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Varley-Campbell J, Mújica-Mota R, Coelho H, et al. Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2019 Mar. (Health Technology Assessment, No. 23.13.)
Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation.
Show detailsIncluded systematic reviews
Corabian P. The Actim™ Partus versus the TLiIQ® System as rapid response tests to aid in diagnosing preterm labour in symptomatic women (Structured abstract). Health Technol Assess 2008;(4). URL: http://onlinelibrary.wiley.com/o/cochrane/clhta/articles/HTA-32008100231/frame.html (accessed September 2017).
Corabian P, Guo B, Chojecki D, Wodinski L, Wanke M, Nguyen T, Chuck A. Post policy implementation review (PPIR) of rapid fetal fibronectin testing for preterm labour in Alberta (Structured abstract). Health Technol Assess 2015;(4). URL: http://onlinelibrary.wiley.com/o/cochrane/clhta/articles/HTA-32015001020/frame.html (accessed September 2017).
Conde-Agudelo A, Romero R. Cervical phosphorylated insulin-like growth factor binding protein-1 test for the prediction of preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol 2016;214:57–73. https://doi.org/10.1016/j.ajog.2015.06.060
Honest H, Bachmann LM, Gupta JK, Kleijnen J, Khan KS. Accuracy of cervicovaginal fetal fibronectin test in predicting risk of spontaneous preterm birth: systematic review. BMJ 2002;325:301.
Leitich H, Kaider A. Fetal fibronectin – how useful is it in the prediction of preterm birth? BJOG 2003;110(Suppl. 20):66–70.
Lucaroni F, Morciano L, Rizzo G, D’Antonio F, Buonuomo E, Palombi L, et al. Biomarkers for predicting spontaneous preterm birth: an umbrella systematic review. J Matern Fetal Neonatal Med 2017;31:1–9.
Menon R, Torloni MR, Voltolini C, Torricelli M, Merialdi M, Betrán AP, et al. Biomarkers of spontaneous preterm birth: an overview of the literature in the last four decades. Reprod Sci 2011;18:1046–70. https://doi.org/10.1177/1933719111415548
Sanchez-Ramos L, Delke I, Kaunitz A. Cervico-vaginal fetal fibronectin as a short-term predictor of preterm birth in symptomatic patients: A meta-analysis of diagnostic accuracy. Am J Obstet Gynecol 2007;197:S198-S.
Sanchez-Ramos L, Delke I, Zamora J, Kaunitz AM. Fetal fibronectin as a short-term predictor of preterm birth in symptomatic patients: a meta-analysis. Obstet Gynecol 2009;114:631–40. https://doi.org/10.1097/AOG.0b013e3181b47217
Smith V, Devane D, Begley CM, Clarke M, Higgins S. A systematic review and quality assessment of systematic reviews of fetal fibronectin and transvaginal length for predicting preterm birth. Eur J Obstet Gynecol Reprod Biol 2007;133:134–42.
Vis JY, Wilms FF, Oudijk MA, Bossuyt PM, van der Post JA, Grobman WA, Mol BW. Why were the results of randomized trials on the clinical utility of fetal fibronectin negative? A systematic review of their study designs. Am J Perinatol 2011;28:145–50. https://doi.org/10.1055/s-0030-1263297
Included citations
TABLE 27
Reference | Full text or abstract |
---|---|
Abo El-Ezz AE, Askar AE. Predictive value of phosphorylated insulin-like growth factor binding protein-1 (PIGFBP-1) (bedside test) in preterm labor. J Egypt Soc Parasitol 2014;44:525–30 | FT |
Altinkaya O, Gungor T, Ozat M, Danisman N, Mollamahmutoglu L. Cervical phosphorylated insulin-like growth factor binding protein-1 in prediction of preterm delivery. Arch Gynecol Obstet 2009;279:279–83. https://doi | FT |
Azlin MI, Bang HK, An LJ, Mohamad SN, Mansor NA, Yee BS, et al. Role of phIGFBP-1 and ultrasound cervical length in predicting pre-term labour. J Obstet Gynaecol 2010;30:456–9. https://doi | FT |
Azlin MN, Kee BH, Low JA, Mohamad SN, Mansor NA, Bee SY, et al. Role of phIGFBP-1 and cervical length in predicting preterm labor. J Maternal Fetal Neonatal Med 2010;23:100 | Ab |
Bolotskikh V, Borisova V. Combined value of placental alpha microglobulin-1 detection and cervical length via transvaginal ultrasound in the diagnosis of preterm labor in symptomatic patients. J Obstet Gynaecol Res 2017;43:1263–9. https://doi | FT |
Brik M, Hernández AI, Pedraz CC, Perales A. Phosphorylated insulin-like growth factor binding protein-1 and cervical measurement in women with threatening preterm birth. Acta Obstet Gynecol Scand 2010;89:268–74. https://doi | FT |
Bruijn M, Kamphuis E, Hoesli I, de Tejada BM, Loccufier A, Jacquemyn Y, et al. Does quantitative fetal fibronectin testing add to cervical length measurement and qualitative fetal fibronectin testing; (I) Identification of low risk women with threatened preterm labor (EUFIS study). Am J Obstet Gynecol 2015;212(Suppl. S):S190–1 | Ab |
Bruijn M, Kamphuis E, Hoesli I, de Tejada BM, Loccufier A, Jacquemyn Y, et al. Does quantitative fetal fibronectin testing add to cervical length measurement and qualitative fetal fibronectin testing; (II) absolute probability of preterm delivery < 7 days in women with threatened preterm labor (EUFIS study). Am J Obstet Gynecol 2015;212:S191–2 | Ab |
Bruijn M, van Baaren G-J, Vis J, van Straalen J, Wilms F, Oudijk M, et al. Does quantitative fetal fibronectin testing improve the prediction of spontaneous preterm delivery as compared to qualitative fetal fibronectin testing in symptomatic women: a post-hoc analysis. Am J Obstet Gynecol 2014;210(Suppl. S):S364 | Ab |
Bruijn M, van Baaren G-J, Vis J, van Straalen J, Wilms F, Oudijk M, et al. Comparison of the Actim Partus test and fetal fibronectin test in combination with cervical length in the prediction of spontaneous preterm delivery in symptomatic women: a post-hoc analysis. Am J Obstet Gynecol 2014;210(Suppl. S):S363–4 | Ab |
Bruijn M, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, et al. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women. BJOG 2016;123:1965–71. https://doi | FT |
Bruijn MM, Kamphuis EI, Hoesli IM, Martinez de Tejada B, Loccufier AR, Kühnert M, et al. The predictive value of quantitative fibronectin testing in combination with cervical length measurement in symptomatic women. Am J Obstet Gynecol 2016;215:793.e1–793.e8 | FT |
Bruijn MM, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, et al. Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement. Eur J Obstet Gynecol Reprod Biol 2016;206:220–4 | FT |
Cooper S, Lange I, Wood S, Tang S, Miller L, Ross S. Diagnostic accuracy of rapid phIGFBP-I assay for predicting preterm labor in symptomatic patients. J Perinatol 2012;32:460–5. https://doi | FT |
Danti L, Prefumo F, Lojacono A, Corini S, Testori A, Frusca T. The combination of short cervical length and phIGFBP-1 in the prediction of preterm delivery in symptomatic women. J Matern Fetal Neonatal Med 2011;24:1262–6. https://doi | FT |
Eroglu D, Yanik F, Oktem M, Zeyneloglu HB, Kuscu E. Prediction of preterm delivery among women with threatened preterm labor. Gynecol Obstet Invest 2007;64:109–16 | FT |
