Fetal fibronectin testing in women with threatened preterm labour:

A best practice toolkit

Background and rationale
Aim
Fetal Fibronectin concentrations greater than
To optimise understanding and uptake or equal to 50ng/ml between 22 and 35 weeks
of Fibronectin testing in women with gestation are associated with an increased risk
threatened preterm labour in London. of preterm delivery. Using a 50ng/ml cut-off, the
fFN test has a negative predictive value (NPV) of
This toolkit has been produced as part of the 99.2 per cent and a positive predictive value (PPV)
London Maternity SCN’s strategy to identify areas of greater than 40 per cent for delivery within 14 days
good practice in the network, and then to implement in symptomatic women.
across all units to ensure equally good outcomes for
women who are pregnant and their babies. The risk of preterm GHOLYHU\can be further stratified
as fFN levels of less than 10ng/ml are associated with
The remit for the toolkit is to present the principles aneven lower risk, whilst the highest risk of preterm
underlying the use of fetal Fibronectin (fFN) testing delivery is seen with fFN levels of greater than
rather than an exhaustive guideline; it is envisaged 200ng/ml. The accuracy in predicting spontaneous
that all units will develop guidelines in line with these preterm birth within 7-10 days of testing among
principles. women with symptoms of threatened preterm
labour, before advanced cervical dilatation, has
Current management of threatened been confirmed in large studies1-3.
preterm labour
Birth before 34 completed weeks of pregnancy is a The most useful aspect of these test characteristics
significant cause of perinatal mortality and morbidity is that a negative fFN test makes it highly unlikely
in the UK. that a woman’s symptoms of preterm labour will
result in delivery within the next 14 days (less than 1
Current interventions that would be considered per cent).
in a mother at high risk of imminent delivery of a
premature baby include admission to hospital for If clinicians respond to this information appropriately
monitoring, administration of steroids or tocolytic and do not admit or treat women who have
drugs to the mother and possible transfer to a contractions, without ruptured membranes or a
specialist unit with appropriate staffing and expertise history of preterm birth, and who have a negative
to most successfully care for a baby born at the fFN test, then a number of potential benefits may be
extremes of viability. In particular, steroids and realised:
in utero transfer to a specialist unit have been
associated with improved neonatal outcomes. Efficiencies resulting from
»» Reduction in hospital admissions – Recent
However, the management of women who present Health Technology Assessment (HTA) review
with threatened preterm labour, defined as uterine suggests fFN testing is associated with cost
contractions but without cervical dilatation, is savings when admissions are avoided4.
complicated by the fact that more than 50 per cent »» Reduction of in utero transfer rate
will eventually deliver at term. Intervening in this (ambulance journeys)5.
group, who are not destined to deliver preterm, »» Reduction in planning and administrative
will therefore result in unnecessary exposure of time for arranging transfer.
the fetus to steroids unnecessary admission »» Drug treatment – reduction in the use of
to hospital and possibly transfer to another tocolytics (eg Atosiban) and steroids.
unit. Improved maternal experience by
»» Avoiding unnecessary hospital admission.
Role of fetal Fibronectin testing »» Avoiding ambulance transfer to an
Fetal Fibronectin (fFN) is a glycoprotein which can unfamiliar unit.
be detected in a woman’s cervicovaginal secretions »» Providing reassurance that preterm
throughout pregnancy, with low levels between 22 delivery is not imminent.
and 35 weeks of gestation.

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January2014
Improved service by above, will not be realised unless clinicians perform
»» Reducing the number of beds blocked and interpret the test correctly. For instance, a
by unnecessary admission and transfer. recent HTA analysis found that cost savings were
Currently, 47 per cent referrals to the only achieved if clinicians did not admit women with
Emergency Bed Service in London for in utero a negative fFN test.
transfer are unsuccessful because there is no
room; the median administrative time spent on It is essential, therefore, that test implementation is
these failed transfers is 340 minutes, involving more extensive than purchasing the swabs and point
discussions with between six and eight units6. of care testing equipment.

All units will require a protocol that includes ongoing

Principles for the use of fFN testing in education about use and interpretation of findings.
the London Maternity SCN
»» Fibronectin is used in the management of Audit
women with threatened preterm labour and Auditable standards include:
intact membranes. »» The proportion of women presenting with
»» All network providers will have access to threatened preterm labour tested for fFN.
automated fetal Fibronectin analysis. »» The proportion of women with threatened
»» Network providers will have local guidelines for preterm labour and a negative fFN who
the use of Fibronectin testing. received steroids, tocolysis, were admitted to
»» A Fibronectin swab will be used to sample hospital and/or were transferred to another
cervicovaginal fluid in the posterior fornix in unit.
all women with symptoms of preterm labour »» The proportion of women with threatened
between 22 and 35 weeks gestation, with preterm labour and a positive fFN who
intact membranes and cervical dilatation less received steroids, tocolysis, were admitted to
than 3 cm. hospital and/or were transferred to another
»» The swab should be taken prior to digital unit.
examination.
»» If the test is negative, the risk of preterm
delivery within 10 days is 1 per cent. Steroids, Further reading
tocolysis and in utero transfer are therefore not 1. Leitich H, Egarter C, Kaider A et al. Cervicovaginal
indicated. fetal fibronectin as a marker for preterm delivery: A
meta-analysis. American Journal of Obstetrics and
»» If the test is positive, the risk of preterm
Gynaecology. 1999;180:1169-1176
labour is increased and steroids, tocolysis 2. Tsoi E, Akmal S, Geerts L, Jeffery B, Nicolaides
and in utero transfer (if necessary) should be KH. Sonographic measurement of cervical length
considered. and fetal fibronectin testing in threatened preterm
»» Ruptured membranes, recent sexual labour. Ultrasound in Obstetrics and Gynaecology.
intercourse, placenta praevia, abruption, 2006; 27:368-372
heavy vaginal bleeding, cervical suture or 3. Abbott DS, Radford SK, Seed PT, Tribe RM,
recent cervical manipulation increase the risk Shennan AH. (2013) Evaluation of a quantitative
of a false positive test. fetal fibronectin test for spontaneous preterm
»» If the test is reported as invalid on birth in symptomatic women. American Journal of
Obstetrics and Gynaecology. 208:122.e1-6.
two occasions, Fibronectin testing is
4. Deshpande SN, van Asselt ADI, Tomini F,
contraindicated (eg digital exam performed) or Armstrong N, Allen A, Noake C, Khan K, Severens
Fibronectin is negative but the woman is still JL, Kleijnen I, Westwood ME. Rapid fetal
contracting, then trans-vaginal ultrasound can fibronectin testing to predict preterm birth in women
be used to measure cervical length. The risk with symptoms of premature labour: A systematic
of preterm labour is very low if the cervix is review and cost analysis. National Institute for
greater than 15 mm. Health Research Health Technology Assessment
»» In utero transfer because of perceived risk Volume 17, Issue 40: September 2013
of preterm labour (in women with intact 5. Fenton A, Peebles D, Ahluwalia J. Management of
membranes) should not occur from network acute in utero transfers: A framework for practice.
British Association of Perinatal Medicine. 25 June
providers without prior Fibronectin analysis.
2008 C.
6. Gale C, Hay A, Philipp C, Khan R, Santhakumaran
Education S, Ratnavel N. (2012) In utero transfer is too
The benefits associated with fFN testing, outlined difficult: Results from a prospective study. Early
Human Development; 88:147-150.
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Author: Professor Donald Peebles. For more information, please contact Professor Donald Peebles via the
London Maternity Strategic Clinical Network, [email protected].