Fetal Fibronectin Testing Research Articles

Obstetrician-gynecologists' knowledge of preterm birth frequency and risk factors

Objectives. To assess obstetrician-gynecologists' knowledge of preterm birth, including prevalence, risk factors, and utility of various tests in predicting increased risk.Methods. A questionnaire was mailed to 1193 members of the American College of Obstetricians and Gynecologists.Results. The response rate was 59%. The majority of respondents were familiar with basic preterm birth prevalence rates. However, 21% underestimated the proportion of women with presumptive preterm labor in whom preterm birth will not occur. The majority (55%) overestimated the proportion of preterm births accounted for by multiples. Twelve percent indicated bed rest as a proven method for improving newborn outcome. Respondents were fairly accurate as to which factors produce the biggest increased risk of spontaneous preterm labor or rupture of membranes; however, they tended to overestimate the risk associated with smoking, hypertension, and non-gestational diabetes. They tended to underestimate, or were unsure of, the predictive value of positive fetal fibronectin (fFN) test results or short cervical length.Conclusions. Obstetrician-gynecologists' basic knowledge concerning preterm birth prevalence and risk factors was adequate. However, they tended to overestimate the risk associated with various maternal factors and underestimate the predictive value of various test results.

Improved Management in Threatened Preterm Labor With Rapid Fetal Fibronectin Testing

An estimated 80% of women with threatened preterm labor will go on to deliver at term. Nevertheless, the sequelae of preterm delivery are so threatening that affected women routinely are assessed by ultrasound and receive steroids as well as acute tocolytic therapy in the hospital. Estimating levels of fetal fibronectin (fFN) clearly has some predictive value, notably a negative predictive value of 99.5% for delivery within 1 week. Until now, fFN has been estimated using an enzyme-linked immunosorbent assay (ELISA), an expensive and time-consuming procedure. A new optical system, the TLIIq photometer, has a turnaround time of only 20 minutes and appears to be as accurate as the ELISA. Studies done to date to evaluate the TLIIq have given mixed results. In a 3-month period before the TLIIq system became available, 11 women met criteria for fFN testing. Gestational ages ranged from 27 to 33 weeks and gestational ages at delivery from 30 to 40 weeks. Nine other women, tested in a second 3-month period using the TLIIq system, had initial gestational ages from 25 to 34 weeks and gestational ages at delivery of 30 to 41 techniques. The rate of ultrasound study fell from 100% to 78% in the later period. Steroids were administered to 82% and 56% of women, respectively, and tocolytic therapy to the same proportions. The average hospital stay declined from 3.8 to 2.5 days. Of 6 TLIIq-negative women, 4 had ultrasound studies, 2 received steroids, 2 received tocolytic therapy, and the time in the hospital averaged 1.7 days. These prospectively collected findings, although on a small scale, suggest that a rapid test for fFN has the potential to limit time in the hospital for women with threatened preterm labor and thereby to confer emotional and social benefit.

Performance of cervicovaginal fetal fibronectin in a community hospital setting

To assess the accuracy of vaginal fetal fibronectin (FFN) as a screening test for preterm delivery in a community hospital. A prospective cohort of patients at high risk for preterm delivery at a community hospital underwent testing with FFN over a 15 month-period (March 2004-May 2005). Indications for testing were preterm labor, multiple pregnancies, cervical shortening, and cerclage. Pregnancy characteristics were retrieved on all women with positive FFN results and controls in a 1:2 ratio. Outcome variables included interval to delivery; length of hospital stay; and rates of preterm delivery <37 weeks. In the presence of serial FFN testing, only the initial result was used for calculation of diagnostic indices. Statistical analysis utilized t-test, Fisher's exact test and logistic regression analysis to control for gestational age at testing, with P < 0.05 or odds ratio (OR) with 95% confidence interval (CI) not inclusive of the unity considered significant. Two hundred and fifty seven FFN tests were performed in 230 women, of which 33 (14.3%) had positive FFN results. Duration of hospital stay was significantly shorter for patients with negative than positive results (8 h vs. 2.1 days, P = 0.011). Women with positive FFN were more likely to deliver within 14 days (OR = 6.5, 95% CI 1.4; 30.7), within 21 days (OR = 4.8; 95% CI 1.4; 16.6), before 34 weeks (OR = 5.0, 95% CI 1.7; 14.8) and before 37 weeks (OR = 3.1; 95% CI 1.3; 7.1) than women with negative results. A negative FFN result provides enough reassurance to allow shorter hospital stay. In a real-world setting (a community hospital with a population heterogeneous for risk factors for preterm delivery, and in a non-protocol setting) the performance of FFN testing closely mirrors that obtained in academic institutions, where the test was studied in more uniform populations under strict protocols. The performance of vaginal fibronectin in patients with heterogeneous risk factors for preterm delivery closely mirrors that obtained in studies conducted in populations with homogeneous risk factors.