Goyal M, Kriplani A, Kachhawa G, Badiger S. Prediction of preterm labor by a rapid bedside test detecting phosphorylated insulin-like growth factor-binding protein 1 in cervical secretions. Int J Gynaecol Obstet 2016;134:165–8. https://doi | FT |
Hadzi-Lega M, Daneva A, Girevski V. EP18.02: Comparison of PartoSure (PAMG-1) and Actim Partus (phlGFBP-1) for the prediction of preterm delivery in patients with preterm labour and a short cervix. Ultrasound Obstet Gynecol 2016;48:345–6 | Ab |
Hadzi-Lega M, Hellmeyer L, Hanns H, Josefine M, Poposka A, Daneva Markova A. Comparison of PartoSure (PAMG-1) and Actim Partus (phLGFBP-1) for the prediction of preterm delivery in patients with preterm labor and a short cervix. J Maternal Fetal Neonatal Med 2016;29:55 | Ab |
Hadzi-Lega M, Maier JT, Helmer H, Hellmeyer L, Markova AD, Poposka A. Comparison of PAMG-1 and phIGFBP-1 tests for the prediction of preterm delivery in patients with preterm labor. Open J Obstet Gynecol 2017;7:11 | FT |
Lembet A, Eroglu D, Ergin T, Kuscu E, Haberal A, Gaddipati S. A new bed-side test for the prediction of preterm delivery: Phosphorylated insulin-like growth factor binding protein-1 in cervical secretions. Am J Obstet Gynecol 2001;185(Suppl. 6):S147 | Ab |
Lembet A, Eroglu D, Ergin T, Kuscu E, Zeyneloglu H, Batioglu S, Haberal A. New rapid bed-side test to predict preterm delivery: phosphorylated insulin-like growth factor binding protein-1 in cervical secretions. Acta Obstet Gynecol Scand 2002;81:706–12 | FT |
Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Evaluation of a novel PAMG-1 test (partosurea TTD test) to predict time to delivery in patients with preterm labor. Abstract number 1731. Moscow: 11th World Congress of Perinatal Medicine; 2013 | Ab |
Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery. J Perinat Med 2014;42:473–7. https://doi | FT |
Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Comparison of a novel test for placental alpha microglobulin-1 with fetal fibronectin and cervical length measurement for the prediction of imminent spontaneous preterm delivery in patients with threatened preterm labor. J Perinat Med 2015;43:395–402. https://doi | FT |
Riboni F, Vitulo A, Dell’avanzo M, Plebani M, Battagliarin G, Paternoster D. Biochemical markers predicting pre-term delivery in symptomatic patients: phosphorylated insulin-like growth factor binding protein-1 and fetal fibronectin. Arch Gynecol Obstet 2011;284:1325–9. https://doi | FT |
Tanir HM, Sener T, Yildiz Z. Cervical phosphorylated insulin-like growth factor binding protein-1 for the prediction of preterm delivery in symptomatic cases with intact membranes. J Obstet Gynaecol Res 2009;35:66–72. https://doi | FT |
Ting HS, Chin PS, Yeo GS, Kwek K. Comparison of bedside test kits for prediction of preterm delivery: phosphorylated insulin-like growth factor binding protein-1 (pIGFBP-1) test and fetal fibronectin test. Ann Acad Med Singap 2007;36:399–402 | FT |
Tripathi R, Tyagi S, Mala YM, Singh N, Pandey NB, Yadav P. Comparison of rapid bedside tests for phosphorylated insulin-like growth factor-binding protein 1 and fetal fibronectin to predict preterm birth. Int J Gynaecol Obstet 2016;135:47–50. https://doi | FT |
Vishwekar PS, Chauhan AR, Turakhia N. Prediction of preterm delivery with a novel bedside test. Int J Reprod Contracept Obstet Gynecol 2017;6:3366–71 | FT |
Werlen S, Raia T, Di Bartolomeo A, Chauleur C. [Preterm labor: Reproducibility of detection test of PAMG-1 before and after digital examination, and transvaginal ultrasound cervical length.] Gynecol Obstet Fertil 2015;43:640–5. https://doi | FT |
Ab, abstract; FT, full text.
Alere Inc. (Actim Partus) submitted citations
TABLE 28
Citation | Reason for exclusion | Further detail |
---|---|---|
Adeyemi O, Osoba L. The role of phosphorylated insulin-like growth factor binding protein-1 in predicting pre-term labour in twin pregnancies. J Obstet Gynaecol 2010;30:571–3. https://doi | Population | Twin pregnancies |
Akercan F, Kazandi M, Sendag F, Cirpan T, Mgoyi L, Terek MC, Sagol S. Value of cervical phosphorylated insulinlike growth factor binding protein-1 in the prediction of preterm labor. J Reprod Med 2004;49:368–72 | Comparator | Outcome at 37 weeks |
Altinkaya O, Gungor T, Ozat M, Danisman N, Mollamahmutoglu L. Cervical phosphorylated insulin-like growth factor binding protein-1 in prediction of preterm delivery. Arch Gynecol Obstet 2009;279:279–83. https://doi | Included | |
Azlin MI, Bang HK, An LJ, Mohamad SN, Mansor NA, Yee BS, et al. Role of phIGFBP-1 and ultrasound cervical length in predicting pre-term labour. J Obstet Gynaecol 2010;30:456–9. https://doi | Included | |
Balić D, Latifagić A, Hudić I. Insulin-like growth factor-binding protein-1 (IGFBP-1) in cervical secretions as a predictor of preterm delivery. J Matern Fetal Neonatal Med 2008;21:297–300. https://doi | Population | Asymptomatic population |
Bittar RE, da Fonseca EB, de Carvalho MH, Martinelli S, Zugaib M. Predicting preterm delivery in asymptomatic patients with prior preterm delivery by measurement of cervical length and phosphorylated insulin-like growth factor-binding protein-1. Ultrasound Obstet Gynecol 2007;29:562–7. https://doi | Population | Asymptomatic population |
Brik M, Hernández AI, Pedraz CC, Perales A. Phosphorylated insulin-like growth factor binding protein-1 and cervical measurement in women with threatening preterm birth. Acta Obstet Gynecol Scand 2010;89:268–74. https://doi | Included | |
Bruijn MM, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, et al. Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement. Eur J Obstet Gynecol Reprod Biol 2016;206:220–4 | Included | |
Cooper S, Lange I, Wood S, Tang S, Miller L, Ross S. Diagnostic accuracy of rapid phIGFBP-I assay for predicting preterm labor in symptomatic patients. J Perinatol 2012;32:460–5. https://doi | Included | |
Danti L, Prefumo F, Lojacono A, Corini S, Testori A, Frusca T. The combination of short cervical length and phIGFBP-1 in the prediction of preterm delivery in symptomatic women. J Matern Fetal Neonatal Med 2011;24:1262–6. https://doi | Included | |
Dögl M, Skogvoll E, Heimstad R. Cervical insulin-like growth factor binding protein-1 (IGFBP-1) to predict spontaneous onset of labor and induction to delivery interval in post-term pregnancy. Acta Obstet Gynecol Scand 2011;90:57–62. https://doi | Population | Post-term pregnancies |
Elizur SE, Yinon Y, Epstein GS, Seidman DS, Schiff E, Sivan E. Insulin-like growth factor binding protein-1 detection in preterm labor: evaluation of a bedside test. Am J Perinatol 2005;22:305–9. https://doi | Population | Not clear if multifetal, also outcome at 35 weeks |
