Abstract
OBJECTIVE: Our aim was to determine whether the presence of fetal fibronectin in vaginal secretions
of patients with symptoms suggestive of preterm labor predicts preterm delivery. STUDY DESIGN: Patients who were examined at the hospital between 24 weeks' and 34 weeks 6 days'
gestation with intact membranes, no prior tocolysis, symptoms suggestive of preterm
labor, and cervical dilation <3 cm were recruited at 10 sites. Swabs of the posterior
fornix were assayed for the presence of fetal fibronectin by monoclonal antibody assay,
with a positive result defined as ≥50 ng/ml. Results were not available to the managing
physicians. Tocolysis was used when clinically indicated after specimen collection.
RESULTS: A total of 763 patients had fetal fibronectin results and pregnancy outcome data
available for analysis. Fetal fibronectin was detected in specimens from 150 (20%)
patients. Compared with patients who had negative results, patients who had positive
results for fetal fibronectin were more likely to be delivered within 7 days (relative
risk 25.9 [95% confidence interval 7.8 to 86]), within 14 days (relative risk 20.4
[95% confidence interval 8.0 to 53]), and before 37 completed weeks (relative risk
2.9 [95% confidence interval 2.2 to 3.7]). The negative predictive values for delivery
within 7 days, within 14 days, and at <37 weeks were 99.5%, 99.2%, and 84.5%, respectively.
When we used multiple logistic regression analysis to control for potential confounding
variables among singleton pregnancies, only the presence of fetal fibronectin (odds
ratio 48.8, 95% confidence interval 7.4 to 320), prior preterm birth (odds ratio 8.3,
95% confidence interval 1.5 to 46.6), and tocolysis (odds ratio 4.1, 95% confidence
interval 1.0 to 16.0) were associated with birth within 7 days; fetal fibronectin
(odds ratio 3.6, 95% confidence interval 2.2 to 5.9), prior preterm birth (odds ratio
2.5, 95% confidence interval 1.4 to 4.4), cervical dilatation >1 cm (odds ratio 2.9,
95% confidence interval 1.6 to 5.2), and tocolysis (odds ratio 4.5, 95% confidence
interval 2.8 to 7.2) were all independently associated with delivery before 37 weeks.
CONCLUSION: In a population of patients with symptoms, the presence of fetal fibronectin in vaginal
secretions best defines a subgroup at increased risk for delivery within 7 days; the
high negative predictive value of fetal fibronectin sampling supports less intervention
for patients with this result.(Am J Obstet Gynecol 1997;177:13-8)
Keywords
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References
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Article Info
Publication History
Accepted:
March 10,
1997
Received in revised form:
February 20,
1997
Received:
July 29,
1996
Footnotes
☆From the Departments of Obstetrics and Gynecology, Northwestern University, University of Alabama at Birmingham, University of North Carolina, Ohio State University, Hennepin County Medical Center, University of Texas at Houston, Stanford University, Good Samaritan Hospital (Phoenix), Hartford Hospital, and University of Louisville.
☆☆Funding from Adeza Biomedical.
★Reprints not available from the authors.
★★6/1/81721
Identification
Copyright
© 1997 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