The impact of fetal fibronectin testing for women with symptoms of preterm labour in routine clinical practice within a New Zealand population

To perform a comparative analysis of antenatal management received according to the results of cervico-vaginal fetal fibronectin (fFN) testing, and to review preterm delivery rates and fFN predictive values within a New Zealand population of women presenting with threatened preterm labour. Case note review of all fFN tests performed at Middlemore Hospital, South Auckland from August 2003 to March 2005 (n = 199). Data collected included risk factors for preterm delivery, signs and symptoms at presentation, antenatal management received after fFN test and outcome and delivery details. Positive and negative fFN results were compared. Women with a positive fFN were more likely to receive antenatal corticosteroids (96.4 vs 4.7% RR 8.74 (95% CI 5.40-14.17)) and tocolysis (71.4 vs 2.4% RR 8.10 (95% CI 4.49-14.59)) and to be admitted antenatally (96.4 vs 54.4% RR 1.77 (95% CI 1.50-2.10)) with a higher mean cost of treatment (967.47 NZ dollars vs 335.27 NZ dollars P < 0.05). Rates of delivery < 34 weeks were higher in those with a positive fFN (41.9 vs 0.7% RR 62.06 (95% CI 8.43-457.14)). Women with a positive fFN result received different treatment to those with a negative fFN. Use of fFN test in routine clinical practice allows management and resources to be targeted more appropriately and may limit unnecessary interventions.

Sonographic Measurement of Cervical Length ad Fetal Fibronectin Testing in Threatened Preterm Labor

When measured in women with preterm contractions, both the presence or absence of fetal fibronectin in cervicovaginal secretions and sonographically measured cervical length have been reported to distinguish true from false labor, essentially between women who will and will not deliver within the next 7 days. The present study, which prospectively enrolled 195 women with singleton pregnancies who were seen at 24 to 36 weeks gestation, attempted to determine whether combining these 2 tests is more predictive than either test by itself. Participants presented with regular painful uterine contractions but were less than 3 cm dilated and had intact membranes. Fetal fibronectin concentrations were measured by immunoassay in cervicovaginal secretions taken from the posterior fornix or endocervix followed by digital assessment of cervical dilation. Transvaginal sonography was then performed to measure cervical length. The clinician caring for each patient was blinded to the test results. The women presented at a median gestational age of 31 weeks; 19 of them (9.7%) delivered within 1 week. The rate of preterm delivery was 51.4% in women whose cervical length was less than 15 mm and 0.6% in those having a longer cervix. Similarly, the preterm delivery rate for women with positive fetal fibronectin was 21.2% compared with 0.9% for fibronectin-negative women. The positive and negative likelihood ratios for delivery within 1 week were 9.8 and 0.05, respectively, for a cervical length less than 15 mm, and 2.6 and 0.08 for a positive fibronectin test. The rate of delivery within 7 days increased exponentially as cervical length decreased. Cervical length correlated inversely with positive fetal fibronectin; the shorter the cervix, the more likely that fibronectin was positive. On multiple logistic regression analysis, the only factor that independently and significantly predicted preterm delivery was cervical length. Excluding cervical length, positive fibronectin contributed significantly to predicting delivery within 1 week. Other predictive factors included Afro-Caribbean ethnicity and gestational age at the time of presentation. Analysis of receiver-operating characteristic curves indicated that predictions based on cervical length were better than those provided by the fibronectin test. In women presenting with threatened preterm labor, a short cervix on sonography more accurately identifies those at high risk than does the presence of fetal fibronectin in cervicovaginal secretions. Measurements of cervical length can provide a basis for hospitalizing women and administering a tocolytic agent or steroid. If sonography is not available, risk status may be inferred from ethnic origin, gestational age, and the results of a fetal fibronectin test.

