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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.)

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Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation.

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Appendix 3Supplementary citations and data

Included 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

Included citations

ReferenceFull 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;44:525–30FT
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​.org/10.1007​/s00404-008-0703-7FT
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​.org/10.3109/01443615​.2010.489162FT
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;23:100Ab
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​.org/10.1111/jog.13366FT
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​.org/10.3109​/00016340903443668FT
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):S190–1Ab
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:S191–2Ab
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):S364Ab
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):S363–4Ab
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​.org/10.1111/1471-0528.13752FT
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.e8FT
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;206:220–4FT
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​.org/10.1038/jp.2011.133FT
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​.org/10.3109/14767058​.2010.547962FT
Eroglu D, Yanik F, Oktem M, Zeyneloglu HB, Kuscu E. Prediction of preterm delivery among women with threatened preterm labor. Gynecol Obstet Invest 2007;64:109–16FT
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​.org/10.1016/j​.ijgo.2016.01.019FT
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;48:345–6Ab
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;29:55Ab
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;7:11FT
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):S147Ab
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;81:706–12FT
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; 2013Ab
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​.org/10.1515/jpm-2013-0234FT
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​.org/10.1515/jpm-2014-0300FT
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​.org/10.1007​/s00404-011-1839-4FT
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​.org/10.1111/j​.1447-0756.2008.00833.xFT
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;36:399–402FT
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​.org/10.1016/j​.ijgo.2016.03.030FT
Vishwekar PS, Chauhan AR, Turakhia N. Prediction of preterm delivery with a novel bedside test. Int J Reprod Contracept Obstet Gynecol 2017;6:3366–71FT
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​.org/10.1016/j​.gyobfe.2015.07.002FT

Ab, abstract; FT, full text.

Alere Inc. (Actim Partus) submitted citations

TABLE 28

Alere Inc. (Actim Partus) submitted citations

CitationReason for exclusionFurther 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​.org/10.3109/01443615​.2010.494203PopulationTwin 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;49:368–72ComparatorOutcome 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​.org/10.1007​/s00404-008-0703-7Included
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​.org/10.3109/01443615​.2010.489162Included
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​.org/10.1080​/14767050802037613PopulationAsymptomatic 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​.org/10.1002/uog.3989PopulationAsymptomatic 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​.org/10.3109​/00016340903443668Included
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;206:220–4Included
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​.org/10.1038/jp.2011.133Included
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​.org/10.3109/14767058​.2010.547962Included
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​.org/10.1111/j​.1600-0412.2010.01018.xPopulationPost-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​.org/10.1055/s-2005-870895PopulationNot 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;64:109–16Included
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​.org/10.1515/jpm-2014-0275ComparatorOutcome 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;80:546–51OutcomeUnclear 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;353:1494Study designLetter
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​.org/10.3109/01443615​.2011.637649PopulationAsymptomatic
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​.org/10.1007​/s00404-014-3577-xPopulationPost-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;33:780–3PopulationUnclear 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;5:121–4OutcomeUnclear 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;81:706–12Included
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​.org/10.17392/856-16PopulationAsymptomatic 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;94:243–9PopulationTerm 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;46:1378–83Language
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;86:151–5OutcomeOutcome at 34 weeks
Rahkonen L. Prediction of pre-term delivery with phosphorylated insulin-like growth factor-binding protein-1. Eur J Obstet Gynecol 2011;6:3–7Study designReview
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​.org/10.1007​/s00404-011-1839-4Included
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​.org/10.1007​/s00404-011-1915-9PopulationAsymptomatic
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;35:394–400PopulationAsymptomatic
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;44:2250–6Language
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​.org/10.1111/j​.1447-0756.2008.00833.xIncluded
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;36:399–402Included
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​.org/10.1016/j​.ijgo.2016.03.030Included
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​.org/10.1111/1471-0528.14175PopulationTerm women, labour induction

