• C J Lockwood, R Wein, R Lapinski, D Casal, G Berkowitz, M Alvarez, and R L Berkowitz.
• Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai School of Medicine, New York, NY 10029.
• Am. J. Obstet. Gynecol. 1993 Oct 1; 169 (4): 798-804.

ObjectiveIt has previously been shown that fibronectin bearing a specific oncofetal domain is present at the chorionic-decidual interface and that its release into cervical and vaginal secretions accurately predicts preterm delivery in patients with uterine contractions. This study examines whether serial assessment of cervical and vaginal fetal fibronectin allows for the prediction of preterm delivery in symptom-free patients derived from an inner-city, general obstetric population.Study DesignCervical and vaginal samples were obtained from 429 consenting patients who received routine prenatal care between 24 and 37 weeks' gestation. A sensitive immunoassay was used to quantitate cervical and vaginal fetal fibronectin levels, and clinicians were blinded to fetal fibronectin results. Post hoc receiver operating characteristic curve analysis was used to determine which sample site (cervical or vaginal), fetal fibronectin concentration, and number of consecutive positive samples optimized screening efficacy. Logistic regression was employed to determine whether fetal fibronectin was an independent predictor of preterm delivery.ResultsThe spontaneous preterm delivery rate was 11% (49/429). Among the 326 patients sampled within 28 days of delivery, receiver operating characteristic curve analysis indicated that the presence of a single cervical fetal fibronectin value > 60 ng/ml between 24 and 36 weeks' gestation predicted preterm delivery with a sensitivity of 73%, a specificity of 72%, and positive and negative predictive values of 25% and 95%, respectively. A vaginal fetal fibronectin value > 50 ng/ml predicted preterm delivery with a sensitivity of 68%, a specificity of 80%, and positive and negative predictive values of 30% and 95%, respectively. Cervical and vaginal fetal fibronectin predicted preterm deliveries resulting from both membrane rupture and preterm labor with intact membranes. A positive fetal fibronectin result preceded preterm delivery by 3.4 (+/- 3.2) weeks. Stepwise logistic regression demonstrated that cervical and vaginal fetal fibronectin levels were independent predictors of preterm delivery with adjusted odds ratios of 8.9 (95% confidence interval 3.6 to 22.1) and 6.0 (95% confidence interval 2.6 to 13.7), respectively.ConclusionsAmong patients undergoing monthly cervical and vaginal sampling between 24 and 36 weeks' gestation, the presence of fetal fibronectin is a sensitive and specific predictor of preterm delivery.

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