Improved management in threatened preterm labour with rapid fetal fibronectin testing

Recently, a new rapid system for fetal fibronectin (fFN) analysis (TLI(IQ)) has been developed with accuracy equal to the gold standard, ELISA (enzyme-linked immunosorbent assay) testing. The objective of this quality improvement project was to confirm that a reduction in intervention and a reduced length of stay did occur, as expected, after the testing of fFN was introduced at a tertiary referral hospital (National Women's Hospital) for women in threatened preterm labour. There was a reduction in investigation and treatment of women after fFN was introduced. The average length of stay reduced from 3.8 to 2.9 days after testing was introduced. For the women who were fFN negative, the average length of stay was 1.7 days.

Sonographic measurement of cervical length and fetal fibronectin testing in threatened preterm labor

In women presenting with threatened preterm labor, both fetal fibronectin and sonographic measurement of cervical length have been shown to distinguish between true and false labor. The aim of this study was to determine whether the combination of both tests provides a better prediction than the individual tests alone. We examined 195 women with singleton pregnancies presenting at 24-36 (median 31) weeks of gestation with regular and painful uterine contractions, intact membranes and cervical dilatation of less than 3 cm. On admission to the hospital fetal fibronectin positivity in cervicovaginal secretions was determined and transvaginal sonographic measurement of cervical length was carried out. The results were not made available to the attending obstetrician. The primary outcome measure was delivery within 7 days of presentation. Delivery within 7 days occurred in 51.4% (18 of 35) of those with cervical length below 15 mm and 0.6% (1 of 160) of those with cervical length of 15 mm or more, in 21.2% (18 of 85) of the fibronectin positive group and in 0.9% (1 of 110) of the fibronectin negative group. There was a significant association between cervical length and the incidence of fibronectin positivity (r = -0.921, P = 0.003). Logistic regression analysis demonstrated that the only significant contributor to the prediction of delivery within 7 days was cervical length, with no significant contribution from fibronectin positivity, ethnic origin, maternal age, gestational age, body mass index, parity, previous history of preterm delivery, cigarette smoking, or use of tocolytics. In women with threatened preterm labor assessment of fetal fibronectin in cervicovaginal secretions does not improve the prediction of delivery within 7 days provided by the sonographic measurement of cervical length.

The Evaluation of the Fetal Fibronectin Test for Prediction of Preterm Delivery in Symptomatic Patients

ObjectiveThis study was conducted to evaluate the usefulness of testing for fetal fibronectin (fFN) to rule out the diagnosis of preterm labour in symptomatic patients in a Canadian setting. MethodsThis was a prospective, blinded clinical evaluation of fFN testing in women presenting with threatened preterm labour at between 24 and 34 weeks’ gestation at two Canadian tertiary care centres. ResultsOf the 149 women tested, 32 had a positive fFN test. In the total patient population, 10.1% delivered within seven days of testing, and 18.2% delivered prior to 34 weeks. A negative fFN result was associated with a 97.4% likelihood of delivering more than seven days after testing and with a 91.4% chance of delivering after 34 weeks. ConclusionThe fFN test appears to provide useful information in the risk assessment of Canadian women presenting with symptoms compatible with preterm labour. A negative test has a high predictive value for delivering more than seven days after presentation.

