OBSTETRICS
OBSTETRICS
Contingent Use of Fetal Fibronectin Testing and
Cervical Length Measurement in Women With
Preterm Labour
François Audibert, MD, MSc, Suzanne Fortin, MD, Edgard Delvin, PhD, Anissa Djemli, PhD,
Suzanne Brunet, RT, Johanne Dubé, MD, FRCOG, William D. Fraser, MD, MSc
Département d’Obstétrique Gynécologie, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montréal (Quebec)
Abstract
Objective: To evaluate the contingent use of fetal fibronectin (fFN)
testing and cervical length (CL) measurement to predict preterm
delivery, and to validate the use of phosphorylated IGFBP-1 as a
predictor of preterm delivery.
Methods: We recruited 71 women with a clinical diagnosis of
preterm labour between 24 and 34 weeks, and tested for the
presence of fFN and IGFBP-1 in the cervicovaginal secretions of
all women immediately before CL measurement.
Results: Among the 66 women with complete outcome, four were
excluded from the final analysis as two had assessment for fFN
but no CL measurement, and another two had CL measured but
no screening for fFN. Among 62 women with complete results, the
mean gestational age at recruitment was 29.4 ± 2.5 weeks. Six
women (9.6%) delivered within two weeks of assessment, and 14
(22.5%) delivered before 34 weeks. A positive fFN test resulted in
a sensitivity of 83%, a specificity of 84%, a positive predictive
value of 36%, and a negative predictive value of 98% for delivery
within two weeks; for CL < 25 mm, these figures were 50%, 52%,
10%, and 91%, respectively, and for a positive IGFBP-1, they were
17%, 93%, 20%, and 91%, respectively. A policy of contingent use
of fFN (in which the test was assumed to be positive if CL £ 15 mm,
and fFN was only measured if the CL was between 16 and 30 mm)
gave sensitivity, specificity, positive and negative predictive values
of 80%, 61%, 17%, and 97%, respectively for delivery within two
weeks. Using this contingent use protocol, only one third of
women needed fFN screening after CL measurement.
Conclusion: In this study, IGFBP-1 screening did not predict preterm
delivery and fFN screening provided the best predictive capacity.
A policy of contingent use of testing for fFN after CL measurement,
or contingent use of CL measurement after fFN screening
(depending on available resources) is a promising approach to
limit use of resources.
Key Words: Preterm labour, cervical length, fetal fibronectin,
IGFBP-1
Competing Interests: None declared.
Received on June 11, 2009
Accepted on August 27, 2009
Résumé
Objectif : Évaluer l’utilisation contingente du dépistage de la
fibronectine fœtale (FNf) et de la mesure de la longueur cervicale
(LC) pour prédire l’accouchement préterme, ainsi que valider
l’utilisation de l’IGFBP-1 phosphorylée à titre de facteur prédictif
de l’accouchement préterme.
Méthodes : Nous avons recruté 71 femmes ayant obtenu un
diagnostic clinique de travail préterme entre 24 et 34 semaines,
et nous avons cherché à déterminer la présence de FNf et
d’IGFBP-1 dans les sécrétions cervicovaginales de toutes les
femmes, immédiatement avant la mesure de la LC.
Résultats : Parmi les 66 femmes ayant connu une issue complète,
quatre ont été exclues de l’analyse finale puisque deux d’entre
elles avaient subi un dépistage de la FNf sans qu’une mesure de
la LC ne soit effectuée, tandis que la LC des deux autres avait été
mesurée sans qu’un dépistage de la FNf ne soit mené. Chez les
62 femmes présentant des résultats complets, l’âge gestationnel
moyen au moment de l’admission à l’étude était de 29,4 ±
2,5 semaines. Six femmes (9,6 %) ont accouché dans les deux
semaines suivant l’évaluation et 14 (22,5 %) ont accouché avant
e
la 34 semaine de gestation. Un résultat positif au test FNf donnait
lieu à une sensibilité de 83 %, une spécificité de 84 %, un
coefficient de prévision d’un test positif de 36 % et un coefficient
de prévision d’un test négatif de 98 % pour ce qui est d’un
accouchement dans les deux semaines; en ce qui concerne une
LC <25 mm, ces valeurs étaient de 50 %, de 52 %, de 10 % et de
91 %, respectivement, tandis que dans le cas d’un résultat positif
au test IGFBP-1, elles étaient de 17 %, de 93 %, de 20 % et de
91 %, respectivement. Une politique d’utilisation contingente du
dépistage de la FNf (selon laquelle le test était présumé positif
lorsque la LC £ 15 mm et la FNf n’était mesurée que lorsque la LC
se situait entre 16 et 30 mm) a donné lieu à une sensibilité, une
spécificité, un coefficient de prévision d’un test positif et un
coefficient de prévision d’un test négatif de 80 %, de 61 %, de
17 % et de 97 %, respectivement, pour ce qui est d’un
accouchement dans les deux semaines. En utilisant ce protocole
d’utilisation contingente, seul le tiers des femmes nécessitait un
dépistage de la FNf à la suite de la mesure de la LC.
Conclusion : Dans le cadre de cette étude, le dépistage de
l’IGFBP-1 n’a pas permis de prédire l’accouchement préterme; le