Eroglu D, Yanik F, Oktem M, Zeyneloglu HB, Kuscu E. Prediction of preterm delivery among women with threatened preterm labor. Gynecol Obstet Invest 2007;64:109–16 | Included | |
Hadži-Lega M, Markova AD, Stefanovic M, Tanturovski M. Correlation of cervical length, fetal fibronectin, phIGFBP-1, and cytokines in spontaneous preterm birth up to 14 days from sampling. J Perinat Med 2015;43:545–51. https://doi | Comparator | Outcome at 14 days |
Kekki M, Kurki T, Kärkkäinen T, Hiilesmaa V, Paavonen J, Rutanen EM. Insulin-like growth factor-binding protein-1 in cervical secretion as a predictor of preterm delivery. Acta Obstet Gynecol Scand 2001;80:546–51 | Outcome | Unclear what time reference is, also includes multifetal |
Kekki M, Kurki T, Paavonen J, Rutanen EM. Insulin-like growth factor binding protein-1 in cervix as a marker of infectious complications in pregnant women with bacterial vaginosis. Lancet 1999;353:1494 | Study design | Letter |
Khambay H, Bolt LA, Chandiramani M, De Greeff A, Filmer JE, Shennan AH. The Actim Partus test to predict pre-term birth in asymptomatic high-risk women. J Obstet Gynaecol 2012;32:132–4. https://doi | Population | Asymptomatic |
Kosinska-Kaczynska K, Bomba-Opon D, Bobrowska K, Kozlowski S, Brawura-Biskupski-Samaha R, Szymusik I, et al. Phosphorylated IGFBP-1 in predicting successful vaginal delivery in post-term pregnancy. Arch Gynecol Obstet 2015;292:45–52. https://doi | Population | Post-term population |
Kwek K, Khi C, Ting HS, Yeo GS. Evaluation of a bedside test for phosphorylated insulin-like growth factor binding protein-1 in preterm labour. Ann Acad Med Singap 2004;33:780–3 | Population | Unclear if includes multifetal |
Latifagic A, Balic D, Fatusic Z, Hudic I, Kapidzic M, Habibovicd A. Insulin-like growth factor-binding protein-1 (IGFBP-1) in cervical secretions in women with symptoms of preterm delivery. Med Glas 2008;5:121–4 | Outcome | Unclear what time reference is |
Lembet A, Eroglu D, Ergin T, Kuscu E, Zeyneloglu H, Batioglu S, Haberal A. New rapid bed-side test to predict preterm delivery: phosphorylated insulin-like growth factor binding protein-1 in cervical secretions. Acta Obstet Gynecol Scand 2002;81:706–12 | Included | |
Mešić Ðogić L, Mićić D, Omeragić F, Kovač R, Fazlagić S. IGFBP-1 marker of cervical ripening and predictor of preterm birth. Med Glas 2016;13:118–24. https://doi | Population | Asymptomatic population |
Nuutila M, Hiilesmaa V, Kärkkäinen T, Ylikorkala O, Rutanen EM. Phosphorylated isoforms of insulin-like growth factor binding protein-1 in the cervix as a predictor of cervical ripeness. Obstet Gynecol 1999;94:243–9 | Population | Term population |
Park OR, Kim JK, Chang BS, Kim HJ, Kim TS, Park IS, et al. Usefulness of phosphorylated insulin-like growth factor binding protein-1 for prediction of preterm delivery. Korean J Obstet Gynecol 2003;46:1378–83 | Language | |
Paternoster DM, Muresan D, Vitulo A, Serena A, Battagliarin G, Dell’avanzo M, Nicolini U. Cervical phIGFBP-1 in the evaluation of the risk of preterm delivery. Acta Obstet Gynecol Scand 2007;86:151–5 | Outcome | Outcome at 34 weeks |
Rahkonen L. Prediction of pre-term delivery with phosphorylated insulin-like growth factor-binding protein-1. Eur J Obstet Gynecol 2011;6:3–7 | Study design | Review |
Riboni F, Vitulo A, Dell’avanzo M, Plebani M, Battagliarin G, Paternoster D. Biochemical markers predicting pre-term delivery in symptomatic patients: phosphorylated insulin-like growth factor binding protein-1 and fetal fibronectin. Arch Gynecol Obstet 2011;284:1325–9. https://doi | Included | |
Riboni F, Vitulo A, Plebani M, Dell’avanzo M, Battagliarin G, Paternoster D. Combination of biochemical markers in predicting pre-term delivery. Arch Gynecol Obstet 2012;285:61–6. https://doi | Population | Asymptomatic |
Rolnik DL, Bittar RE, de Carvalho MH, Zugaib M, Francisco RP. [Preterm birth prediction: sequential evaluation of the cervix and the test for phosphorylated protein-1 linked to insulin-like growth factor.] Rev Bras Ginecol Obstet 2013;35:394–400 | Population | Asymptomatic |
Shine BK, Kim SJ, Park WI, Kim JO, Kim DW, Hong SY, Yoon HS. Insulin-like growth factor-binding protein-1 in cervical secretion as a predictor of preterm delivery. Korean J Obstet Gynecol 2001;44:2250–6 | Language | |
Tanir HM, Sener T, Yildiz Z. Cervical phosphorylated insulin-like growth factor binding protein-1 for the prediction of preterm delivery in symptomatic cases with intact membranes. J Obstet Gynaecol Res 2009;35:66–72. https://doi | Included | |
Ting HS, Chin PS, Yeo GS, Kwek K. Comparison of bedside test kits for prediction of preterm delivery: phosphorylated insulin-like growth factor binding protein-1 (pIGFBP-1) test and fetal fibronectin test. Ann Acad Med Singap 2007;36:399–402 | Included | |
Tripathi R, Tyagi S, Mala YM, Singh N, Pandey NB, Yadav P. Comparison of rapid bedside tests for phosphorylated insulin-like growth factor-binding protein 1 and fetal fibronectin to predict preterm birth. Int J Gynaecol Obstet 2016;135:47–50. https://doi | Included | |
Vallikkannu N, Lam WK, Omar SZ, Tan PC. Insulin-like growth factor binding protein 1, Bishop score, and sonographic cervical length: tolerability and prediction of vaginal birth and vaginal birth within 24 hours following labour induction in nulliparous women. BJOG 2017;124:1274–83. https://doi | Population | Term women, labour induction |
Hologic, Inc. (fFN) submitted citations
TABLE 29
Citation | Reason for exclusion | Further detail |
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Abbott D, Radford S, Foster C, Vousden N, Shennan A. Longitudinal trend of quantitative fetal fibronectin in the prediction of delivery following insertion of a rescue cerclage. J Obstet Gynaecol 2013;33:414–15. https://doi | Study design | Case study |
Abbott DS, Hezelgrave NL, Seed PT, Norman JE, David AL, Bennett PR, et al. Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk. Obstet Gynecol 2015;125:1168–76. https://doi | Population | Asymptomatic population |
Abbott DS, Radford SK, Seed PT, Tribe RM, Shennan AH. Evaluation of a quantitative fetal fibronectin test for spontaneous preterm birth in symptomatic women. Am J Obstet Gynecol 2013;208:122.e1–6. https://doi | Comparator | Outcome at 14 days |
Anderson-Knight HE, Hezelgrave NL, Shennan AH. Spontaneous resolution of a midtrimester dilated cervix with expectant management guided by quantitative foetal fibronectin results. J Obstet Gynaecol 2015;35:766–7. https://doi | Study design | Case study |
Bolt LA, Chandiramani M, De Greeff A, Seed P, Shennan AH. Does fetal fibronectin testing change patient management in women at risk of preterm labour? Eur J Obstet Gynecol Reprod Biol 2009;146:180–3. https://doi | Comparator | Outcome at 14 days |
