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European Fibronectin Study


Go to the EuFiS website.


Fetal fibronectin is an accurate predictor for the occurrence of preterm birth among women with threatened preterm labour. At present, the risk assessment for imminent preterm delivery consists either of observation of the frequency of  contractions, vaginal examinations, cervical length measurements, and/or qualitative fibronectin testing. Women who are thought to be at high risk are treated with tocolytics and corticosteroids. The use of a quantitative fibronectin test might be a cost-effective strategy to reduce unnecessary treatment.

This study will assess the capacity of quantitative fetal fibronectin testing as compared to or in addition of cervical length measurements and vaginal digital exams to predict preterm delivery in women with symptoms of preterm labour.


Study design
European multicenter cohort study.


Study population
A cohort of 500 pregnant women between 24 and 34 weeks of gestational age with preterm contractions and intact membranes.


Test under study
Quantitative fibronectin test.


Outcome measures
The primary outcome measure will be delivery within 7 days.
Secondary outcome measures will be gestational age at delivery, birth weight, neonatal morbidity, neonatal mortality and costs.


Power/data analysis
This study is powered to determine sensitivities of the quantitative fibronectin test.
We calculated by using the Wilson test that a sample size of 100 produces a two-sided 90% confidence interval with a width equal to 0,10 when the sample proportion is 0,90.
Given the anticipated 20% urgent cases of preterm delivery, at least 500 patients are needed in this study. Sample size heuristics for multivariable modelling indicate that including 500 patients allows the inclusion of at least 10 variables.


Time schedule
2012 – 2014


Prof. dr. B.W. Mol, gynaecoloog, epidemioloog.
Academic Medical Center, Amsterdam.




Drs. Esmé Kamphuis, arts-onderzoeker.
Academic Medical Center, Amsterdam
Drs. Gert-Jan van Baaren, arts-onderzoeker.
Academic Medical Center, Amsterdam