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Does Assessment of Cervical Phosphorylated Insulin-like Growth Factor Binding Protein-1 by Bedside Vaginal Swab Test Really Predict Preterm Birth?

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Abstract

Preterm birth is the first cause of neonatal mortality and is associated with elevated risks of long-term complications such as neurodevelopmental impairment. Prediction of spontaneous preterm birth, one of the biggest challenges in obstetrics, aims at delaying birth in order to allow corticosteroid therapy and, if necessary, transfer of patient to a higher-level maternity care unit. We aimed to assess the predictive role of phIGFBP-1 (Actim® Partus) diagnostic test on patients at risk of preterm labor, routinely used in our institution. We conducted a retrospective cohort study on 99 patients admitted in the high-risk pregnancy unit of our institution from June 2012 to November 2014. The primary outcome measures were delivery before 34+0 and 37+0 weeks. Data analysis allowed measure of Actim® Partus test sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV), diagnostic efficiency as well as positive and negative likelihood ratios. Actim® Partus test features (Se, Sp, PPV and NPV) were 53.3, 67.9, 23.5 and 88.7% respectively for deliveries occurring ≤ 34+0 weeks and 54.2, 75.4, 55.8, and 74.2%, respectively, for deliveries occurring ≤ 37+0 weeks. Diagnostic efficiency of the test was 65.7% (≤ 34+0 weeks) and 67.7% (≤ 37+0 weeks). Positive likelihood ratios were 1.6 (≤ 34+0 weeks) and 2.2 (≤ 37+0 weeks). Negative likelihood ratios were 0.7 (≤ 34+0 weeks) and 0.6 (≤ 37+0 weeks). Results of our study show that phIGFBP-1 diagnostic test is not accurate enough in predicting preterm birth before 34+0 or 37+0 weeks, and therefore, there is little clinical interest in its everyday use.

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References

  1. Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012;379(9832):2162–72.

    Article  PubMed  Google Scholar 

  2. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371(9606):75–84.

    PubMed  PubMed Central  Google Scholar 

  3. Blencowe H, Lee AC, Cousens S, Bahalim A, Narwal R, Zhong N, et al. Preterm birth-associated neurodevelopmental impairment estimates at regional and global levels for 2010. Pediatr Res. 2013;74(Suppl 1):17–34.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Mwaniki MK, Atieno M, Lawn JE, Newton CR. Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review. Lancet. 2012;379(9814):445–52.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Romero R, Espinoza J, Kusanovic JP, Gotsch F, Hassan S, Erez O, et al. The preterm parturition syndrome. BJOG. 2006;113(Suppl 3):17–42.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014;345(6198):760–5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Boots AB, Sanchez-Ramos L, Bowers DM, Kaunitz AM, Zamora J, Schlattmann P. The short-term prediction of preterm birth: a systematic review and diagnostic metaanalysis. Am J Obstet Gynecol. 2014;210(1):54 e1–e10.

    Article  Google Scholar 

  8. Conde-Agudelo A, Papageorghiou AT, Kennedy SH, Villar J. Novel biomarkers for the prediction of the spontaneous preterm birth phenotype: a systematic review and meta-analysis. BJOG. 2011;118(9):1042–54.

    Article  CAS  PubMed  Google Scholar 

  9. Goulet C, Gevry H, Gauthier RJ, Lepage L, Fraser W, Aita M. A controlled clinical trial of home care management versus hospital care management for preterm labour. Int J Nurs Stud. 2001;38(3):259–69.

    Article  CAS  PubMed  Google Scholar 

  10. Salzmann M, Gaucherand P, Doret M. Prolonged hospitalization versus home management for women with arrested preterm labour: a before-after study. Gynecol Obstet Fertil. 2013;41(4):222–7.

    Article  CAS  PubMed  Google Scholar 

  11. Kunzier NB, Kinzler WL, Chavez MR, Adams TM, Brand DA, Vintzileos AM. The use of cervical sonography to differentiate true from false labor in term patients presenting for labor check. Am J Obstet Gynecol. 2016;215(3):372 e1–5.

    Article  Google Scholar 

  12. 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(5):1168–76.

    Article  CAS  PubMed  Google Scholar 

  13. 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(4):480 e1–e10.

    Article  Google Scholar 

  14. 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(6):399–402.

    PubMed  Google Scholar 

  15. 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(1):47–50.

    Article  CAS  PubMed  Google Scholar 

  16. Corabian P. The Actim Partus versus the TLiIQ system as rapid response tests to aid in diagnosing pretermlabor in symptomaticwomen [IHE rapid assessment level 2]. Edmonton (Canada): Institute of Health Economics 2008 Available at: http://www.iheca/download/actim_partus_vs_tliiq_system_preterm_labourpdf. Accessed April 10, 2015.

  17. Westwood M, Gibson JM, Davies AJ, Young RJ, White A. The phosphorylation pattern of insulin-like growth factor-binding protein-1 in normal plasma is different from that in amniotic fluid and changes during pregnancy. J Clin Endocrinol Metab. 1994;79(6):1735–41.

    CAS  PubMed  Google Scholar 

  18. 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(1):57–73.

    Article  CAS  PubMed  Google Scholar 

  19. Kekki M, Kurki T, Karkkainen 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(6):546–51.

    CAS  PubMed  Google Scholar 

  20. Eroglu D, Yanik F, Oktem M, Zeyneloglu HB, Kuscu E. Prediction of preterm delivery among women with threatened preterm labor. Gynecol Obstet Investig. 2007;64(2):109–16.