Bolt LA, Chandiramani M, De Greeff A, Seed PT, Kurtzman J, Shennan AH. The value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women. J Matern Fetal Neonatal Med 2011;24:928–32. https://doi | Population | Asymptomatic population |
Bolt LA, Morrison K, Shennan AH. The use of fetal fibronectin testing and cervical length measurement in the prediction of delivery of triplet pregnancies. Eur J Obstet Gynecol Reprod Biol 2012;164:236–7. https://doi | Population | Triplet pregnancies |
Bruijn M, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, et al. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women. BJOG 2016;123:1965–71. https://doi | Included | |
Bruijn MM, Kamphuis EI, Hoesli IM, Martinez de Tejada B, Loccufier AR, Kühnert M, et al. The predictive value of quantitative fibronectin testing in combination with cervical length measurement in symptomatic women. Am J Obstet Gynecol 2016;215:793.e1–793.e8 | Included | |
Centra M, Coata G, Picchiassi E, Alfonsi L, Meniconi S, Bini V, et al. Evaluation of quantitative fFn test in predicting the risk of preterm birth. J Perinat Med 2017;45:91–8. https://doi | Comparator | Outcome at 14 days |
Fiorini F, Isted A, Hezelgrave NL, Shennan AH. Quantitative fetal fibronectin predicts preterm birth in women with bulging fetal membranes. Eur J Obstet Gynecol Reprod Biol 2016;203:127–31. https://doi | Comparator | Outcome at 14 days |
Foster C, Shennan AH. Fetal fibronectin as a biomarker of preterm labor: a review of the literature and advances in its clinical use. Biomark Med 2014;8:471–84. https://doi | Study design | Literature review |
Gibson S, Hezelgrave NL, Shennan AH. Management of vasa praevia: a potential role for cervical length and quantitative fetal fibronectin measurement. J Obstet Gynaecol 2013;33:905–6. https://doi | Study design | Case study |
Goepfert AR, Goldenberg RL, Mercer B, Iams J, Meis P, Moawad A, et al. The preterm prediction study: quantitative fetal fibronectin values and the prediction of spontaneous preterm birth. The National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol 2000;183:1480–3 | Population | Asymptomatic population |
Goldenberg RL, Iams JD, Mercer BM, Meis PJ, Moawad AH, Copper RL, et al. The preterm prediction study: the value of new vs standard risk factors in predicting early and all spontaneous preterm births. NICHD MFMU Network. Am J Public Health 1998;88:233–8 | Population | Asymptomatic population |
Goldenberg RL, Klebanoff M, Carey JC, Macpherson C, Leveno KJ, Moawad AH, et al. Vaginal fetal fibronectin measurements from 8 to 22 weeks’ gestation and subsequent spontaneous preterm birth. Am J Obstet Gynecol 2000;183:469–75 | Population | Asymptomatic population |
Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth; NICHD maternal fetal medicine units network. Obstet Gynecol 1996;87:643–8 | Population | Asymptomatic population |
Golic M, Siedentopf JP, Pauly F, Hinkson L, Henrich W, Tucher E. Influence of transvaginal ultrasound examination on quantitative vaginal fibronectin measurements: a prospective evaluation study. J Perinat Med 2017;45:85–9. https://doi | Outcome | Does not report test accuracy data |
Hezelgrave NL, Kuhrt K, Cottam K, Seed PT, Tribe RM, Shennan AH. The effect of blood staining on cervicovaginal quantitative fetal fibronectin concentration and prediction of spontaneous preterm birth. Eur J Obstet Gynecol Reprod Biol 2017;208:103–8 | Population | Asymptomatic population |
Hezelgrave NL, Shennan AH. Quantitative fetal fibronectin to predict spontaneous preterm birth: a review. Womens Health 2016;12:121–8. https://doi | Population | Asymptomatic population |
Hezelgrave NL, Abbott DS, Radford SK, Seed PT, Girling JC, Filmer J, et al. Quantitative Fetal Fibronectin at 18 Weeks of Gestation to Predict Preterm Birth in Asymptomatic High-Risk Women. Obstet Gynecol 2016;127:255–63. https://doi | Population | Asymptomatic population |
Jwala S, Tran TL, Terenna C, McGregor A, Andrel J, Leiby BE, et al. Evaluation of additive effect of quantitative fetal fibronectin to cervical length for prediction of spontaneous preterm birth among asymptomatic low-risk women. Acta Obstet Gynecol Scand 2016;95:948–55. https://doi | Population | Asymptomatic population |
Kuhrt K, Hezelgrave N, Foster C, Seed PT, Shennan AH. Development and validation of a tool incorporating quantitative fetal fibronectin to predict spontaneous preterm birth in symptomatic women. Ultrasound Obstet Gynecol 2016;47:210–16. https://doi | Comparator | Outcome at 14 days |
Kuhrt K, Smout E, Hezelgrave N, Seed PT, Carter J, Shennan AH. Development and validation of a tool incorporating cervical length and quantitative fetal fibronectin to predict spontaneous preterm birth in asymptomatic high-risk women. Ultrasound Obstet Gynecol 2016;47:104–9. https://doi | Population | Asymptomatic population |
Kuhrt K, Unwin C, Hezelgrave N, Seed P, Shennan A. Endocervical and high vaginal quantitative fetal fibronectin in predicting preterm birth. J Matern Fetal Neonatal Med 2014;27:1576–9. https://doi | Population | Asymptomatic population |
Kurtzman J, Chandiramani M, Briley A, Poston L, Das A, Shennan A. Quantitative fetal fibronectin screening in asymptomatic high-risk patients and the spectrum of risk for recurrent preterm delivery. Am J Obstet Gynecol 2009;200:263.e1–6. https://doi | Population | Asymptomatic population |
Lu GC, Goldenberg RL, Cliver SP, Kreaden US, Andrews WW. Vaginal fetal fibronectin levels and spontaneous preterm birth in symptomatic women. Obstet Gynecol 2001;97:225–8 | Study design | ELISA test |
McLaren JS, Hezelgrave NL, Ayubi H, Seed PT, Shennan AH. Prediction of spontaneous preterm birth using quantitative fetal fibronectin after recent sexual intercourse. Am J Obstet Gynecol 2015;212:89.e1–5. https://doi | Population | Asymptomatic population |
Min J, Watson HA, Hezelgrave NL, Seed PT, Shennan AH. Ability of a preterm surveillance clinic to triage risk of preterm birth: a prospective cohort study. Ultrasound Obstet Gynecol 2016;48:38–42. https://doi | Population | Asymptomatic population |
Ridout A, Carter J, Shennan A. Clinical utility of quantitative fetal fibronectin in preterm labour. BJOG 2016;123:1972. https://doi | Study design | Letter |
Ross GN, Ridout AE, Shennan AH. Optimal clinical risk prediction can be achieved by combining quantitative fetal fibronectin and cervical length, and avoiding thresholds. Acta Obstet Gynecol Scand 2016;95:956. https://doi | Study design | Letter |
Schindhelm RK, Hoogenberg J, de Vos MT, Tegelaers FP. Analytical performance of quantitative fetal fibronectin assay. Ultrasound Obstet Gynecol 2016;47:127. https://doi | Study design | Letter |
van der Krogt L, Hezelgrave NL, Seed PT, Shennan AH. Prediction of spontaneous preterm birth using fetal fibronectin in women with a low-lying placenta. J Matern Fetal Neonatal Med 2017;30:313–16. https://doi | Population | Asymptomatic population |
