to enable this life-saving treatment. The CerviLenz device is an innovative yet simple solution, allowing accurate cervical length measurement in any health care setting and that means equitable access to comprehensive preterm birth risk assessment for all pregnant women.”
About Cervilenz Inc.
Cervilenz Inc. manufactures and markets the CerviLenz® device, which measures vaginal cervical length to help physicians identify and manage pregnant women at high risk for preterm birth. Founded in 2008, Cervilenz Inc. is dedicated to making a difference in the world of prematurity. The company headquarters is in Chagrin Falls, a suburb of Cleveland, Ohio. CERVILENZ is a registered trademark of the Company in the U.S. The trademark CERVILENZ is also registered via a community trademark application in the European Union. The CerviLenz device is classified under 21 CFR 884.4530(2)(a.) as a 510(k) exempt device and has CE Mark and ISO 13485 Certification for international distribution. For more information, visit www.cervilenz.com or contact Melanie Sweeney, Vice President of Marketing (440.865.1474) or melanie@cervilenz.com).
About Preterm Birth
Preterm birth is the leading cause of perinatal morbidity and mortality. Nearly 15 million babies are born preterm every year worldwide. In the United States, preterm birth affects 11.5% of pregnancies, and its annual economic toll is $26.2 billion in health care and related costs.
References
1Baxter J, Adair D, Paidas M, et al. Utility of a cervicometer in assessing cervical length and risk of preterm birth: a multicenter study. Poster presented at 2014 Annual Clinical Meeting, American College of Obstetricians and Gynecologists.
2American College of Obstetricians and Gynecologists. ACOG practice bulletin no.130: prediction and prevention of preterm birth. Obstet Gynecol 2012 Oct;120(4):964-73.
3Society for Maternal-Fetal Medicine Publications Committee with the assistance of Vincenzo Berghella, MD. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206:376-386.
4Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multi-center, randomized, double-blind, placebo-controlled study. Ultrasound Obstet Gynecol 2011;38:18-31.
5Campbell S. Universal cervical length screening and vaginal progesterone prevents early preterm births, reduces neonatal morbidity and is cost saving: doing nothing is no longer an option. Ultrasound Obstet Gynecol 2011;38:1-9.
Melanie Sweeney
VP, Marketing
melanie@cervilenz.com
440.337.4253
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SOURCE Cervilenz Inc.
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