    Article  Google Scholar 

  21. Yoshida S, Martines J, Lawn JE, Wall S, Souza JP, Rudan I, et al. Setting research priorities to improve global newborn health and prevent stillbirths by 2025. J Glob Health. 2016;6(1):010508.

    PubMed  Google Scholar 

  22. Crowther CA. Hospitalisation and bed rest for multiple pregnancy. Cochrane Database Syst Rev. 2001;1:CD000110.

    Google Scholar 

  23. Vogel JP, Nardin JM, Dowswell T, West HM, Oladapo OT. Combination of tocolytic agents for inhibiting preterm labour. Cochrane Database Syst Rev. 2014;7:CD006169.

    Google Scholar 

  24. de Carvalho MH, Bittar RE, Brizot Mde L, Bicudo C, Zugaib M. Prediction of preterm delivery in the second trimester. Obstet Gynecol. 2005;105(3):532–6.

    Article  PubMed  Google Scholar 

  25. Fuchs IB, Henrich W, Osthues K, Dudenhausen JW. Sonographic cervical length in singleton pregnancies with intact membranes presenting with threatened preterm labor. Ultrasound Obstet Gynecol. 2004;24(5):554–7.

    Article  CAS  PubMed  Google Scholar 

  26. Goldenberg RL, Mercer BM, Iams JD, Moawad AH, Meis PJ, Das A, et al. The preterm prediction study: patterns of cervicovaginal fetal fibronectin as predictors of spontaneous preterm delivery. National Institute of Child Health and Human Development maternal-fetal medicine units network. Am J Obstet Gynecol. 1997;177(1):8–12.

    Article  CAS  PubMed  Google Scholar 

  27. Kurkinen-Raty M, Ruokonen A, Vuopala S, Koskela M, Rutanen EM, Karkkainen T, et al. Combination of cervical interleukin-6 and -8, phosphorylated insulin-like growth factor-binding protein-1 and transvaginal cervical ultrasonography in assessment of the risk of preterm birth. BJOG. 2001;108(8):875–81.

    CAS  PubMed  Google Scholar 

  28. Lembet A, Eroglu D, Ergin T, Kuscu E, Zeyneloglu H, Batioglu S, et al. 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(8):706–12.

    Article  PubMed  Google Scholar 

  29. 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.

    Article  PubMed  Google Scholar 

  30. Macones GA. Fetal fibronectin testing in threatened preterm labor: time to stop. Am J Obstet Gynecol. 2016;215(4):405.

    Article  PubMed  Google Scholar 

  31. Berghella V, Saccone G. Fetal fibronectin testing for prevention of preterm birth in singleton pregnancies with threatened preterm labor: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2016;215(4):431–8.

    Article  CAS  PubMed  Google Scholar 

  32. Khan KS, Khan SF, Nwosu CR, Arnott N, Chien PF. Misleading authors' inferences in obstetric diagnostic test literature. Am J Obstet Gynecol. 1999;181(1):112–5.

    Article  CAS  PubMed  Google Scholar 

  33. 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(3):631–40.

    Article  PubMed  Google Scholar 

  34. CNGOF. Prévention de la prématurité spontanée et de ses conséquences (hors rupture des membranes). Recommandations pour la pratique clinique. 2016.

  35. American, College, of, Obstetricians, and, Gynecologists’, et al. Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016;128:155–64.

    Article  Google Scholar 

  36. Melchor JC, Khalil A, Wing D, Schleussner E, Surbek D. Prediction of preterm delivery in symptomatic women using PAMG-1, fetal fibronectin and phIGFBP-1 tests: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018;52(4):442–51.

    Article  CAS  PubMed  Google Scholar 

  37. Nikolova T, Uotila J, Nikolova N, Bolotskikh VM, Borisova VY, di Renzo GC. Prediction of spontaneous preterm delivery in women presenting with premature labor: a comparison of placenta alpha microglobulin-1, phosphorylated insulin-like growth factor binding protein-1, and cervical length. Am J Obstet Gynecol. 2018;219:610.e1–9.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Hôpital Saint Joseph, 26 Boulevard de Louvain, FR-13008, Marseille, France

    Laura Tenoudji-Cohen Couka, Xavier-Côme Donato, Eric Glowaczower, Anne Squercioni-Aumont, Maria Katsogiannou & Raoul Desbriere

Authors
  1. Laura Tenoudji-Cohen Couka
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  2. Xavier-Côme Donato
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  3. Eric Glowaczower
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  4. Anne Squercioni-Aumont
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  5. Maria Katsogiannou
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  6. Raoul Desbriere
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Contributions

Protocol/project development: L Tenoudji-Cohen Couka, R Desbriere.

Data collection and management: L Tenoudji-Cohen Couka, XC Donato.

Data analysis: L Tenoudji-Cohen Couka, XC Donato, M Katsogiannou, R Desbriere.

Manuscript writing/editing: L Tenoudji-Cohen Couka, M Katsogiannou, R Desbriere.

Study and manuscript critical revision: E Glowaczower, A Squercioni-Aumont.

Corresponding author

Correspondence to Raoul Desbriere.

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Ethical Approval

This study was approved by the institution’s Ethics Committee (25/10/2018).

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The authors declare no conflict of interest.

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Informed consent was obtained from all individual participants included in the study.

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Consent was obtained from all participants.

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Tenoudji-Cohen Couka, L., Donato, XC., Glowaczower, E. et al. Does Assessment of Cervical Phosphorylated Insulin-like Growth Factor Binding Protein-1 by Bedside Vaginal Swab Test Really Predict Preterm Birth?. Reprod. Sci. 28, 2006–2011 (2021). https://doi.org/10.1007/s43032-020-00432-y

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  • DOI: https://doi.org/10.1007/s43032-020-00432-y

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