Cervical biomarkers of preterm delivery

Period of Performance: 09/10/2007 - 09/09/2008


Phase 1 SBIR

Recipient Firm

Cervimark II, LLC
Saint Louis, MO 63117
Principal Investigator


DESCRIPTION (provided by applicant): Preterm labor, and subsequent delivery and care of premature infants, remains a major cause of infant mortality and morbidity. It is also a significant economic burden on society costing several billions of dollars a year, for the care of high-risk pregnant mothers, and the short- and long-term care of the prematurely delivered infants. Currently used diagnostic tests cannot accurately screen for the risk of preterm delivery in asymptomatic pregnant women. Premature softening of the uterine cervix during pregnancy results in premature cervical dilatation (opening) and effacement (thinning), and puts pregnant women at high risk of premature delivery. Studies in animals have lead to the discovery of several cervix-derived candidate biomarkers of premature cervical softening. Our hypothesis is that these candidate biomarkers will be consistently detected in human cervical secretion during pregnancy, and that quantitation of these candidate biomarkers will be useful in predicting premature cervical dilatation and preterm delivery in asymptomatic pregnant women. Our long- term goal is to use these biomarkers to develop a clinical test that would serve as the earliest sign of high-risk pregnancy in asymptomatic pregnant women. Our goal in Phase I is to assess feasibility of detection and quantitation of these candidate biomarkers, and to develop optimal test conditions for quantitation of these biomarkers in human cervical secretions. Premature delivery is a significant public health risk whose prevalence has not decreased during the past few decades; the financial and emotional cost of premature delivery has been on the increase at the same time. Our project aims to make a clinical test that would predict very early whether a pregnant women is at high risk to deliver prematurely. Early risk assessment, when there are no conventional symptoms of the delivery, will allow appropriate preparation on the part of the obstetrician and the pregnant women to prevent the premature delivery.