Hologic, Inc. (fFN) submitted citations

TABLE 29

Hologic, Inc. (fFN) submitted citations

CitationReason for exclusionFurther detail
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​.org/10.3109/01443615​.2013.772129Study designCase 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​.org/10.1097/AOG​.0000000000000754PopulationAsymptomatic 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​.org/10.1016/j​.ajog.2012.10.890ComparatorOutcome 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​.org/10.3109/01443615​.2015.1006597Study designCase 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​.org/10.1016/j​.ejogrb.2009.06.021ComparatorOutcome 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​.org/10.3109/14767058​.2010.535872PopulationAsymptomatic 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​.org/10.1016/j​.ejogrb.2012.06.012PopulationTriplet 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​.org/10.1111/1471-0528.13752Included
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.e8Included
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​.org/10.1515/jpm-2015-0414ComparatorOutcome 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​.org/10.1016/j​.ejogrb.2016.05.046ComparatorOutcome 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​.org/10.2217/bmm.14.28Study designLiterature 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​.org/10.3109/01443615​.2013.834309Study designCase 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;183:1480–3PopulationAsymptomatic 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;88:233–8PopulationAsymptomatic 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;183:469–75PopulationAsymptomatic 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;87:643–8PopulationAsymptomatic 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​.org/10.1515/jpm-2015-0270OutcomeDoes 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;208:103–8PopulationAsymptomatic population
Hezelgrave NL, Shennan AH. Quantitative fetal fibronectin to predict spontaneous preterm birth: a review. Womens Health 2016;12:121–8. https://doi​.org/10.2217/whe.15.74PopulationAsymptomatic 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​.org/10.1097/AOG​.0000000000001240PopulationAsymptomatic 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​.org/10.1111/aogs.12907PopulationAsymptomatic 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​.org/10.1002/uog.14894ComparatorOutcome 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​.org/10.1002/uog.14865PopulationAsymptomatic 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​.org/10.3109/14767058​.2013.870550PopulationAsymptomatic 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​.org/10.1016/j​.ajog.2009.01.018PopulationAsymptomatic 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;97:225–8Study designELISA 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​.org/10.1016/j​.ajog.2014.06.055PopulationAsymptomatic 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​.org/10.1002/uog.15925PopulationAsymptomatic population
Ridout A, Carter J, Shennan A. Clinical utility of quantitative fetal fibronectin in preterm labour. BJOG 2016;123:1972. https://doi​.org/10.1111/1471-0528.13850Study designLetter
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​.org/10.1111/aogs.12922Study designLetter
Schindhelm RK, Hoogenberg J, de Vos MT, Tegelaers FP. Analytical performance of quantitative fetal fibronectin assay. Ultrasound Obstet Gynecol 2016;47:127. https://doi​.org/10.1002/uog.15824Study designLetter
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​.org/10.3109/14767058​.2016.1171837PopulationAsymptomatic 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​.org/10.1016/j​.ajog.2016.05.020PopulationAsymptomatic 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;50:342–6AbstractUse 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​.org/10.3109/14767058​.2014.909801PopulationAsymptomatic population

Parsagen Diagnostics Inc. (PartoSure) submitted citations

TABLE 30

Parsagen Diagnostics Inc. (PartoSure) submitted citations

CitationReason for exclusionFurther detail
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​.org/10.1111/jog.13366Included
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-SPopulationRuptured 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​.org/10.1016/j​.ajog.2014.07.028PopulationRuptured 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):283AbstractNot 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;7:358–68Included
Heverhagen A. Placental alpha microglobulin-1 in combination with transvaginal ultrasound for prediction of preterm birth. J Perinat Med 2015;43(Suppl. 1):240AbstractNot 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):278AbstractNot 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):250AbstractNot enough information
Lou YY, Ajay B. Is PartoSure effective in assessing preterm birth? BJOG 2016;123(Suppl. 2):89AbstractNot 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:ABS50AbstractNot 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​.org/10.1515/jpm-2013-0234Included
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​.org/10.1515/jpm-2014-0300Included
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:S11–12AbstractNot 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 2017AbstractNot 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;48:84AbstractNot 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 AnalysisAbstractNot enough information

