General obstetrics and gynecology: obstetrics
Prospective randomized controlled trial of fetal fibronectin on preterm labor management in a tertiary care center

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Abstract

Objective

The purpose of this study was to investigate the effect of the rapid fetal fibronectin on the length of hospital stay and the use of preterm labor interventions in a tertiary care center.

Study design

Women who were seen in the Labor and Delivery Unit with symptoms of preterm labor were assigned randomly to receive fetal fibronectin (n = 46 women) or to preterm labor management without fetal fibronectin (n = 51 women). Physicians were not blinded to the result; groups were compared.

Results

There was no difference between groups in demographic or obstetric characteristics, the hours spent in labor and delivery, the number of women who were admitted to the antepartum service, the length of stay, or medical interventions. When the results for women with a negative fetal fibronectin test were compared to women with a positive fetal fibronectin test, a significant difference was found in admissions to the antepartum service (P = .032) and the length of stay (P = .008).

Conclusions

A negative fetal fibronectin test was associated with fewer admissions to the antepartum ward and a shorter length of stay.

Section snippets

Material and methods

The study was approved by the University of Iowa Hospitals and Clinics Institutional Review Board. Women with signs and symptoms of preterm labor (uterine contractions and/or cervical change) who were examined at the University of Iowa Labor and Delivery Unit or those women who were transferred already receiving tocolytic medications were eligible for the study. Inclusion criteria were gestational age between 23 and 34 weeks, >16 years of age, cervical dilatation of ≤3 cm for primigravid women,

Results

A total of 110 patients were enrolled into the study between August 2000 and May 2002. Four women were excluded because of readmissions, 1 woman was found to have preterm premature rupture of membranes, 1 woman had an urgent cesarean delivery, and data from 1 woman was unable to be obtained because of blood in the vagina. Three women were assigned randomly to receive the fFN test but were discharged before it could be performed. One woman was found to be at >34 weeks of gestation, 1 woman was

Comment

In 1991, Lockwood et al4 published the first study in which the presence of fFN in preterm labor patients was associated with preterm delivery. Since then, several investigators have studied the ability of fFN to predict preterm delivery in women with symptoms of preterm labor and have found a negative predictive value for delivery within 1 week near 99% and 95% for 2 weeks.5., 6. These studies relied on the fFN enzyme immunoassay with a minimum turnaround time of 24 hours. Our study used the

References (8)

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    Publication bias, which was assessed with the use of Begg’s and Egger’s tests, was not significant (P = .84 and .91, respectively). Authors of 4 trials were able to provide us additional unpublished data from their studies.7,9,10,12 Table 1 shows the characteristics of the included trials.

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Supported by Process Improvement Grant, University of Iowa.

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