Implementation of fetal fibronectin (FFN) testing in a large private practice hospital is safe and effective for the diagnosis and management of preterm labor (PTL)

Implementation of fetal fibronectin (FFN) testing in a large private practice hospital is safe and effective for the diagnosis and management of preterm labor (PTL)

A comparison of speculum and non-speculum collection of cervicovaginal swab specimens for fetal fibronectin testing

A comparison of speculum and non-speculum collection of cervicovaginal swab specimens for fetal fibronectin testing

Cervical fetal fibronectin as a predictor of first trimester pregnancy outcome in unexplained recurrent miscarriage

Objective To determine whether cervical fetal fibronectin is a reliable predictor of first trimester pregnancy outcome in patients with unexplained recurrent miscarriage. Study design A prospective observational study was carried out on 49 pregnant women with a history of unexplained recurrent miscarriage. In all participants the presence of fetal fibronectin in the cervical secretion was determined with a qualitative rapid immunoassay. The outcome of the first trimester pregnancy was recorded a successful outcome was a pregnancy that progressed beyond 12 weeks of gestation; a miscarriage referred to a pregnancy loss in the first 12 weeks. Results Of the 49 subjects screened, fetal fibronectin was positive in 17 and negative in 32. Overall, 14 pregnancies resulted in fetal loss before the 12th week of gestation. Fetal cervical fibronectin was positive in 6 of the 14 patients who miscarried and in 11 of the 35 in whom outcome was successful. As predictor of first trimester pregnancy outcome the test had a sensitivity and a specificity of 43% and 69% and positive and negative predictive values of 35%, and 75%, respectively. Subgroup analysis by number of previous miscarriages and maternal age gave similar values. Conclusion This study examines the possible value of cervical fetal fibronectin in predicting first trimester pregnancy outcome. We conclude that the occurrence of positive or negative fetal cervical fibronectin test has only limited predictive value and therefore its use cannot be considered for clinical application.

Does Availability of Fetal Fibronectin Testing in the Management of Threatened Preterm Labour Affect the Utilization of Hospital Resources?

Objectives: To examine how the availability of fetal fibronectin testing affects the utilization of hospital resources.Methods: A comparison of the rates, duration, and costs of hospitalization for a prospective cohort of women who presented with preterm labour after fetal fibronectin (Ffn) testing became available, and a historical baseline cohort who presented with preterm labour before fetal fibronectin testing was available. The study included singleton pregnancies presenting between 24 and 34 weeks’ gestation with signs and symptoms of preterm labour. The women in each study cohort presented during a designated 20-week period.Results: We examined the records of 116 subjects with comparable gestational age distributions in each 20-week period. During the study period when Ffn testing was available, 51 tests were performed. Four tests were invalid, and 12 subjects who were tested did not meeting the inclusion criteria. Admissions for preterm labour in the study period were significantly less than in the baseline cohort (12.1% vs. 24.1%, P = 0.03), with no difference in preterm births (8.6% vs. 7.8%). The mean length of stay per patient with preterm labour declined from 5.2 days to 0.6 days (P < 0.0001), and the mean cost per patient with preterm labour declined from $3666 to $581 (P < 0.0001). In the 20-week study period, there was a reduction in total length of hospital stay from 145 to 28 days, with an overall reduction in total cost from $102 660 to $26 169.Conclusion: The availability of Ffn testing was associated with a reduction in hospital admissions, length of hospital stay, and overall hospital costs in the management of threatened preterm labour.

Sterile Speculum Exams & fFN Collection

The negative predictive value of the fFN test for symptomatic women is 99.2%, meaning that less than one woman out of 100 with a negative result will deliver in the next 14 days. The positive predictive value of the test is 16.7%, meaning that out of 100 positive fFN tests almost 17 women will deliver within 14 days, so more people will be tocolyzed than actually need to be. Fetal Fibronectin testing may be useful in women with symptoms of pre‐term labor to identify those with negative values, and a reduced risk of pre‐term birth, thereby avoiding unnecessary intervention.

