OBJECTIVE: Current recommendations include the use of a vaginal speculum for fetal fibronectin specimen collection. This article evaluates the equivalency of nonspeculum methods for collecting fetal fibronectin specimens. STUDY DESIGN: Two separate prospective studies of patients more than 22 weeks' gestation were performed at 2 institutions with similar hypotheses and methods. Two sequential specimens were collected on each patient: 1 with speculum and 1 with the nonspeculum method. The order of collection was reversed or randomized in both studies. Two alternative nonspeculum collection methods are described. RESULTS: The 2 study sample sizes were 169 and 31. Comparison of the fetal fibronectin test results between the speculum and nonspeculum methods demonstrated greater than 95% agreement with an intraclass Kappa coefficient greater than 0.85 in both studies. The order of collection did not result in significantly different fetal fibronectin averages. CONCLUSION: These studies demonstrate that there is excellent agreement between fetal fibronectin results obtained by speculum and nonspeculum collection methods.
OBJECTIVE: Current recommendations include the use of a vaginal speculum for fetal fibronectin specimen collection. This article evaluates the equivalency of nonspeculum methods for collecting fetal fibronectin specimens. STUDY DESIGN: Two separate prospective studies of patients more than 22 weeks' gestation were performed at 2 institutions with similar hypotheses and methods. Two sequential specimens were collected on each patient: 1 with speculum and 1 with the nonspeculum method. The order of collection was reversed or randomized in both studies. Two alternative nonspeculum collection methods are described. RESULTS: The 2 study sample sizes were 169 and 31. Comparison of the fetal fibronectin test results between the speculum and nonspeculum methods demonstrated greater than 95% agreement with an intraclass Kappa coefficient greater than 0.85 in both studies. The order of collection did not result in significantly different fetal fibronectin averages. CONCLUSION: These studies demonstrate that there is excellent agreement between fetal fibronectin results obtained by speculum and nonspeculum collection methods.