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Objective: The purpose of this study was to evaluate the association of vaginal fetal fibronectin expression to risk of preterm delivery and delivery of very-low-birth-weight infants., Study Design: Vaginal secretions were obtained from women between 22 and 35 weeks' pregnant with minimal cervical dilation (< or = 2 cm) and threatened preterm delivery. The secretions were analyzed for the presence of fetal fibronectin. Other clinical information including cervical dimensions, uterine activity, serum C-reactive protein concentration, vaginal pH, evidence of vaginal or systemic infection, and vaginal bleeding were also obtained., Results: Of the 112 patients recruited, 40 (35.7%) were delivered prematurely (<37 weeks). For prediction of preterm delivery, the fetal fibronectin test result had a sensitivity, specificity, and positive and negative predictive values of 67.5, 90.3, 79.4, and 83.3%, respectively (odds ratio 19.3, p < 0.0001). Women with a positive fetal fibronectin test had a nearly 13-fold increased probability of being delivered of an infant weighing <1500 gm than did women with a negative fetal fibronectin test (32.4% vs 2.5%, p<0.0001). Categoric analysis and multiple logistic regression demonstrated that fetal fibronectin was an independent risk factor for prediction of preterm delivery and birth weight <1500 gm., Conclusion: Vaginal fetal fibronectin expression is an independent risk factor for preterm delivery and birth of very-low-birth-weight infants in symptomatic women with intact amniotic membranes and minimal cervical dilatation.

Objective: Our purpose was to assess the utility of cervicovaginal expression of fetal fibronectin in the diagnosis of preterm labor., Study Design: Women seen between 24 and 34 weeks' gestation with symptoms of preterm labor, intact membranes, and cervical dilatation < 3 cm were enrolled at five university medical centers. Cervicovaginal swabs were obtained and assayed for the presence of fetal fibronectin by means of a monoclonal antibody assay. Results were compared with cervical dilatation and uterine contraction frequency as indicators of interval to delivery and delivery before 37 weeks., Results: A total of 192 eligible women at a mean gestational age of 30.8 +/- 2.9 weeks were enrolled from a population of 418 subjects screened. The rate of preterm birth was 32.3% (62/192). The mean interval from presentation to delivery was 25.3 +/- 24.1 days in the 45 subjects with a positive fibronectin assay and 52.4 +/- 24.8 days in the 147 subjects with a negative assay (p = 0.0001). The sensitivity, specificity, and positive and negative predictive values of fetal fibronectin expression for delivery < 37 weeks were 44% (27/62), 86% (112/130), 60% (27/45), and 76% (112/147). The fetal fibronectin assay was especially useful in predicting risk of delivery within 7 days (sensitivity 93% [13/14], specificity 82% [146/178], positive predictive value 29% [13/45], and negative predictive value 99% [146/147]) and was notably superior to both cervical dilatation > 1 cm and contraction frequency greater than or equal to eight per hour (sensitivities 29% and 42%, specificities 82% and 67%, positive predictive values 11% and 9%, and negative predictive values 94% and 94%, respectively., Conclusion: Cervicovaginal fetal fibronectin predicts delivery within 7 days more accurately than do cervical dilatation and contraction frequency in a population of women evaluated for early preterm labor.