Objective Data
Fetal fibronectin is an extracellular matrix glycoprotein that is produced by amniocytes
and cytotrophoblasts and has been shown to predict spontaneous preterm birth.
Study
The aim of this systematic review and metaanalysis of randomized clinical trials was
to evaluate the effect of the use of fetal fibronectin in the prevention of preterm
birth in singleton pregnancies with threatened preterm labor.
Study Appraisal and Synthesis Methods
The research was conducted with the use of MEDLINE, EMBASE, Web of Sciences, Scopus,
ClinicalTrial.gov, OVID, and Cochrane Library as electronic databases from the inception of each database
to February 2016. Selection criteria included randomized clinical trials of singleton
gestations with threatened preterm labor that were assigned randomly to management
based on fetal fibronectin results (ie, intervention group) or not (ie, comparison
group). Types of participants included women with singleton gestations at 23 0/7 to
34 6/7 weeks with threatened preterm labor. Studies that included management that
was also based on the use of sonographic cervical length were excluded. The primary
outcome was preterm birth at <37 weeks of gestation. The summary measures were reported
as relative risk or as mean differences with 95% confidence interval.
Results
Six trials that included 546 singleton gestations with symptoms of preterm labor were
included in the metaanalysis. The overall risk of bias of the included trials was
low. Women were eligible for the random assignment in case of symptoms that suggested
preterm labor at 23–34 weeks of gestation. During admission, before digital examination,
a Dacron swab was rotated in the posterior fornix for 10 seconds to absorb cervicovaginal
secretions that were then analyzed for the fetal fibronectin qualitative method, with
results reported as either positive or negative. Women who were assigned randomly
to the fetal fibronectin group had a similar incidence of preterm birth at <37 weeks
of gestation (20.7% vs 29.2%; relative risk, 0.72; 95% confidence interval, 0.52–1.01),
at <34 weeks of gestation (8.3% vs 7.9%; relative risk, 1.09; 95% confidence interval,
0.54–2.18), at <32 weeks of gestation (3.3% vs 5.6%; relative risk, 0.64; 95% confidence
interval, 0.24–1.74), and at <28 weeks of gestation (1.1% vs 1.7%; relative risk,
0.74; 95% confidence interval, 0.15–3.67) compared with the control group. No differences
were found in the number of women who delivered within 7 days (12.8% vs 14.5%; relative
risk, 0.76; 95% confidence interval, 0.47–1.21), in the mean of gestational age at
delivery (mean difference, 0.20 week; 95% confidence interval, –0.26 to 0.67), in
the rate of maternal hospitalization (27.4% vs 26.9%; relative risk, 1.07; 95% confidence
interval, 0.80–1.44), in the use of tocolysis (25.3% vs 28.2%; relative risk, 0.97;
95% confidence interval, 0.75–1.24), antenatal steroids (29.2% vs 29.2%; relative
risk, 1.05; 95% confidence interval, 0.79–1.39), in the mean time in the triage unit
(mean difference, 0.60 hour; 95% confidence interval, –0.03 to 1.23) and in neonatal
outcomes that included respiratory distress syndrome (1.3% vs 1.5%; relative risk,
0.91; 95% confidence interval, 0.06–14.06), and admission to the neonatal intensive
care unit (19.4% vs 8.1%; relative risk, 2.48; 95% confidence interval, 0.96–6.46).
Management based on the fetal fibronectin test required higher hospitalization charges
(mean difference, $153; 95% confidence interval, 24.01–281.99).
Conclusion
Fetal fibronectin testing in singleton gestations with threatened preterm labor is
not associated with the prevention of preterm birth or improvement in perinatal outcome
but is associated with higher costs.
Key words
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Article info
Publication history
Published online: April 28, 2016
Accepted:
April 20,
2016
Received in revised form:
April 19,
2016
Received:
March 4,
2016
Footnotes
The authors report no conflict of interest.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Randomized clinical trials are not always the best way to assess diagnostic tests: the case of fetal fibronectin testingAmerican Journal of Obstetrics & GynecologyVol. 218Issue 1
- PreviewRecently, Berghella and Saccone1 published in this journal a meta-analysis on fetal fibronectin as predictor of preterm birth. In this meta-analysis, the authors concluded that women assigned randomly to the knowledge of fibronectin results did not have reduced preterm birth rates compared to a control group. In addition, both groups had similar rates of hospitalization, and use of tocolytics and steroids. Mean hospital costs were even slightly higher in the fetal fibronectin group. This conclusion was based on 6 randomized clinical trials (RCTs) reporting on 546 women with threatened preterm labor; 13% of the included delivered within 1 week after presentation.
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