Studies excluded at full-text review, with reasons

TABLE 31

Studies excluded at full-text review, with reasons

CitationReason 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:A39–40Abstract
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;1:155AAbstract
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;29:283Abstract
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):S80Abstract
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;7:118–9Abstract
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:​//onlinelibrary​.wiley.com/o/cochrane​/clcentral/articles​/596/CN-00387596/frame.html (accessed September 2017)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):S81Abstract
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–2AAbstract
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:A158–9Abstract
Holmgren C, Lacoursiere DY, Esplin MS. Clinical predictors of a false negative fetal fibronectin (FFN). Am J Obstet Gynecol 2007;197:S204-SAbstract
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):S47Abstract
Karunakaran B, Berry J, Parasuraman R. Can we raise the threshold for negative fetal fibronectin result? Arch Dis Child Fetal Neonatal Ed 2012;97:A89Abstract
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:​//onlinelibrary​.wiley.com/o/cochrane​/clcentral/articles​/387/CN-01214387/frame.html (accessed September 2017)Abstract
Kuhnert M. Individual management of preterm labour by using rapid fetal fibronectintesta. J Matern Fetal Neonatal Med 2014;27:392–3Abstract
Kung RWK, Northridge R, Nicoll AE. Fetal fibronectin (FFN) and iatrogenic pre-term birth. Arch Dis Child Fetal Neonatal Ed 2012;97:A80–1Abstract
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:A119Abstract
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;123:89Abstract
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:A99–100Abstract
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;29:56Abstract
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;29:56Abstract
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:​//onlinelibrary​.wiley.com/o/cochrane​/clcentral/articles​/156/CN-01304156/frame.html (accessed September 2017)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:Fa69Abstract
Ponnusamy V, Farrer K. Impact of antenatal tests on acute in-utero transfers. Arch Dis Child Fetal Neonatal Ed 2012;97:A87Abstract
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:​//onlinelibrary​.wiley.com/o/cochrane​/clcentral/articles​/043/CN-01179043/frame.html (accessed September 2017)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;23:294Abstract
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;123:8Abstract
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;119:5Abstract
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;48:84Abstract
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–S9Abstract
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​.org/10.1002/14651858​.CD006843.pub2Abstract
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;172:405Abstract
Burrus DR, Ernest JM, Veille JC. Efficacy of four markers of preterm labor (PTL) at predicting latency (LAT) in a population receiving tocolytic therapy. Am J Obstet Gynecol 1995;172:405Abstract
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:S52Abstract
Goldenberg RL. Vaginal fetal fibronectin (V-fFN) levels at 8–22 weeks and subsequent spontaneous preterm birth (SPB). Am J Obstet Gynecol 2000;182:S32Abstract
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;174:471Abstract
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;5:178–9Abstract
Hadzi-Lega M, Daneva Markova A, Micevska M, Atanasovska Bosku A, Gjirevski V. Cervical length and phosphorilated insulin like growth factor binding protein-1 as a predictors of spontaneus preterm delivery in symptomatic women. J Matern Fetal Neonatal Med 2014;27:399Abstract
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-SAbstract
Henrich W. Cervicometry and fibronectin role. J Matern Fetal Neonatal Med 2010;23:39Abstract
Hillman-Cooper C, Denbow M, Lopez Bernal A. Identification and quantification of maternal plasma proteins that predict preterm labour. BJOG 2013;120:160–1Abstract
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
Hong J-S, Yoon BH, Romero R, Shim S-S, Sohn Y-K, Park C-W, et al. Patients with a positive cervical fetal fibronectin followed by a negative test have a reduced likelihood of spontaneous preterm delivery. Am J Obstet Gynecol 2003;189(Suppl. 6):S173Abstract
Iriye B, Hancock J, Wold S, Huang W, Gorski L, Hancock L. Fetal fibronectin (fFN) testing in symptomatic patients for preterm labor and McDonald cerclage. Am J Obstet Gynecol 2004;191:S111-SAbstract