Fetal fibronectin as predictor of successful induction of mid‐trimester abortion

Fetal fibronectin (FFN) in cervical secretion is one of the most effective markers of pre-term and term delivery. The presence of FFN in cervicovaginal secretions has recently been shown to reflect cervical state and an uncomplicated induction of labor at term. This study was designed to determine whether FFN could be a biochemical marker to predict the response to prostaglandins in early mid-trimester abortion. The presence of cervical FFN was evaluated by means of qualitative rapid immunoassay in 270 patients, who required second trimester termination of pregnancy at the Department of Gynecology and Obstetrics, University of Naples 'Federico II'. According to the standard protocol of our unit, women received 1.0 mg of gemeprost intravaginally at 3-hr intervals up to a maximum of five suppositories. The induction-to-abortion interval and the percentage of successful abortions within 24 hr in women in the positive FFN group (n=19) were compared with those in the negative FFN group (n=251). FFN in the cervical secretions was present in seven women (10.2%) at 16-weeks gestation, in seven women (7.5%) at 17-weeks gestation, and in five women (4.5%) at 18-week gestation. Final termination rates were 13 (68.4%) in the fibronectin-positive group and 177 (70.5%) in the fibronectin-negative group. The median abortion interval was similar (14.7 versus 15.1 hr) in both groups. A positive cervical fetal fibronectin test does not predict a successful medical termination of pregnancy in second trimester abortion. In this setting, the role of fetal cervical fibronectin in cervical ripening is, therefore, questionable.

“Blind” Vaginal Fetal Fibronectin as a Predictor of Spontaneous Preterm Delivery

To assess the accuracy of vaginal fetal fibronectin sampling without use of a sterile speculum examination as a screening test for predicting spontaneous preterm birth. A historical cohort of patients who were followed up with serial fetal fibronectin testing between 1998 and 2001 was identified. All patients were considered to be at high risk for preterm delivery and were screened with fetal fibronectin testing without using a speculum at 2- to 3-week intervals from 22 weeks to 32 weeks of gestation. Charts were reviewed for fetal fibronectin results and pregnancy outcome data. Groups were compared using chi(2) analysis or Fisher exact test with significance defined as P < .05. A total of 1,396 fetal fibronectin tests from 416 pregnancies were performed via the "blind" sampling technique. Overall, 24.9% of pregnancies delivered spontaneously before 37 weeks; 9.1% delivered spontaneously before 34 weeks. For delivery before 34 weeks of gestation, the test had a sensitivity of 44.7%, a specificity of 88.4%, a positive predictive value of 27.9%, and a negative predictive value of 94.1%. For delivery within 14 and 21 days of a single fetal fibronectin assessment, the test had a sensitivity of 52% and 45.5%, a specificity of 94.5% and 94.9%, a positive predictive value of 14.6% and 22.5%, and a negative predictive value of 99.1% and 98.2%, respectively. "Blind" vaginal fetal fibronectin sampling has high negative predictive values and specificities in predicting spontaneous preterm birth. II-2.

Fetal fibronectin test predicts delivery before 30 weeks of gestation in high risk women, but increases anxiety

To assess efficacy of cervico-vaginal fetal fibronectin as a predictor of spontaneous preterm birth in a high risk antenatal population, and to evaluate the psychological impact of fetal fibronectin testing. An observational study. The antenatal clinic at a tertiary referral hospital. One hundred and forty-six pregnant women with known risk factors for spontaneous preterm birth. Women designated as 'at risk' for preterm delivery by clinical history were screened for fetal fibronectin at 24 and again at 27 weeks of gestation. Anxiety levels were assessed by questionnaire and compared with anxiety levels of 206 low risk women also tested for fetal fibronectin. Fetal fibronectin results were disclosed to the woman and her clinician. Maternal anxiety and efficacy of the 24-week fetal fibronectin test to predict delivery before 30, 34 and 37 weeks of gestation. Maternal anxiety was higher pretesting in those at high risk compared with low risk women undergoing the test. Among the high risk women, anxiety was raised to clinically significant levels in those receiving a positive fetal fibronectin screening test result. In all women, 5%, 9% and 21% delivered <30, <34 or <37 weeks of gestation, respectively. Nine percent (n= 13) tested positive for fetal fibronectin at 24 weeks. Predictive power for fetal fibronectin (24 weeks) was greatest for delivery <30 weeks of gestation, with a likelihood ratio of 15 for a positive test (6/13 positive women delivered before 30 weeks). Fetal fibronectin was most efficient as a predictor of preterm spontaneous delivery <30 weeks of gestation, but was associated with high levels of anxiety.

