Clinical Studies on Fetal Fibronectin
Fetal fibronectin has been the subject of more than 150 peer-reviewed studies worldwide.
Goldenberg RL, Rouse DJ
Title: Prevention of premature birth
Source: N Engl J Med. 1998;339(5):313-20
Summary: "The available data on the effectiveness of various interventions aimed at reducing premature births provide an explanation for the epidemiologic observation that the rate of preterm birth is not declining."
Norwitz ER, Robinson JN, Challis JRG
Title: The control of labor
Source: N Engl J Med. 1999;341(9):660-66
Summary: "Considerable evidence suggests that the fetus controls the timing of labor and thus its birth, but exactly how is still unknown."
Ascarelli MH, Morrison JC
Title: Use of fetal fibronectin in clinical practice
Source: Obstet Gynecol Surv. 1997;52(4 Suppl):S1-12
Summary: "In low-risk asymptomatic patients, the positive predictive value [of FullTerm™, The Fetal Fibronectin Test] is lower (15-25 percent), but is important because women in this group, destined to deliver as a consequence of preterm labor, may have no other symptoms to forebode preterm delivery."
NIH Study CJ, Kuczynski E
Title: Risk stratification and pathological mechanisms in preterm delivery
Source: Paediatr Perinat Epidemiol. 2001;(15 Suppl) 2:78-89.
Summary: "...[A]nalysis of this model using a neural network will enable us to identify asymptomatic patients destined to deliver preterm with high sensitivity, specificity, positive and negative predictive values, and to assess the relative contribution of each of the four distinct pathogeneses to this preterm delivery risk."
Sibille Y, Lwebuga-Mukasa JS, Polomski L, et al
Title: An in vitro model for polymorphonuclear-leukocyte-induced injury to an extracellular matrix. Relative contribution of oxidants and elastase to fibronectin release from amniotic membranes
Source: Am Rev Respir Dis. 1986;134(1):134-40
Summary: "...[E]lastase rather than oxygen radicals solubilizes fibronectin from the matrix."
NIH Study CJ, Senyei AE, Dische MR, et al
Title: Fetal fibronectin in cervical and vaginal secretions as a predictor of preterm delivery.
Source: N Engl J Med. 1991;325(10):669-74
Summary: "The presence of cervicovaginal fetal fibronectin in the second and third trimesters of pregnancy identifies a subgroup of women who are at high risk for preterm delivery."
Iams JD, Casal D, McGregor JA, et al
Title: Fetal fibronectin improves the accuracy of diagnosis of preterm labor.
Source: Am J Obstet Gynecol. 1995;173(1):141-45
Summary: "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."
Peaceman AM, Andrews WW, Thorp JM, et al
Title: Fetal fibronectin as a predictor of preterm birth in patients with symptoms: a multicenter trial.
Source: Am J Obstet Gynecol. 1997;177(1):13-18
Summary: "...[T]he high negative predictive value of fetal fibronectin sampling supports less intervention for patients with this result."
Lopez RL, Francis JA, Garite TJ, Dubyak JM
Title: Fetal fibronectin detection as a predictor of preterm birth in actual clinical practice.
Source: Am J Obstet Gynecol. 2000;182(5):1103-06
Summary: "The positive predictive value of fetal fibronectin measured in actual clinical practice was significantly greater for delivery within 7 days than has been reported in blinded prospective studies."
Bartnicki J, Casal D, Kreaden US, et al
Title: Fetal fibronectin in vaginal specimens predicts preterm delivery and very-low-birth-weight infants.
Source: Am J Obstet Gynecol. 1996;174(3):971-74
Summary: "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."
Morrison JC, Allbert JR, McLaughlin BN, et al
Title: Oncofetal fibronectin in patients with false labor as a predictor of preterm delivery.
Source: Am J Obstet Gynecol. 1993;168(2):538-42
Summary: "A positive fetal fibronectin in women who have false labor indicates a significant risk for preterm labor and early delivery. A negative fetal fibronectin is a reassuring sign."
Iams JD, Goldenberg RL, Mercer BM, et al
Title: The preterm prediction study: recurrence risk of spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network
Source: Am J Obstet Gynecol. 1998;178(5):1035-40
Summary: "The study predicted that the recurrence risk of spontaneous preterm birth is increased by twofold to fourfold in women with a positive compared with a negative fetal fibronectin test result, and it increases as cervical length shortens in both fetal fibronectin-positive and fetal fibronectin-negative women."
Goldenberg RL, Mercer BM, Meis PJ, et al
Title: The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network
Source: Obstet Gynecol. 1996;87(5 Pt 1):643-48
Summary: "The study concluded that a positive cervical or vaginal fetal fibronectin test at 22-24 weeks predicted more than half of the spontaneous preterm births at less than 28 weeks (sensitivity 0.63)."
Goldenberg RL, Mercer BM, Iams JD, et al
Title: The preterm prediction study: patterns of cervicovaginal fetal fibronectin as predictors of spontaneous preterm delivery. NICHD Maternal Fetal Medicine Units Network.
Source: Am J Obstet Gynecol. 1997;177(1):8-12
Summary: "The study concluded that a positive cervical or vaginal fibronectin test result predicts subsequent positive fetal fibronectin positivity and subsequent preterm birth. The greater the percent of positive results, the higher is the risk of spontaneous preterm birth. After a positive test result, two negative results are required before the risk of spontaneous preterm birth returns to baseline."
NIH Study CJ, Wein R, Lapinski R, et al
Title: The presence of cervical and vaginal fetal fibronectin predicts preterm delivery in an inner-city obstetric population.