Joffe G. The use & cost benefit of fetal fibronectin testing in an integrated health care system. Clinical Chemistry 1999;45:S32–S3Abstract
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;122:186Abstract
Khizar SBK, Vallabu S. How to introduce a new service in clinical practice. BJOG 2013;120:96Abstract
Kiefer D, Keeler S, Rust O, Demishev M, Muscat J, Bornstein E, et al. Is fetal fibronectin (FFN) a marker of intra-amniotic inflammation in patients with midtrimester short cervix? Am J Obstet Gynecol 2009;201:S60-SAbstract
Knee A, Belisle E, Markenson G, Malshe A, Plevyak M, Bsat F, et al. Do pregnancies complicated by preterm births with a negative fetal fibronectin screen have different characteristics compared to those that have positive fibronectin results? Am J Obstet Gynecol 2011;204:S190-SAbstract
Knight B, Smith H, Tregarthen A, Lapointe J, Shennan A, Taylor MJO, et al. Quantitative fetal fibronectin as a predictor of time to delivery in women undergoing induction of labour: a pilot study. BJOG 2016;123:E5-EAbstract
Kreaden U, Sheldon L, Lockhart T, Paulson M, Shorter S, Martinez R, et al. Natural distribution of fetal fibronectin (fFN) among symptomatic and asymptomatic pregnant women. Clinical Chemistry 1999;45:A86–7Abstract
Krems J, McGregor J, Hastings C, Hanson J. Fetal fibronectin in cervical secretions: An aid for predicting delivery in women at high risk from preterm delivery. Am J Obstet Gynecol 1995;172:406Abstract
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;120:14–15Abstract
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:S227Abstract
Kurtzman J, Jimenez-Solis G, Rosalesortiz S, Martinez-Alvarez O, Das A, Antonio AMJ. Cervical length significantly modifies the risk of preterm delivery in low risk patients with symptomatic preterm labor and a positive fetal fibronectin. Am J Obstet Gynecol 2008;199:S212-SAbstract
Levine LD, Romero JA, Pappas H, Weber AL, Elovitz MA. A prospective blinded cohort study evaluating fetal fibronectin and cervical length in predicting preterm birth in symptomatic women. Am J Obstet Gynecol 2016;214:S441–2Abstract
Luzzi V, Hankins K, Gronowski AM. Accuracy of the rapid fetal fibronectin TLi system in predicting preterm delivery. Clin Chem 2003;49:501–2Abstract
Maharajan P, Elliot J, Thampi P. Efficacy of fibronectin and its impact on the use of atosiban-cost implication. Arch Dis Child Fetal Neonatal Ed 2012;97:A92Abstract
Mancuso M, Biggio J, Owen J. Fetal fibronectin and latency period in women with arrested preterm labor. Am J Obstet Gynecol 2013;208:S221-SAbstract
Mateus J, Pereira L, Baxter J, Berghella V, Cheku B, Tolosa JE. Fetal fibronectin compared to cervical dilation in clinical practice. Am J Obstet Gynecol 2003;189:S165-SAbstract
McKenna DS, Chung K, Shubert P, Iams JD. The effect of digital examination on the expression of fetal fibronectin. Am J Obstet Gynecol 1998;178:S188Abstract
Merriam A, Sciscione A, Daniel L. A prospective evaluation of the effectiveness of vaginal fetal fibronectin to predict preterm birth in women with symptoms of preterm labor in the outpatient setting. Am J Obstet Gynecol 2014;210:S224-SAbstract
Mogami H, Kondo E, Fujita K, Chigusa Y, Nishimura F, Ujita M, et al. Fetal fibronectin is a pathogenic factor of preterm PROM and preterm birth. Placenta 2013;34:A4-AAbstract
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;172:406Abstract
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-SAbstract
Muzaffar S, Behrens R, Barns F, Walker S. Quantitative fetal fibronectin and preterm delivery. BJOG 2013;120:595–6Abstract
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:Fa83Abstract
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;120:41–2Abstract
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O’Byrne L, Daly S. Audit of fetal fibronectin use in a tertiary referral hospital in the triaging of threatened preterm labour. BJOG 2016;123:13–14Abstract
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Pradhan-Drews M, Drews F, Goddard R. Audit on preterm labour. BJOG 2013;120:431–2Abstract
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:A73Abstract
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;51:51Abstract
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Rebarber A, Sfakianaki AK, Kuczynski E, Paidas M, Russo K, Maturi J, et al. Fetal fibronectin is a valid predictor of spontaneous preterm delivery in patients with cervical cerclages. Am J Obstet Gynecol 2001;185(Suppl. 6):S128Abstract
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Raw rest accuracy data as reported in the papers