dépistage de la FNf a présenté la meilleure capacité de prévision.
L’adoption d’une politique d’utilisation contingente du dépistage de
la FNf à la suite de la mesure de la LC ou d’utilisation contingente
de la mesure de la LC à la suite du dépistage de la FNf (selon les
ressources disponibles) constitue une approche prometteuse pour
ce qui est de limiter l’utilisation des ressources.
J Obstet Gynaecol Can 2010;32(4):307–312
APRIL JOGC AVRIL 2010 l 307
OBSTETRICS
INTRODUCTION
P reterm birth remains a major cause of perinatal morbid-
ity and mortality,1 and its rate has not declined over the
last two decades despite the improvement in perinatal man-
agement.2 Assessing the probability of preterm delivery is
still a clinical challenge and is important because standard
clinical interventions (tocolysis, corticosteroid administra-
tion, and transfer to a tertiary care facility) are potentially
risky and expensive. Previous studies have shown that a
diagnosis of preterm labour based on digital examination
was less reliable than a diagnosis based on objective tests,
such as detection of fetal fibronectin in cervicovaginal
secretions and ultrasound measurement of cervical length.3
Fetal fibronectin, an extracellular matrix glycoprotein local-
ized at the maternal–fetal interface of the amniotic mem-
branes between the chorion and the decidua, is found at
very low levels in cervicovaginal secretions under normal
conditions. Levels ³ 50 ng/mL at or after 22 weeks’ gesta-
tion have been associated with an increased risk of sponta-
neous preterm birth.3–6 A recent meta-analysis has shown
that birth before 37 weeks was significantly decreased in
patients whose management was based on knowledge of
fFN results compared with controls whose fFN results
were not known.7
Transvaginal CL measurement is the other validated test to
predict preterm birth in women with threatened preterm
labour as well as in asymptomatic high-risk and low-risk
women.3,8–14 A CL measurement of 25 mm or less is gener-
ally considered an excellent indicator of an increased risk of
preterm delivery, particularly among women with preterm
labour.
Several studies have reported that fFN screening and CL
measurement provided similar results in predicting the risk
of preterm delivery.15–20 However, whether combined fFN
and CL measurement improves the prediction of preterm
delivery and how the tests should be combined remain
unclear.3 Availability of one of the two tests may be an issue
in some facilities because the ultrasound expertise for CL
measurement may not be always available in small centres.
On the other hand, the additional cost of fFN testing may
be difficult to justify in centres where CL measurement is
readily available. Therefore, the use of CL or fFN as the
first-line test might be a more rational option, limiting the
ABBREVIATIONS
CL cervical length
fFN fetal fibronectin
IGFBP-1 insulin-like growth factor binding protein-1
308 l APRIL JOGC AVRIL 2010
use of a second test to selected cases in a contingent
approach.
More recently, a rapid test for the determination of the insu-
lin-like growth factor binding protein phosphorylated
isoform in endocervical secretions has been proposed.21–24
Although IGFBP-1 is synthesized in the decidua and the
liver, decidual cells predominantly secrete the
phosphorylated form, which in normal conditions is not
present in amniotic fluid and cervical secretions.
The objective of the present study was to determine the per-
formance of a contingent use of fFN testing and ultrasound
CL measurement for the prediction of preterm delivery in
patients with preterm labour. A secondary objective was to
validate the use of cervical IGFBP-1 measurement for the
prediction of preterm delivery.
MATERIALS AND METHODS
Women admitted to our tertiary care unit with a clinical
diagnosis of preterm labour and intact membranes between
24 and 34 weeks were approached to participate in the study
and were included after providing informed consent.
Preterm labour was defined by the presence of regular uter-
ine contractions, lasting at least 30 seconds and occurring at
least four times per 30 minutes, and significant cervical
changes on digital examination. Women were excluded if
they had confirmed or suspected rupture of membranes,
cervical dilatation > 3 cm, cervical cerclage, vaginal bleed-
ing, placenta previa, placental abruption, severe intrauterine
growth restriction, preeclampsia, or medically indicated
preterm delivery before 34 weeks.
The study investigations were carried out either on admis-
sion or within 24 hours of admission if a digital examination
had been performed in the 24 hours before the patient’s
inclusion in the study. Each subject was first examined with
a vaginal speculum. A Dacron swab was rotated in the pos-
terior fornix of the vagina and sent to the laboratory. The
presence or absence of fFN was measured by a qualitative