Fetal fibronectin (FFN) testing in symptomatic patients for preterm labor and mcdonald cerclage

ObjectiveThe purpose of this study was to assess the utility of vaginal fFN screening in symptomatic patients with a McDonald cerclage.Study designA retrospective cohort of patients who underwent McDonald cerclage from 1998-2004 was performed. Patients tested with fFN due to increased pelvic pressure or symptomatic uterine contractions were included in the analysis.ResultsA total of 163 fFN tests were performed in 90 eligible patients, including 68 singleton and 22 twin pregnancies. Data were analyzed to examine for delivery in ≤2 weeks from the time of performance of a fFN test (Table I). One singleton pregnancy with a negative test was excluded from this analysis for non-spontaneous delivery within 2 weeks. In the setting of a McDonald cerclage and symptoms of preterm labor, fFN testing showed a specificity of 90.6 % and negative predictive value of 98.0% for delivery in a 2 week period. A separate analysis was performed to evaluate delivery ≤34 weeks (Table II). Four patients were excluded for delivery for medical indications prior to 34 weeks. For delivery prior to 34 weeks, fFN had a sensitivity of 50%, specificity of 87.5%, negative predictive value of 95.9%, and positive predictive value of 23.1%.ConclusionTable IDelivery ≤2 weeks of fFN testingDelivery ≤2 wkDelivery >2 wk+fFN015−fFN3144 Open table in a new tab Table IIDelivery at ≤34 weeksDelivery ≤34 wkDelivery >34 wkAll fFNs −370Any fFN +310 Open table in a new tab ObjectiveThe purpose of this study was to assess the utility of vaginal fFN screening in symptomatic patients with a McDonald cerclage. The purpose of this study was to assess the utility of vaginal fFN screening in symptomatic patients with a McDonald cerclage. Study designA retrospective cohort of patients who underwent McDonald cerclage from 1998-2004 was performed. Patients tested with fFN due to increased pelvic pressure or symptomatic uterine contractions were included in the analysis. A retrospective cohort of patients who underwent McDonald cerclage from 1998-2004 was performed. Patients tested with fFN due to increased pelvic pressure or symptomatic uterine contractions were included in the analysis. ResultsA total of 163 fFN tests were performed in 90 eligible patients, including 68 singleton and 22 twin pregnancies. Data were analyzed to examine for delivery in ≤2 weeks from the time of performance of a fFN test (Table I). One singleton pregnancy with a negative test was excluded from this analysis for non-spontaneous delivery within 2 weeks. In the setting of a McDonald cerclage and symptoms of preterm labor, fFN testing showed a specificity of 90.6 % and negative predictive value of 98.0% for delivery in a 2 week period. A separate analysis was performed to evaluate delivery ≤34 weeks (Table II). Four patients were excluded for delivery for medical indications prior to 34 weeks. For delivery prior to 34 weeks, fFN had a sensitivity of 50%, specificity of 87.5%, negative predictive value of 95.9%, and positive predictive value of 23.1%. A total of 163 fFN tests were performed in 90 eligible patients, including 68 singleton and 22 twin pregnancies. Data were analyzed to examine for delivery in ≤2 weeks from the time of performance of a fFN test (Table I). One singleton pregnancy with a negative test was excluded from this analysis for non-spontaneous delivery within 2 weeks. In the setting of a McDonald cerclage and symptoms of preterm labor, fFN testing showed a specificity of 90.6 % and negative predictive value of 98.0% for delivery in a 2 week period. A separate analysis was performed to evaluate delivery ≤34 weeks (Table II). Four patients were excluded for delivery for medical indications prior to 34 weeks. For delivery prior to 34 weeks, fFN had a sensitivity of 50%, specificity of 87.5%, negative predictive value of 95.9%, and positive predictive value of 23.1%. ConclusionTable IDelivery ≤2 weeks of fFN testingDelivery ≤2 wkDelivery >2 wk+fFN015−fFN3144 Open table in a new tab Table IIDelivery at ≤34 weeksDelivery ≤34 wkDelivery >34 wkAll fFNs −370Any fFN +310 Open table in a new tab