Source: Am J Obstet Gynecol. 1993;169(4):798-804
Summary: "The study concluded that among patients undergoing monthly cervical and vaginal sampling between 24 and 36 weeks' gestation, the presence of fetal fibronectin is a sensitive and specific predictor of preterm delivery."
Nageotte MP, Casal D, Senyei AE
Title: Fetal fibronectin in patients at increased risk for premature birth.
Source: Am J Obstet Gynecol. 1994;170(1 Pt 1):20-25
Summary: "Fetal fibronectin in the cervicovaginal secretions of asymptomatic patients has potential value as a screening test in the identification of patients at risk for preterm birth."
Bittar RE, Yamasaki AA, Sasaki S, Zugaib M
Title: Cervical fetal fibronectin in patients at increased risk for preterm delivery.
Source: Am J Obstet Gynecol. 1996;175(1):178-81
Summary: "The availability of a rapid search for the presence of cervical fetal fibronectin should improve our ability to efficiently identify patients at risk for preterm delivery to discriminate between such patients and those with benign Braxton Hicks contractions."
Kurtzman, James, MD.
Title: The Delivery Probability Profile: A new tool to predict PTD?
Source: Cont ObGyn. 2008; 53(1)
Summary: "Introduces the concept of a multifactorial delivery probability profile (DPP) that has the potential to predict PTD using data from fFN, CL and history of PTD to generate standard pregnancy survival curves."
Joffe GM, Jacques D, Bemis-Heys R, et al
Title: Impact of the fetal fibronectin assay on admissions for preterm labor
Source: Am J Obstet Gynecol. 1999;180(3 Pt 1):581-86
Summary: "Use of the fetal fibronectin assay resulted in significantly reduced preterm labor admissions, length of stay, and prescriptions for tocolytic agents."
Giles W, Bisits A, Knox M, et al
Title: The effect of fetal fibronectin testing on admissions to a tertiary maternal-fetal medicine unit and cost savings
Source: Am J Obstet Gynecol. 2000;182(2):439-42
Summary: "The use of a fetal fibronectin test was associated with a 90% reduction in maternal transfer and can substantially reduce the costs and inconvenience associated with unnecessary transfer."
Gilbert WM, Nesbitt TS, Danielson B
Title: The cost of prematurity: quantification by gestational age and birth weight
Source: Obstet Gynecol. 2003;102(3):488-92
Summary: "Prematurity, whether examined by gestational age or birth weight, is associated with significant neonatal hospital costs, all of which decrease exponentially with advancing gestational age."
Goldenberg RL, Iams JD, Mercer BM, et al
Title: The preterm prediction study: the value of new vs standard risk factors in predicting early and all spontaneous preterm births. NICHD Maternal Fetal Medicine Units Network.
Source: Am J Public Health. 1998;88(2):233-38
Summary: "Fetal fibronectin and a short cervix are stronger predictors of spontaneous preterm birth than traditional risk factors."
Rizzo G, Capponi A, Arduini D, et al
Title: The value of fetal fibronectin in cervical and vaginal secretions and of ultrasonographic examination of the uterine cervix in predicting premature delivery for patients with preterm labor and intact membranes
Source: Am J Obstet Gynecol. 1996;175(5):1146-51
Summary: "The assay of fetal fibronectin in cervical secretions is more accurate than ultrasonographic evaluation of the uterine cervix in the prediction of preterm delivery."
Rozenberg P, Goffinet F, Malagrida L, et al
Title: Evaluating the risk of preterm delivery: a comparison of fetal fibronectin and transvaginal ultrasonographic measurement of cervical length
Source: Am J Obstet Gynecol. 1997;176(1 Pt 1):196-99
Summary: "Fetal fibronectin and cervical length are approximately equivalent in their ability to distinguish between patients at high and low risk for preterm delivery."
Mozurkewich EL, Naglie G, Krahn MD, Hayashi RH
Title: Predicting preterm birth: a cost-effectiveness analysis
Source: Am J Obstet Gynecol. 2000;182(6):1589-98
Summary: "Risk prediction strategies with the fetal fibronectin assay or corticosteroids plus rapid fetal fibronectin testing or cervical length assessment may offer cost savings compared with treatment of all women with threatened preterm labor and may prevent similar numbers of cases of respiratory distress syndrome and neonatal deaths."
Burrus DR, Ernest JM, Veille JC
Title: Fetal fibronectin, interleukin-6, and C-reactive protein are useful in establishing prognostic subcategories of idiopathic preterm labor
Source: Am J Obstet Gynecol. 1995;173(4):1258-62
Summary: "Our purpose was to evaluate fetal fibronectin, interleukin-6, and C-reactive protein from patients with preterm labor to establish prognostic subcategories."
Iams JD, Goldenberg RL, Meis PJ, et al
Title: The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Units Network
Source: N Engl J Med. 1996;334(9):567-72
Summary: "The risk of spontaneous preterm delivery is increased in women who are found to have a short cervix by vaginal ultrasonography during pregnancy."
Inglis SR, Jeremias J, Kuno K, et al
Title: Detection of tumor necrosis factor-alpha, interleukin-6, and fetal fibronectin in the lower genital tract during pregnancy: relation to outcome
Source: Am J Obstet Gynecol. 1994;171(1):5-10
Summary: "Localized inflammatory responses may lead to microscopic disruption in the amniotic membranes, leading to leakage of fibronectin."
Gomez R, Romero R, Medina L, et al
Title: Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes
Source: Am J Obstet Gynecol. 2005;192(2):350-59
Summary: "...[E]xamine the diagnostic performance of ultrasonographic measurement of the cervical length and vaginal fetal fibronectin determination in the prediction of preterm delivery in patients with preterm uterine contractions and intact membranes."