Vandermolen BI, Hezelgrave NL, Smout EM, Abbott DS, Seed PT, Shennan AH. Quantitative fetal fibronectin and cervical length to predict preterm birth in asymptomatic women with previous cervical surgery. Am J Obstet Gynecol 2016;215:480.e1–480.e10. https://doi | Population | Asymptomatic population |
Watson HA, Carter J, Seed PT, Tribe RM, Shennan AH. The QUIPP app: a safe alternative to a treat-all strategy for threatened preterm labour. Ultrasound Obstet Gynecol 2017;50:342–6 | Abstract | Use of telephone application |
Zhou MX, Zhou J, Bao Y, Chen YQ, Cai C. Evaluation of the ability of cervical length and fetal fibronectin measurement to predict preterm delivery in asymptomatic women with risk factors. J Matern Fetal Neonatal Med 2015;28:153–7. https://doi | Population | Asymptomatic population |
Parsagen Diagnostics Inc. (PartoSure) submitted citations
TABLE 30
Citation | Reason for exclusion | Further detail |
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Bolotskikh V, Borisova V. Combined value of placental alpha microglobulin-1 detection and cervical length via transvaginal ultrasound in the diagnosis of preterm labor in symptomatic patients. J Obstet Gynaecol Res 2017;43:1263–9. https://doi | Included | |
Echebiri NC, McDoom MM, Aalto M, Pullen J, Doyle NM. Placental alpha-microglobulin-1 and combined traditional diagnostic test: a cost–benefit analysis. Am J Obstet Gynecol 2014;123:3S-S | Population | Ruptured membranes |
Echebiri NC, McDoom MM, Pullen JA, Aalto MM, Patel NN, Doyle NM. Placental alpha-microglobulin-1 and combined traditional diagnostic test: a cost-benefit analysis. Am J Obstet Gynecol 2015;212:77.e1–10. https://doi | Population | Ruptured membranes |
Fatkullin I, Akhmetgaliev A, Matveeva E, Seeger S. Utilization of a novel biomarker test (PARTOSURE PAMG-1) to reduce the length of stay in patients with threatened preterm labor and a short cervix. J Matern Fetal Neonatal Med 2016;29(Suppl. 1):283 | Abstract | Not enough information |
Hadzi-Lega M, Maier JT, Helmer H, Hellmeyer L, Markova AD, Poposka A. Comparison of PAMG-1 and phIGFBP-1 tests for the prediction of preterm delivery in patients with preterm labor. Open J Obstet Gynecol 2017;7:358–68 | Included | |
Heverhagen A. Placental alpha microglobulin-1 in combination with transvaginal ultrasound for prediction of preterm birth. J Perinat Med 2015;43(Suppl. 1):240 | Abstract | Not enough information |
Konoplyannikov A, Lysyuk I, Sokolyan A, Pipia N, Apresyan S, Karasova A, et al. PAMG-1 biomarker test (PARTOSURE) in combination with transvaginal ultrasound for improved assessment of spontaneous preterm birth in patients with threatened preterm labor. J Matern Fetal Neonatal Med 2016;29(Suppl. 1):278 | Abstract | Not enough information |
Lotfi G, Faraz S, Al Swalhee N, Nasir R, Somini S, Abdeldayem R, et al. Evaluation of PAMG-1 for the prediction of preterm birth in patients symptomatic of preterm labour. J Perinat Med 2015;43(Suppl. 1):250 | Abstract | Not enough information |
Lou YY, Ajay B. Is PartoSure effective in assessing preterm birth? BJOG 2016;123(Suppl. 2):89 | Abstract | Not enough information |
Ravi M, Beljorie M, El Masry K. Evaluation of the quantitative fetal fibronectin test And PartoSure™ (placental alpha microglobulin-1 [PAMG-1]) for the prediction of spontaneous preterm birth (SPTB) in patients with signs and symptoms suggestive of preterm labor. Journal of Pediatric and Neonatal Individualized Medicine 2017;6:ABS50 | Abstract | Not enough information |
Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery. J Perinat Med 2014;42:473–7. https://doi | Included | |
Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Comparison of a novel test for placental alpha microglobulin-1 with fetal fibronectin and cervical length measurement for the prediction of imminent spontaneous preterm delivery in patients with threatened preterm labor. J Perinat Med 2015;43:395–402. https://doi | Included | |
Nikolova T, Uotila J, Nikolova N, Borisova VY, Bolotskikh VM. 16: Do PAMG-1 or phIGFBP-1 biomarkers improve the prediction of imminent spontaneous preterm delivery in PTL symptomatic women with non-obvious cervical length (CL)? Am J Obstet Gynecol 2017;216:S11–12 | Abstract | Not enough information |
Melchor JC, Navas H, Marcos M, Iza A, de Diego M, Rando D, Burgos J. Retrospective Analysis on the Efficacy of the PAMG-1 Test and the Fetal Fibronectin Test in Assessing Preterm Birth in Symptomatic Women Attending an Emergency Obstetric Unit. Conference: 1st World Congress on Maternal Fetal Neonatal Medicine. London, April 2017 | Abstract | Not enough information |
Van Holsbeke C, Dam K, Staelens A, Mesens T, Corremans A. Comparison of the fetal fibronectin (Rapid fFN) and placental alpha microglobulin-1 (PartoSure) tests for predicting imminent spontaneous preterm birth. Ultrasound Obstet Gynecol 2016;48:84 | Abstract | Not enough information |
Wing D, Haeri S, Silber A, Roth C, Echebiri N, Franco A, Pappas L, et al. PAMG-1 (PARTOSURE™) vs. fFN to Assess Risk of Preterm Delivery in Symptomatic Women. Conference: KU Medical Centre/UC Irvine Health Institute. PartoSure GA Analysis | Abstract | Not enough information |
Studies excluded at full-text review, with reasons
TABLE 31
Citation | Reason for exclusion |
---|---|
Caroline VH, Annick C. Comparison of the fetal fibronectin (rapid FFN) and placental alpha microglobulin-1 (partosure) tests for predicting imminent spontaneous preterm birth in patients with threatened preterm labor. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Desjardins PR, Dansereau J, Hoag GN. Comparing the clinical effectiveness of Fetal Fibronectin and IGFBP-1 measurements in cervico-vaginal secretions, in predicting preterm deliveries. Clinical Chemistry 2008;54:A39–40 | Abstract |
Ehsanipoor RM, Swank M, Jwa SC, Wing DA, Tarabulsi G, Blakemore KJ. Placental alpha-microglobulin-1 in vaginal secretions as a predictor of preterm birth in women with evidence of preterm labor. Reprod Sci 2014;1:155A | Abstract |
Fatkullin I, Akhmetgaliev A, Matveeva E, Seeger S. Utilization of a novel biomarker test (PARTOSURE PAMG-1) to reduce the length of stay in patients with threatened preterm labor and a short cervix. J Matern Fetal Neonatal Med 2016;29:283 | Abstract |
Grobman W, Welshman E, Calhoun E. Does fetal fibronectin use in the diagnosis of preterm labor affect physician behavior and health care costs? A randomized trial. Am J Obstet Gynecol 2002;187(Suppl. 6):S80 | Abstract |
Grobman WA, Welshman EE, Calhoun EA, Ramsey PS. Fetal fibronectin results did not reduce medical resource use for women with preterm uterine contractions. Evidence-based Obstetrics and Gynecology 2005;7:118–9 | Abstract |
