General obstetrics and gynecology: obstetricsProspective randomized controlled trial of fetal fibronectin on preterm labor management in a tertiary care center☆
Section snippets
Material and methods
The study was approved by the University of Iowa Hospitals and Clinics Institutional Review Board. Women with signs and symptoms of preterm labor (uterine contractions and/or cervical change) who were examined at the University of Iowa Labor and Delivery Unit or those women who were transferred already receiving tocolytic medications were eligible for the study. Inclusion criteria were gestational age between 23 and 34 weeks, >16 years of age, cervical dilatation of ≤3 cm for primigravid women,
Results
A total of 110 patients were enrolled into the study between August 2000 and May 2002. Four women were excluded because of readmissions, 1 woman was found to have preterm premature rupture of membranes, 1 woman had an urgent cesarean delivery, and data from 1 woman was unable to be obtained because of blood in the vagina. Three women were assigned randomly to receive the fFN test but were discharged before it could be performed. One woman was found to be at >34 weeks of gestation, 1 woman was
Comment
In 1991, Lockwood et al4 published the first study in which the presence of fFN in preterm labor patients was associated with preterm delivery. Since then, several investigators have studied the ability of fFN to predict preterm delivery in women with symptoms of preterm labor and have found a negative predictive value for delivery within 1 week near 99% and 95% for 2 weeks.5., 6. These studies relied on the fFN enzyme immunoassay with a minimum turnaround time of 24 hours. Our study used the
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Cited by (45)
Compliance with Fetal Fibronectin Testing at a Canadian Tertiary Care Perinatal Centre
2021, Journal of Obstetrics and Gynaecology CanadaThreatened preterm birth: Validation of a nomogram to predict the individual risk of very preterm delivery in a secondary care center
2019, Journal of Gynecology Obstetrics and Human ReproductionCitation Excerpt :There was a high representation of admitted women with a gestational age of less than 24 weeks (24% of the cohort). Fetal fibronectin detection before 24 weeks must be use with caution because of its moderate value in predicting very preterm spontaneous birth: it could be partially explained by the physiological presence of fFN in cervicovaginal fluid in patients at less than 24 weeks [20]. Nomograms facilitate decision-making, but this prediction score should be implemented after a cost-effectiveness analysis is performed to determine whether the routine assessment of the risk of premature birth in cases of threatened preterm labor is a cost-effective strategy [21,22].
Randomized clinical trials are not always the best way to assess diagnostic tests: the case of fetal fibronectin testing
2018, American Journal of Obstetrics and GynecologyPrediction of preterm delivery in symptomatic women (preterm labor)
2016, Journal de Gynecologie Obstetrique et Biologie de la ReproductionFetal fibronectin testing for prevention of preterm birth in singleton pregnancies with threatened preterm labor: a systematic review and metaanalysis of randomized controlled trials
2016, American Journal of Obstetrics and GynecologyCitation Excerpt :Publication bias, which was assessed with the use of Begg’s and Egger’s tests, was not significant (P = .84 and .91, respectively). Authors of 4 trials were able to provide us additional unpublished data from their studies.7,9,10,12 Table 1 shows the characteristics of the included trials.
Biophysical and Biochemical Screening for the Risk of Preterm Labor: An Update
2016, Clinics in Laboratory MedicineCitation Excerpt :Importantly, the value of cervical lengths and FFN lies in their extremely high negative predictive values. FFN testing among symptomatic women in particular is associated with fewer hospital admissions for preterm labor, shorter lengths of stay, fewer medical interventions, and lower costs.14–18 FFN is not usually performed during this time period, as previously noted.
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Supported by Process Improvement Grant, University of Iowa.