test (Full Term, Hologic, Marlborough, MA), and results
were expressed as positive or negative. A second swab
(Actim Partus, Somagen, Edmonton AB) was taken in the
cervix and held for 15 seconds, then dipped into a sterile
medium and held for another 10 seconds. Following this, a
dipstick was used to determine if the test was positive (two
blue lines), suggesting a concentration of IGFBP-1 in the
cervical secretions higher than 10 mg/L, or negative (single
blue line after 5 minutes). Immediately after the sampling, a
transvaginal sonographic measurement of the cervical
length was performed by a trained sonographer, or by a resi-
dent under direct supervision of a faculty member, using a
standard protocol (empty bladder, minimal pressure,
measurement of the maximum length between the internal
 Contingent Use of Fetal Fibronectin Testing and Cervical Length Measurement in Women With Preterm Labour
Figure 1. Contingent use of fetal fibronectin testing
and external os, before and after Valsalva manoeuvre).25,26
The clinical team were not blinded to the results of fFN
testing and CL measurement, and these results were avail-
able in the medical record. The results of IGFBP-1 testing
were not disclosed to the clinician in charge and were not
reported in the medical record. The standard local manage-
ment protocol for preterm labour was applied to the study
patients: administration of corticosteroids, administration
of tocolytics for a maximum of 48 hours, and bed rest were
prescribed by the attending physician, depending on clinical
evaluation and on the results of investigations, including
fFN and CL measurement. The reproducibility of CL mea-
surement or fFN assessment was not tested in this study.
The outcome of the pregnancy was recorded in a database
with other information pertinent to the project. The out-
comes of interest were delivery within two weeks of admis-
sion to the study and delivery before 34 weeks.
Predictive values and likelihood ratios with their 95% confi-
dence interval were first calculated for each test considered
separately, then for different combinations of both markers
used in a contingent manner. The “contingent use of fFN”
test was considered positive if cervical length was £ 15 mm
or between 16 and 30 mm with positive fFN, as described
by Schmitz et al.20 The test was considered negative if cervical
length was > 30 mm or between 16 and 30 mm with negative
fFN (Figure 1). The “contingent use of CL” test was con-
sidered positive if fFN was positive, or if fFN was negative
with a CL £ 15 mm. The test was considered negative if fFN
was negative and CL > 15 mm (Figure 2). Predictive values
were compared using the McNemar chi-square test. All
analyses were performed with Stata 10.0 software
(StataCorp LP, College Station, TX).
The Ethics Committee of Centre Hospitalier Universitaire
Sainte-Justine approved this prospective study.
Figure 2. Contingent use of cervical length measurement
RESULTS
Seventy-one women were recruited for the study between
January 2006 and January 2007. The outcome of pregnancy
could not be determined for five women who had been dis-
charged and delivered in another centre. Among the 66
remaining women, two had a fFN assessment but no CL
measurement, and another two had CL measured but no
evaluation of fFN. These cases were excluded from further
analysis. Sixty-two women were included in the final analy-
sis, including seven twin pregnancies, and 37 (60%) women
were initially transferred from another centre because of
preterm labour. Six women (9.6%) delivered within two
weeks, and 14 women (22.5%) delivered before 34 weeks.
General characteristics and pregnancy outcome in study
subjects are summarized in Table 1.
The values of the different tests in predicting delivery within
two weeks and before 34 weeks are shown in Table 2. The
best single test for the prediction of delivery within two
weeks was fFN (sensitivity 83% and specificity 84%),
whereas CL measurement had a slightly better sensitivity
than fFN (71 vs. 50%, respectively) for predicting delivery
before 34 weeks. The specificity of fFN was significantly
better than CL measurement (P < 0.001) and similar to the
specificity of contingent testing. With a policy of contingent
use of fFN (fFN tested only for CL more than 15 mm but
less than 30 mm), the fFN testing could have been avoided
in 40 of 62 women (65%). With a policy of contingent mea-
surement of CL (CL measured only if negative fFN), the CL
measurement could have been avoided in 14 of 62 women
(23%). Overall, we found no significant difference between
the sensitivity of fFN testing, CL measurement, and their
combinations.
The predictive values of the IGFBP-1 test were very poor,
with a sensitivity of 17% and 14% for the prediction of
preterm delivery within two weeks and before 34 weeks,
respectively.
APRIL JOGC AVRIL 2010 l 309
OBSTETRICS