Hansen W, Lowe M, Zimmerman B. Effect of the fetal fibronectin assay on preterm labor management. Am J Obstet Gynecol 2001;185(Suppl. 6):S136. URL: http: | Abstract |
Heverhagen A. Placental alphamicroglobulin-1 in combination with transvaginal ultrasound for prediction of preterm birth. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Heverhagen A, Baumann M, Raio L, Surbek D. Placental alpha-microglobulin-1 in combination with transvaginal ultrasound for prediction of preterm birth. Am J Obstet Gynecol 2015;212(Suppl. 1):S81 | Abstract |
Heverhagen A, Muller M, Schleussner E, Deruelle P, Raio L, Surbek D. The prediction of preterm birth using placental alpha-microglobulin-1 in combination with transvaginal ultrasound. Reprod Sci 2016;1:131A–2A | Abstract |
Hillman-Cooper C, Ghag K, Dempsey A, Denbow M, Lopez Bernal A. Actim Partus-the first year at St. Michael’s Hospital, Bristol. Arch Dis Child Fetal Neonatal Ed 2014;99:A158–9 | Abstract |
Holmgren C, Lacoursiere DY, Esplin MS. Clinical predictors of a false negative fetal fibronectin (FFN). Am J Obstet Gynecol 2007;197:S204-S | Abstract |
Kang JH, Lee SE, Park C-W, Jun JK, Romero R, Yoon BH. Cervical fetal fibronectin: An index of intra-amniotic inflammation, histologic chorioamnionitis and impending preterm delivery in patients with preterm labor and intact membranes. Am J Obstet Gynecol 2007;197(Suppl. 6):S47 | Abstract |
Karunakaran B, Berry J, Parasuraman R. Can we raise the threshold for negative fetal fibronectin result? Arch Dis Child Fetal Neonatal Ed 2012;97:A89 | Abstract |
Konoplyannikov A, Lysyuk I, Sokolyan A, Pipia N, Apresyan S, Karasova A. PAMG-1 biomarker test (PARTOSURE) in combination with transvaginal ultrasound for improved assessment of spontaneous preterm birth in patients with threatened preterm labor. J Matern Fetal Neonatal Med Conference: 25th European Congress of Perinatal Medicine, the Netherlands 2016;29:278. URL: http: | Abstract |
Kuhnert M. Individual management of preterm labour by using rapid fetal fibronectintesta. J Matern Fetal Neonatal Med 2014;27:392–3 | Abstract |
Kung RWK, Northridge R, Nicoll AE. Fetal fibronectin (FFN) and iatrogenic pre-term birth. Arch Dis Child Fetal Neonatal Ed 2012;97:A80–1 | Abstract |
Lawin-O’Brien A, Jesner O, Biswas C. Evaluation of fetal fibronectin testing, subsequent management and outcomes in a London teaching hospital. Arch Dis Child Fetal Neonatal Ed 2014;99:A119 | Abstract |
Lega MH. Prediction of preterm delivery in patients in preterm labor. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Lotfi G, Faraz S, Al Swalhee N, Nasir R, Somini S, Abdeldayem R, et al. Evaluation of PAMG-1 for the prediction of preterm birth in patients symptomatic of preterm labor. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Lou YY, Ajay B. Is PartoSure effective in assessing preterm birth? BJOG 2016;123:89 | Abstract |
Mahavarker S, Osman MW, Ten-Hof J. Phosphorylated insulin-like growth factor binding protein-1 (ACTIM PARTUS) testing in management of threatened preterm labour. Arch Dis Child Fetal Neonatal Ed 2012;97:A99–100 | Abstract |
Nikolova N, Nikolova T, Jovchevski S, Micevska M. Phosphorylated insulin-like growth factor binding protein-1 in the prediction of preterm delivery in patients with preterm labor. J Matern Fetal Neonatal Med 2016;29:56 | Abstract |
Nikolova N, Nikolova T, Jovchevski S, Micevska M, Nikolovski S. A comparison between the phosphorylated insulin-like growth factor binding protein-1 and the cervical length in prediction of sampling to delivery time in patients with preterm labor. J Matern Fetal Neonatal Med 2016;29:56 | Abstract |
Nikolova T, Uotila J, Nikolova N, Borisova V, Bolotskikh V. Do PAMG-1 or phIGFBP-1 biomarkers improve the prediction of imminent spontaneous preterm delivery in PTL symptomatic women with non-obvious cervical length (CL)? Am J Obstet Gynecol Conference: 37th annual meeting of the society for maternal-fetal medicine: the pregnancy meeting United States 2017;216(Suppl. 1):S11–2. URL: http: | Abstract |
Northridge R, Liu H, Youssef R, Nicoll AE. Predicting pre-term birth using fetal fibronectin (FFN) in Ninewells Hospital, Dundee. Arch Dis Child Fetal Neonatal Ed 2011;96:Fa69 | Abstract |
Ponnusamy V, Farrer K. Impact of antenatal tests on acute in-utero transfers. Arch Dis Child Fetal Neonatal Ed 2012;97:A87 | Abstract |
Radford S, Costa F, Junior E, Sheehan P. Clinical application of quantitative fetal fibronectin for the prediction of preterm birth in symptomatic women. BJOG: Conference: RCOG World Congress 2016, UK 2016;123:158–9. URL: http: | Abstract |
Randhawa TS, Kwek K. Assessment of the predictive value of phosphorylated insulinlike growth factor binding protein-1 for preterm delivery. J Matern Fetal Neonatal Med 2010;23:294 | Abstract |
Spyroulis C, Tsitlakidis C. Prospective study of the Actim Partus test to predict preterm delivery between 24–34 weeks of gestation in Glan Clwyd Hospital. Period of study between August 2014–February 2015. BJOG 2016;123:8 | Abstract |
Thandayathany V, Yassin MAJM, Omar MH, Ismail NAM, Tamil AM, Kampan NC. Fetal fibronectin rapid test versus phosphorylated insulin-like growth factor-1 (phIGFBP-1) as bedside test kits for prediction of preterm delivery in the clinical setting. BJOG 2012;119:5 | Abstract |
Van Holsbeke C, Dam K, Staelens A, Mesens T, Corremans A. OP11.04: Comparison of the fetal fibronectin (Rapid fFN) and placental alpha microglobulin-1 (PartoSure) tests for predicting imminent spontaneous preterm birth. Ultrasound Obstet Gynecol 2016;48:84 | Abstract |
Sophie W, Tiphaine B, Celine C, Aurelie DB. Preterm labor: Reliability of the partosure test before and after digital and transvaginal ultrasound examinations. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Bare T, Mitre A, Shahinaj R, Bakiri F. Fetal fibronectin and cericometry in patients at increased risk for premature birth. J Perinat Med Conference: 12th World Congress of Perinatal Medicine 2015;43(no pagination) | Abstract |
Benson J, Ghidini A, Landy H, Gilo N, Drassinower D, Poggi S. Fetal fibronectin for evaluation of preterm labor in the setting of cervical cerclage. Am J Obstet Gynecol 2009;201:S68–S9 | Abstract |
Berghella V, Hayes E, Visintine J, Baxter JK. Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database Syst Rev 2008;4:CD006843. https://doi | Abstract |
Burrus DR, Ernest JM, Veille JC. Efficacy of four markers of preterm labor (PTL) at predicting preterm delivery (PTD) in a population presenting with contractions and cervical change. Am J Obstet Gynecol 1995;172:405 | Abstract |
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Goepfert AR, Network NM. The preterm prediction study: Quantitative fetal fibronectin (FFN) values and the prediction of spontaneous preterm birth (SPTB). Am J Obstet Gynecol 1997;176:S52 | Abstract |