TABLE 32

The DTA values for prediction of delivery within 48 hours

Study (first author and year)NTrue positiveFalse positiveTrue negativeFalse negativeSensitivity (%)Specificity (%)PPV (%)NPV (%)+LR (95% CI)–LR (95% CI)
Actim Partus
Brik (2010)48276NRNRNRNR73.764.916.196.42.10 (1.52 to 2.91)0.41 (0.19 to 0.87)
Goyal (2016)526023111412NRNRNRNRNRNR
Lembet (2002)533614417193.38177.894.44.9 (2.0 to 11.9)0.08 (0.01 to 0.50)
Ting (2007)5694NRNRNRNR1007418100NRNR
Tripathi (2016)57468NRNRNRNR95.482.261.798.3NRNR
aVishwekar (2017)583011314273.364.368.869.2NRNR
PartoSure
Werlen (2015)414101391NRNRNRNRNRNR

NR, not reported.

a

One patient with a negative result absconded so delivery details could not be obtained.

TABLE 33

The DTA values for prediction of delivery within 7 days

Study (first author and year) and testNTrue positiveFalse positiveTrue negativeFalse negativeSensitivity, 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/ml350661621193NRNRNRNRNRNR
 fFN at < 200 ng/ml494623520NRNRNRNRNRNR
 fFN at < 500 ng/ml291226940NRNRNRNRNRNR
 Actim Partus543025115(78.3)(89.3)(64.3)(94.4)NRNR
Hadzi-Lega (2017)44
 Actim Partus575123915/6 (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]NRNR
 PartoSure554615/6 (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]NRNR
Abo El-Ezz (2014)45
 Actim Partus572091810NRNRNRNRNRNR
Altinkaya (2009)46
 Actim Partus105916755NRNRNRNRNRNR
Azlin (2010)47
 Actim Partus5143431(80.0)(93.5)(57.1)(97.7)NRNR
Brik (2010)48
 Actim Partus276NRNRNRNR73.166.221.8952.16 [1.60 to 2.92]0.41 [0.21 to 0.78]
Cooper (2012)49
 Actim Partus34928925442/6 (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 Partus60217392(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 Partus5157381(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 Partus60268818NRNRNRNRNRNR
Lembet (2002)53
 Actim Partus36153171(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 Partus210NRNRNRNR(50)(83.7)(10.8)(97.7)NRNR
aTanir (2009)55
 Actim Partus68141142114/15 (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 Partus94NRNRNRNR(69)(78)(39)(92)NRNR
Tripathi (2016)57
 Actim Partus468NRNRNRNR(94.7)(92.4)(85.6)(97.3)NRNR
bVishwekar (2017)58
 Actim Partus30131105(68.4)(90)(92.9)(60)NRNR
Bolotskikh (2017)59
 PartoSure9912483012/12 (100) [74 to 100]83/87 (95) [89 to 99]12/16 (75) [48 to 93]83/83 (100) [96 to 100]NRNR
Nikolova (2015)61
 PartoSure203289159728/35 (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]NRNR
Werlen (2015)41
 PartoSure4101391(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]NRNR
Bruijn (2016) (Bruijn)62
 fFN at < 10 ng/ml455452761313NRNRNRNRNRNR
 fFN at < 200 ng/ml455348732014NRNRNRNRNRNR
 fFN at < 500 ng/ml455142338434NRNRNRNRNRNR

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.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Varley-Campbell et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
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