We will develop a new diagnostic test for use during pregnancy to identify women at elevated risk for preterm delivery (PTD). An immunoassay using a monoclonal antibody directed against oncofetal fibronectin (fFN), a pregnancy-related protein of placental origin found in the amniotic fluid, has been standardized for this purpose. Preliminary studies have shown that greater than 50 ng/ml of fFN was present in the cervicovaginal secretions of 81% of women at 23 to 36 weeks of gestation who sought medical attention for suspected rupture of membranes of PTD, in contrast to only 20% (p ess t an 0.001) of 267 women with uncomplicated term pregnancies. This difference could not be explained by differences in gestational age at sampling, cervical dilation or presence of blood in the secretions. The primary objective of Phase I will be to characterize the relationship between cervicovaginal fFN expression and the incidence of PTD in a longitudinal study of 100 high risk pregnancies. In Phase I, the investigators will design a prospective clinical trial to thoroughly evaluate the diagnostic efficacy of an anti-fFN assay for commercial application.Awardee's statement of the potential commercial applications of the research:Preterm delivery affects 5% to 10% of pregnancies, or approximately 350,000 births, and accounts for nearly 60% of perinatal morbidity and mortality. A cost effective, predictive diagnostic test for determining risk of preterm delivery would have broad appeal as a screening modality. Given the high incidence of the event, the deleterious effects on the fetus and the tremendous costs assumed for care of preterm infants, one or two tests per pregnancy could easily be justified.National Institute of Child Health and Human Development (NICHD)