Goldenberg RL. Vaginal fetal fibronectin (V-fFN) levels at 8–22 weeks and subsequent spontaneous preterm birth (SPB). Am J Obstet Gynecol 2000;182:S32 | Abstract |
Greenhagen JB, Van Wagoner J, Dudley D, Hunter C, Mitchell M, Casal D, et al. The value of fetal fibronectin as a predictor of preterm delivery in low risk women. Am J Obstet Gynecol 1996;174:471 | Abstract |
Grover CM. Use of the fetal fibronectin assay to avert unnecessary hospitalization and bedrest in patients with preterm labor symptoms: a cost analysis. Prim Care Update Ob Gyns 1998;5:178–9 | Abstract |
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Hedriana HL, Bliss MC, Gilbert WM. Implementation of fetal fibronectin (FFN) testing in a large private practice hospital is safe and effective for the diagnosis and management of preterm labor (PTL). Am J Obstet Gynecol 2005;193:S52-S | Abstract |
Henrich W. Cervicometry and fibronectin role. J Matern Fetal Neonatal Med 2010;23:39 | Abstract |
Hillman-Cooper C, Denbow M, Lopez Bernal A. Identification and quantification of maternal plasma proteins that predict preterm labour. BJOG 2013;120:160–1 | Abstract |
Hillman-Cooper CS, Denbow M, Bernal AL. Identification and quantification of maternal plasma proteins that predict preterm labour. Endocrine Reviews Conference: 95th Annual Meeting and Expo of the Endocrine Society, ENDO 2013;34(Suppl. 1) | Abstract |
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Kay S, McKie L, Ajoku K, Roberts N. Fetal fibronectin testing in a district general hospital setting – Are we changing our management of women with symptomatic preterm labour? BJOG 2015;122:186 | Abstract |
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Kuhrt K, Seed P, Smout E, Hezelgrave N, Shennan A. The development and validation of a new tool to predict spontaneous preterm birth in high-risk women using quantitative fetal fibronectin and cervical length. BJOG 2013;120:14–15 | Abstract |
Kurtzman J, Chandiramani M, Riley A, Poston L, Das A, Shennan A. Quantitative fetal fibronectin screening at 24 weeks delineates the risk of spontaneous preterm delivery in asymptomatic patients with a prior history of preterm premature rupture of membranes (PPROM). Am J Obstet Gynecol 2009;1:S227 | Abstract |
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Morrison JC, Naefi RWI, Botti JJ, Katz M, Belluomini JM. Uterine activity and fetal fibronectin are independent and combined predictors of spontaneous preterm birth. Am J Obstet Gynecol 1995;172:406 | Abstract |
Muller A, McCullough M, Obican S, Norton H, Carter J, Gonzalez-Quintero VH. ‘false’ positive fetal fibronectin and rates of adverse obstetrical outcomes. Am J Obstet Gynecol 2006;195:S233-S | Abstract |
Muzaffar S, Behrens R, Barns F, Walker S. Quantitative fetal fibronectin and preterm delivery. BJOG 2013;120:595–6 | Abstract |
Myint H, Singh V, Roberts NJ. Introducing fetal fibronectin testing to a District General Hospital in women with symptoms of preterm labour. Arch Dis Child Fetal Neonatal Ed 2011;96:Fa83 | Abstract |
Myint HH, Ciopec A, Roberts N, Sinha P. Use of fetal fibronectin testing in a district general hospital in women with symptoms of preterm labour. BJOG 2013;120:41–2 | Abstract |
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Radford S, Abbott D, Seed P, Kemp J, Shennan A. Quantitative fetal fibronectin for the prediction of preterm birth in symptomatic women. Arch Dis Child Fetal Neonatal Ed 2012;97:A73 | Abstract |
Radford S, Smith J, Shennan A, Wallace EM. Interhospital transfers of women in threatened preterm labour to Victorian level 6 hospitals. J Paediatr Child Health 2015;51:51 | Abstract |
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Salari K, Treadwell M, Thompson K. Predictors of preterm birth: a comparison of cervical length, fetal fibronectin and fetal adrenal gland enlargement. Am J Obstet Gynecol 2015;212:S179–80 | Abstract |
Sasson I, Triche EW, Azpurua H, Romano M, Paidas M. Short cervix and negative fetal fibronectin: low risk of delivery within 2 weeks of screening. Am J Obstet Gynecol 2008;199:S49-S | Abstract |
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Simhan H. Comparison of self-collected vs speculum-collected measurement of quantitative fetal fibronectin. Am J Obstet Gynecol 2016;214:S310–1 | Abstract |
Stern V, Amabebe E, Anumba D. The association between cervicovaginal fetal fibronectin, the metabolic markers of the vaginal microbiome, and preterm birth. BJOG 2016;123:79–80 | Abstract |
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Stern V, Anumba DOC. Predicting preterm birth – the performance of ultrasound cervical length, quantitative fetal fibronectin and vaginal fluid pH differs by risk of preterm birth and symptoms of preterm labour. Reprod Sci 2016;23:106A-A | Abstract |
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Swancoat S. ‘Recent vaginal exam’ no longer a contraindication to fetal fibronectin sampling: A prospective study. Obstetrics and Gynecology 2016;127:16S-S | Abstract |
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van Baaren GJ, Bruijn M, Vis J, Wilms F, Oudijk M, Kwee A, et al. False-positive, false-negative and uninterpretable results in fetal fibronectin testing during the APOSTEL1 study; which factors do contribute? Am J Obstet Gynecol 2014;210:S395-S | Abstract |
van der Krogt L, Hezelgrave N, Seed P, Shennan A. Prediction of spontaneous preterm birth using fetal fibronectin in women with a low-lying placenta. BJOG 2016;123:85 | Abstract |
Vanner T, Rooney M, Blackburn S. Trends in In-utero transfer: Royal Wolverhampton Hospitals NHS Trust 2007 to 2010. Arch Dis Child Fetal Neonatal Ed 2011;96:Fa38 | Abstract |
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Raw rest accuracy data as reported in the papers
TABLE 32
Study (first author and year) | N | True positive | False positive | True negative | False negative | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | +LR (95% CI) | –LR (95% CI) |
---|---|---|---|---|---|---|---|---|---|---|---|
Actim Partus | |||||||||||
Brik (2010)48 | 276 | NR | NR | NR | NR | 73.7 | 64.9 | 16.1 | 96.4 | 2.10 (1.52 to 2.91) | 0.41 (0.19 to 0.87) |
Goyal (2016)52 | 60 | 23 | 11 | 14 | 12 | NR | NR | NR | NR | NR | NR |
Lembet (2002)53 | 36 | 14 | 4 | 17 | 1 | 93.3 | 81 | 77.8 | 94.4 | 4.9 (2.0 to 11.9) | 0.08 (0.01 to 0.50) |
Ting (2007)56 | 94 | NR | NR | NR | NR | 100 | 74 | 18 | 100 | NR | NR |
Tripathi (2016)57 | 468 | NR | NR | NR | NR | 95.4 | 82.2 | 61.7 | 98.3 | NR | NR |
aVishwekar (2017)58 | 30 | 11 | 3 | 14 | 2 | 73.3 | 64.3 | 68.8 | 69.2 | NR | NR |
PartoSure | |||||||||||
Werlen (2015)41 | 41 | 0 | 1 | 39 | 1 | NR | NR | NR | NR | NR | NR |
NR, not reported.
