The predictive value of quantitative fibronectin testing in combination with cervical length measurement in symptomatic women

Merel M.C. Bruijn, Esme I. Kamphuis, Irene M. Hoesli, Begoña Martinez de Tejada, Anne R. Loccufier, Maritta Kühnert, Hanns Helmer, Marie Franz, Martina M. Porath, Martijn A. Oudijk, Yves Jacquemyn, Sven M. Schulzke, Grit Vetter, Griet Hoste, Jolande Y. Vis, Marjolein Kok, Ben W.J. Mol, Gert Jan van Baaren

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Abstract

Background The combination of the qualitative fetal fibronectin test and cervical length measurement has a high negative predictive value for preterm birth within 7 days; however, positive prediction is poor. A new bedside quantitative fetal fibronectin test showed potential additional value over the conventional qualitative test, but there is limited evidence on the combination with cervical length measurement. Objective The purpose of this study was to compare quantitative fetal fibronectin and qualitative fetal fibronectin testing in the prediction of spontaneous preterm birth within 7 days in symptomatic women who undergo cervical length measurement. Study Design We performed a European multicenter cohort study in 10 perinatal centers in 5 countries. Women between 24 and 34 weeks of gestation with signs of active labor and intact membranes underwent quantitative fibronectin testing and cervical length measurement. We assessed the risk of preterm birth within 7 days in predefined strata based on fibronectin concentration and cervical length. Results Of 455 women who were included in the study, 48 women (11%) delivered within 7 days. A combination of cervical length and qualitative fibronectin resulted in the identification of 246 women who were at low risk: 164 women with a cervix between 15 and 30 mm and a negative fibronectin test (<50 ng/mL; preterm birth rate, 2%) and 82 women with a cervix at >30 mm (preterm birth rate, 2%). Use of quantitative fibronectin alone resulted in a predicted risk of preterm birth within 7 days that ranged from 2% in the group with the lowest fibronectin level (<10 ng/mL) to 38% in the group with the highest fibronectin level (>500 ng/mL), with similar accuracy as that of the combination of cervical length and qualitative fibronectin. Combining cervical length and quantitative fibronectin resulted in the identification of an additional 19 women at low risk (preterm birth rate, 5%), using a threshold of 10 ng/mL in women with a cervix at <15 mm, and 6 women at high risk (preterm birth rate, 33%) using a threshold of >500 ng/mL in women with a cervix at >30 mm. Conclusion In women with threatened preterm birth, quantitative fibronectin testing alone performs equal to the combination of cervical length and qualitative fibronectin. Possibly, the combination of quantitative fibronectin testing and cervical length increases this predictive capacity. Cost-effectiveness analysis and the availability of these tests in a local setting should determine the final choice.

Original languageEnglish
Pages (from-to)793.e1-793.e8
Number of pages8
JournalAmerican Journal of Obstetrics and Gynecology
Volume215
Issue number6
DOIs
Publication statusPublished - 1 Dec 2016
Externally publishedYes

Keywords

  • cervical length
  • fetal fibronectin
  • prediction
  • predictive value
  • preterm birth
  • threatened preterm labor

Cite this

Bruijn, M. M. C., Kamphuis, E. I., Hoesli, I. M., Martinez de Tejada, B., Loccufier, A. R., Kühnert, M., Helmer, H., Franz, M., Porath, M. M., Oudijk, M. A., Jacquemyn, Y., Schulzke, S. M., Vetter, G., Hoste, G., Vis, J. Y., Kok, M., Mol, B. W. J., & van Baaren, G. J. (2016). The predictive value of quantitative fibronectin testing in combination with cervical length measurement in symptomatic women. American Journal of Obstetrics and Gynecology, 215(6), 793.e1-793.e8. https://doi.org/10.1016/j.ajog.2016.08.012