ResearchObstetricsA comparison of speculum and nonspeculum collection of cervicovaginal specimens for fetal fibronectin testing
Section snippets
Materials and Methods
Two separate studies were conducted to assess the agreement between the 2 collection methods. Both have similar hypotheses and study techniques. The first was a prospective study comparing the fFN specimen collection from the posterior fornix by using a nonspeculum digitally advanced method to a direct visualization by using a vaginal speculum. This study was performed at the Tijuana Hospital General Regional Numero Uno from Nov. 2004-June 2005. The Institutional Review Board of the study site
Results
In the first study, 238 women consented to enter the study. Eighteen different clinicians collected the specimens. Seventy (70) specimen pairs were excluded because of the presence of blood, leaving 169 paired samples for analysis. Neither the nonspeculum nor speculum swab was more likely to be contaminated with blood. The gestational ages ranged from 23-43 weeks with a mean value of 37 weeks. Both samples tested positive in 54 patients and both specimens tested negative in 107 patients,
Comment
The fFN test has become widely accepted as a tool for assisting in the management of the obstetric patient at risk for preterm delivery. The requirement of speculum examination for collection makes this test uncomfortable to some patients and must be performed by trained medical personnel. The requirement for speculum directed collection of the samples used for fFN testing exists primarily because this was the method used in the original studies and subsequently became the method prescribed in
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Cited by (22)
Biophysical and Biochemical Screening for the Risk of Preterm Labor: An Update
2016, Clinics in Laboratory MedicineCitation Excerpt :In order to improve patient acceptance and permit nonphysician personnel to obtain samples for FFN testing, investigators have evaluated blind collection techniques without a speculum examination. FFN test results following collection by speculum and blind methods were in agreement greater than 95% of the time, indicating excellent agreement as measured by the kappa statistic (κ = 0.90).12 Another study found that blind collection offered similar detection rates and negative predictive values to those observed with the recommended speculum examination.13
A comparison of prevaginal and postvaginal manipulation fetal fibronectin
2016, American Journal of Obstetrics and GynecologyCitation Excerpt :However, because our protocol did not specify this point, it is possible that some of the specimens were collected with a sterile speculum. While this may be a potential confounder, it is not expected to affect our results as previous data indicate excellent agreement of fFN results with and without a speculum.6,7 The high-risk nature of the women enrolled in our study, based on clinical risk factors in addition to symptoms of preterm labor, resulted in a higher preterm birth rate among our cohort compared to the national baseline.13
In appreciation of the leadership and stewardship of Drs Thomas J. Garite and Moon H. Kim
2014, American Journal of Obstetrics and GynecologyThe prediction of recurrent preterm birth in patients on 17-alpha-hydroxyprogesterone caproate using serial fetal fibronectin and cervical length
2012, American Journal of Obstetrics and GynecologyCitation Excerpt :A short CL was defined as a CL of 25 mm or less. Fetal fibronectin testing was performed using a Dacron swab without the use of a speculum according to an established protocol that has been validated previously by both our group10 and others.11 Fetal fibronectin testing was performed more than 24 hours from the last reported intercourse or endovaginal ultrasound and was not performed in the setting of vaginal bleeding.
Biophysical and biochemical screening for the risk of preterm labor
2010, Clinics in Laboratory MedicineCitation Excerpt :To improve patient acceptance and permit nonphysician personnel to obtain samples for FFN testing, investigators have evaluated “blind” collection techniques without a speculum examination. FFN test results after collection by speculum and blind methods were in agreement more than 95% of the time, indicating excellent agreement as measured by the κ statistic (κ = 0.90).12 Another study found that blind collection offered similar detection rates and negative predictive values in patients observed with the recommended speculum examination.13
Prediction of spontaneous preterm birth in asymptomatic twin pregnancies with the use of combined fetal fibronectin and cervical length
2009, American Journal of Obstetrics and GynecologyCitation Excerpt :The cutoff of 20 mm has been validated in other studies.5 FFN testing was performed with a Dacron swab without the use of a speculum, which is according to an established protocol that has been validated previously by both our group14 and others.15 FFN testing was performed >24 hours from the last reported intercourse or endovaginal ultrasound.
Cite this article as: Stafford IP, Garite TJ, Dildy GA, et al. A comparison of speculum and nonspeculum collection of cervicovaginal specimens for fetal fibronectin testing. Am J Obstet Gynecol 2008;199:131.e1-131.e4.
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