- a
One patient with a negative result absconded so delivery details could not be obtained.
TABLE 33
Study (first author and year) and test | N | True positive | False positive | True negative | False negative | Sensitivity, n/N (%) [95% CI] | Specificity, n/N (%) [95% CI] | PPV, n/N (%) [95% CI] | NPV, n/N (%) [95% CI] | +LR (95% CI) | –LR (95% CI) |
---|---|---|---|---|---|---|---|---|---|---|---|
Bruijn (2016) (APOSTEL-1)42,43 | |||||||||||
fFN at < 10 ng/ml | 350 | 66 | 162 | 119 | 3 | NR | NR | NR | NR | NR | NR |
fFN at < 200 ng/ml | 49 | 46 | 235 | 20 | NR | NR | NR | NR | NR | NR | |
fFN at < 500 ng/ml | 29 | 12 | 269 | 40 | NR | NR | NR | NR | NR | NR | |
Actim Partus | 54 | 30 | 251 | 15 | (78.3) | (89.3) | (64.3) | (94.4) | NR | NR | |
Hadzi-Lega (2017)44 | |||||||||||
Actim Partus | 57 | 5 | 12 | 39 | 1 | 5/6 (83) [35.88 to 99.58] | 39/51 (76) [62.51 to 87.21] | 5/17 (29) [10.31 to 55.96] | 39/40 (98) [86.84 to 99.94] | NR | NR |
PartoSure | 5 | 5 | 46 | 1 | 5/6 (83) [35.88 to 99.58] | 46/51 (90) [78.59 to 96.74] | 5/10 (50) [18.71 to 81.29] | 46/47 (98) [88.71 to 99.95] | NR | NR | |
Abo El-Ezz (2014)45 | |||||||||||
Actim Partus | 57 | 20 | 9 | 18 | 10 | NR | NR | NR | NR | NR | NR |
Altinkaya (2009)46 | |||||||||||
Actim Partus | 105 | 9 | 16 | 75 | 5 | NR | NR | NR | NR | NR | NR |
Azlin (2010)47 | |||||||||||
Actim Partus | 51 | 4 | 3 | 43 | 1 | (80.0) | (93.5) | (57.1) | (97.7) | NR | NR |
Brik (2010)48 | |||||||||||
Actim Partus | 276 | NR | NR | NR | NR | 73.1 | 66.2 | 21.8 | 95 | 2.16 [1.60 to 2.92] | 0.41 [0.21 to 0.78] |
Cooper (2012)49 | |||||||||||
Actim Partus | 349 | 2 | 89 | 254 | 4 | 2/6 (33) [0.00 to 0.71] | 254/343 (74) [0.69 to 0.79] | 2/91 (2) [0.00 to 0.05] | 254/258 (98) [0.97 to 1.00] | 1.28 [0.41 to 4.04] | 0.90 [0.51 to 1.59] |
Danti (2011)50 | |||||||||||
Actim Partus | 60 | 2 | 17 | 39 | 2 | (50) [7 to 93] | (70) [56 to 81] | (11) [1 to 33] | (95) [83 to 99] | 1.65 [0.57 to 4.74] | 0.72 [0.27 to 1.94] |
Eroglu (2007)51 | |||||||||||
Actim Partus | 51 | 5 | 7 | 38 | 1 | (83.3) | (84.4) | (41.7) | (97.4) | 5.36 [2.3 to 12.2] | 0.20 [0.01 to 0.7] |
Goyal (2016)52 | |||||||||||
Actim Partus | 60 | 26 | 8 | 8 | 18 | NR | NR | NR | NR | NR | NR |
Lembet (2002)53 | |||||||||||
Actim Partus | 36 | 15 | 3 | 17 | 1 | (93.8) | (85) | (83.3) | (94.1) | 6.2 [2.2 to 17.8] | 0.07 [0.01 to 0.5] |
Riboni (2011)54 | |||||||||||
Actim Partus | 210 | NR | NR | NR | NR | (50) | (83.7) | (10.8) | (97.7) | NR | NR |
aTanir (2009)55 | |||||||||||
Actim Partus | 68 | 14 | 11 | 42 | 1 | 14/15 (93.3) | 42/53 (79.2) | 14/25 (56) | 42/43 (97.6) | 4.4 [2.1 to 5.2] | 0.8 [0.4 to 0.9] |
Ting (2007)56 | |||||||||||
Actim Partus | 94 | NR | NR | NR | NR | (69) | (78) | (39) | (92) | NR | NR |
Tripathi (2016)57 | |||||||||||
Actim Partus | 468 | NR | NR | NR | NR | (94.7) | (92.4) | (85.6) | (97.3) | NR | NR |
bVishwekar (2017)58 | |||||||||||
Actim Partus | 30 | 13 | 1 | 10 | 5 | (68.4) | (90) | (92.9) | (60) | NR | NR |
Bolotskikh (2017)59 | |||||||||||
PartoSure | 99 | 12 | 4 | 83 | 0 | 12/12 (100) [74 to 100] | 83/87 (95) [89 to 99] | 12/16 (75) [48 to 93] | 83/83 (100) [96 to 100] | NR | NR |
Nikolova (2015)61 | |||||||||||
PartoSure | 203 | 28 | 9 | 159 | 7 | 28/35 (80) [63.1 to 91.6] | 159/168 (95) [90.1 to 97.5] | 28/37 (76) [58.8 to 88.2] | 159/166 (96) [91.5 to 98.3] | NR | NR |
Werlen (2015)41 | |||||||||||
PartoSure | 41 | 0 | 1 | 39 | 1 | (0) [0.0 to 9.75] | (97.5) [86.8 to 99.9] | (0) [0.0 to 97.5] | (97.5) [86.8 to 99.9] | NR | NR |
Bruijn (2016) (Bruijn)62 | |||||||||||
fFN at < 10 ng/ml | 455 | 45 | 276 | 131 | 3 | NR | NR | NR | NR | NR | NR |
fFN at < 200 ng/ml | 455 | 34 | 87 | 320 | 14 | NR | NR | NR | NR | NR | NR |
fFN at < 500 ng/ml | 455 | 14 | 23 | 384 | 34 | NR | NR | NR | NR | NR | NR |
NR, not reported.
- a
‘When there were no visible lines, which was observed in two cases, a new sample was not taken. These patients were assigned test positive.’
- b
One patient with a negative result absconded so delivery details could not be obtained.
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