testing. The swab is simply discarded if the test is deemed

Table 1. General characteristics, pregnancy outcome,
and test results
unnecessary on the basis of CL measurement

Characteristics N = 62
There is no consensus about the benefits of combining fFN
testing and CL measurement in women with preterm
Maternal age in years, mean ± SD 27.6 ± 6.2 labour. Rozenberg et al.,16 using a one-step combination
Nulliparous, n (%) 29 (46.8) (both tests performed for every patient), found the combi-
Maternal transfer, n (%) 37 (59.7) nation of tests to have limited value, whereas several other
Gestational age at inclusion in weeks, mean ± SD 29.4 ± 2.5 studies reported increased predictive values when both tests
Gestational age at delivery in weeks, mean ± SD 36.5 ± 3.2 were combined in various ways.15,18–20 The selective use of
Received tocolytics, n (%) 44 (71.0) fFN after CL measurement, similar to the contingent use we
Delivery within 2 weeks, n (%) 6 (9.7) tested, was proposed by Hincz et al.18 and by Schmitz et al.20
Delivery before 34 weeks, n (%) 14 (22.6) Both studies found an improved specificity when fFN test-
Delivery before 37 weeks, n (%) 23 (37.1) ing was limited to cases of intermediate measurement of CL
Admission to delivery interval in days, mean ± SD 49.9 ± 22.8 (21–31 mm for Hincz, and 16–30 mm for Schmitz). Gomez
Median cervical length in mm (range) 26.5 (0–51) et al.19 found a significant improvement in the prediction of
Cervical length < 15 mm 16 (28.8) preterm delivery when fFN was tested after a CL < 30 mm.
Cervical length < 25 mm 30 (48.4)
We were unable to find any report of the contingent use of
CL measurement after fFN testing.
Cervical length ³ 30 mm 24 (38.7)
Positive fFN, n (%) 14 (22.6) Our study has some limitations. First, the clinicians provid-
Positive IGFBP-1, n (%) 5 (8.1 ) ing care for the women, except for IGFBP-1, were not
blinded to the results of the tests, and the results of the tests
might have changed the management of the pregnancy.
However, the primary goal of this study was not to validate
DISCUSSION fFN and CL as markers of the risk of preterm delivery,
which has been done previously, but rather to test their con-
The results of this study confirm that both cervicovaginal tingent use. Another limitation of the study is its relatively
fFN testing and endovaginal CL measurement provide small sample size. We cannot exclude a lack of statistical
good prediction of delivery within two weeks or before power to detect subtle differences in the predictive values
34 weeks in women with threatened preterm labour. In between the various combinations of tests. However, we
addition, we have tested two different strategies combining believe that this study provides important information to
both tests, with the aim of improving the predictive value while obstetric care providers who have to choose a rational
decreasing the need for additional resources. For the pre- algorithm for management in cases of threatened preterm
diction of delivery within two weeks, the best performance labour, adapted to the local resources. The reproducibility
was provided by fFN testing alone, whereas contingent use of measurements was not tested in this study. However,
of CL measurement was the best predictor of delivery numerous reports have confirmed that both cervical length
before 34 weeks. However, the sensitivities did not differ measurement and fFN testing had a good to excellent
significantly between the various combinations; this means reproducibility.3 We chose not to perform a cost-effectiveness
that, depending on local resources, a choice can be made analysis,27 because the cost of cervical length measurement
among these options. In facilities where vaginal ultrasound is highly dependent on the availability of vaginal ultrasound
equipment and expertise are readily available (especially in and expertise. Depending on the type of facility and
tertiary care centres), CL measurement is a good test for the available staff, the choice of the first-line test, fFN testing, or
initial triage. When CL results are in an intermediate range, CL measurement, provides similar predictive values among
fFN testing clearly provides useful additional information women with threatened preterm labour.
to decide whether the woman with resolved preterm labour A secondary objective of this study was to validate the use
can be discharged. In facilities where vaginal ultrasound is of phosphorylated IGFBP-1 as a marker of an increased
not routinely offered, fFN testing offers an excellent option risk of preterm delivery. In contrast to previous
to decide if a woman with preterm labour requires treat- reports,21–24,28–30 our study found that IGFBP-1 was a very
ment and referral to a tertiary facility. Whatever the strategy poor predictor of preterm delivery. Only five women out of
used, it is important to perform the fFN swab sampling 62 tested had a positive result, and the sensitivity for the
before any other vaginal examination (CL measurement or detection of preterm delivery was extremely low, below
digital examination) as routinely recommended for fFN 20%. The reasons for this poor performance are unclear.

