201. Fetal fibronectin detection in preterm labor: evaluation of a prototype bedside dipstick technique and cervical assessment.
- Author
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Coleman MA, McCowan LM, Pattison NS, and Mitchell M
- Subjects
- Adult, Female, Gestational Age, Humans, Immunoassay, Predictive Value of Tests, Pregnancy, Prospective Studies, Reagent Strips, Sensitivity and Specificity, Surgical Instruments, Cervix Mucus chemistry, Fibronectins analysis, Obstetric Labor, Premature diagnosis, Point-of-Care Systems
- Abstract
Objective: The aims of this study were to evaluate a prototype bedside test for fetal fibronectin detection in women with symptoms of preterm labor, to compare the efficacy of obtaining fetal fibronectin swabs with and without a speculum, and to assess the value of combining the fetal fibronectin test with cervical dilatation for predicting delivery within 10 days., Study Design: This investigation prospectively studied a cohort of women with symptoms of preterm labor (n = 121), gestational age between 24 and 33 6/7 weeks, and cervical dilatation =3 cm. Vaginal swabs for fibronectin testing with the bedside dipstick Fetal Fibronectin Membrane Immunoassay test (Adeza Biomedical, Sunnyvale, Calif) were obtained with and without a speculum. Results were not available to the clinicians., Results: Twenty-two percent of the fetal fibronectin samples collected with a speculum (27/121) yielded positive results. The incidence of delivery within 10 days of testing was 14% (17/121). Fetal fibronectin detection predicted delivery within 10 days with sensitivity, specificity, and positive and negative predictive values of 65%, 85%, 41%, and 94%, respectively. The positive and negative likelihood ratios were 4.3 and 0.41, respectively. There was substantial association between samples obtained with and without a speculum (Cohen kappa statistic 0.65, 95% confidence interval 0.44-0.87). Cervical dilatation >/=1 cm predicted delivery within 10 days with sensitivity, specificity, and positive and negative predictive values of 71%, 87%, 46%, and 95%, respectively, with positive and negative likelihood ratios of 5.5 and 0.33, respectively. Combination of fetal fibronectin testing with cervical dilatation >/=1 cm did not significantly improve the fetal fibronectin test characteristics. After exclusion of women with slight vaginal bleeding, cervical dilatation >/=1 cm and fetal fibronectin status remained the only independent variables associated with delivery within 10 days., Conclusion: Fetal fibronectin testing according to this prototype may have a limited role in clinical decision analysis. In this study a cervical dilatation >/=1 cm had predictive values equivalent to those of the fetal fibronectin test, and it should be evaluated further in a clinical setting.
- Published
- 1998
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