310 l APRIL JOGC AVRIL 2010

 Contingent Use of Fetal Fibronectin Testing and Cervical Length Measurement in Women With Preterm Labour

Table 2. Predictive values for preterm birth of cervical length, fFN, IGFBP-1, and contingent use of fFN and cervical
length

Sensitivity Specificity LR+ LR– PPV NPV

Delivery % (95% CI) % (95% CI) (95% CI) (95% CI) % (95% CI) % (95% CI)

Within 2 weeks
(prev 9.7%)
fFN + 83 (36–100) 84 (72–92) 5.2 (2.6–10.4) 0.2 (0.0–1.2) 36 (13–65) 98 (89–100)
IGFBP-1 17 (0–64) 93 (83–98) 2.3 (0.3–17.6) 0.9 (0.6–1.3) 20 (0.5–72) 91 (81–97)
CL < 25 mm 50 (12–88) 52 (38–65) 1.0 (0.4–2.4) 1.0 (0.4–2.2) 10 (2–26) 91 (75–98)
Contingent fFN 50 (12–88) 64 (50–77) 1.4 (0.6–3.3) 0.8 (0.3–1.8) 13 (3–34) 92 (79–98)
Contingent CL 83 (36–100) 62 (48–75) 2.2 (1.4–3.6) 0.3 (0.0–1.6) 19 (6–39) 97 (85–100)
< 34 weeks
(prev 22.6%)
fFN + 50 (23–77) 85 (72–94) 3.4 (1.4–8.1) 0.6 (0.3–1.0) 50 (23–77) 85 (72–94)
IGFBP-1 14 (2–43) 94 (83–99) 2.3 (0.4–12.4) 0.9 (0.7–1.1) 40 (5–85) 79 (66–89)
CL < 25 mm 71 (42–92) 58 (43–72) 1.7 (1.1–2.7) 0.5 (0.2–1.2) 33 (17–53) 87 (71–96)
Contingent fFN 64 (35–87) 71 (56–83) 2.2 (1.2–3.4) 0.5 (0.2–1.0) 39 (20–61) 87 (73–96)
Contingent CL 71 (42–92) 67 (52–80) 2.1 (1.3–3.6) 0.4 (0.2–1.0) 38 (20–59) 89 (74–97)
< 37 weeks
(prev 37.1%)
fFN + 48 (35–60) 92 (86–99) 6.2 (1.9–20.0) 0.5 (0.4–0.8) 79 (68–89) 75 (64–86)
IGFBP-1 13 (5–21) 95 (89–100) 2.5 (0.5–14) 0.9 (0.8–1.1) 60 (48–72) 65 (53–77)
CL < 25 mm 74 (52–90) 67 (50–81) 2.2 (1.3–3.7) 0.4 (0.2–0.8) 57 (37–74) 81 (64–93)
Contingent fFN 56 (34–77) 74 (58–87) 2.2 (1.2–4.2) 0.6 (0.4–1.0) 56 (34–77) 74 (58–87)
Contingent CL 65 (43–84) 72 (55–85) 2.3 (1.3–4.1) 0.5 (0.3–0.9) 58 (37–77) 78 (61–90)

fFN+: positive fetal fibronectin test; CL: cervical length; contingent fFN: CL measured in all cases, and fFN only for CL between 16 and 30 mm; contingent CL: fFN
tested in all cases, and CL only for negative fFN; LR+: likelihood ratio for a positive result; LR–:likelihood ratio for a negative result; PPV: positive predictive value;
NPV: negative predictive value; prev: prevalence;
P > 0.05 for all comparisons between sensitivities; P< 0.001 vs. CL.

We followed the manufacturer’s instructions carefully. The
sample size of the current study is similar to those of previ-
ous reports. As with all new techniques, there is a potential
publication bias, since positive results are more likely to be
published than studies with negative results.31 We therefore
believe that the use of IGFBP-1 as a marker of preterm
delivery with intact membranes requires further prospective
these tests on preterm birth rates, the duration of hospital-
ization, and overall costs now must be evaluated in
prospective studies.
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