Fetal fibronectin testing for suspected preterm labour in Nova Scotia

Fetal fibronectin testing for suspected preterm labour in Nova Scotia

Cervicovaginal interleukin-6, tumor necrosis factor-alpha, and interleukin-2 receptor as markers of preterm delivery.

Preterm delivery is a common obstetric problem (1), and infants born prematurely are at increased risk for long-term disability and death (2). Clinical indicators of preterm delivery are neither sensitive nor specific (3). Fetal fibronectin (fFN) testing of cervicovaginal fluid is the only Food and Drug Administration-cleared test for prediction of preterm delivery. A negative fFN test ( 99% negative predictive value for delivery within 7 or 14 days of testing (4)(5). The negative result enables physicians to avoid unnecessary interventions, but the fFN test is costly (more than $100 per test). Cytokines have been investigated as biomarkers of impending preterm delivery and may favor preterm birth by stimulating prostaglandin synthesis (6)(7). Increased serum and amniotic fluid concentrations of several cytokines have been reported in women with preterm labor (8)(9)(10)(11)(12). The use of cervicovaginal fluid has been suggested as an alternative to amniotic fluid testing because this fluid is thought to be released through mechanical or inflammation-mediated damage to the membranes or placenta before birth (13). Cytokines may be released into cervicovaginal fluid during the breakdown of the chorio-decidual adhesion or from an inflammatory reaction in the same area. Few studies have been performed on symptomatic women (14)(15)(16)(17)(18)(19)(20). The objective of this study was to examine the potential usefulness of cervicovaginal interleukin-6 (IL-6), tumor necrosis factor-α (TNFα), and interleukin-2 receptor (IL-2R) in the prediction of delivery in symptomatic women within 14 days of testing. This was a retrospective cohort study of samples for physician-ordered cervicovaginal fFN tests received by the Barnes-Jewish Hospital laboratory between February 2001 and December 2002. Cervicovaginal fluid was …

Does fetal fibronectin use in the diagnosis of preterm labor affect physician behavior and health care costs? A randomized trial

Objective The purpose of this study was to determine whether a knowledge of fetal fibronectin results affects patient treatment and health care costs. Study design Women between 24 and 34 weeks of gestation with a singleton pregnancy and preterm uterine contractions were eligible for enrollment. Once informed consent was given, a fetal fibronectin specimen was obtained, and women were assigned randomly into 2 groups. In 1 group, results of the fetal fibronectin test were available; in the other group, results were not available. The use of inpatient and outpatient health care resources subsequent to enrollment was ascertained through the use of medical records, hospital billing data, and patient interviews. This study was powered to allow the detection in the fetal fibronectin group of a 20% reduction in total health care–related costs. Results The 2 groups were similar with respect to maternal age, parity, race, cervical examination at admission, and estimated gestational age at enrollment and at delivery. Women who did not have fetal fibronectin results available were no different than those women who did with respect to initial length of labor and delivery observation (median, 4 hours vs 3 hours), hospital admission (28% vs 26%), tocolysis (18% vs 16%), cessation of work (27% vs 26%), or total health care–related costs (log mean ± SD, 7.6 ± 1.2 vs 7.5 ± 1.1). Conclusion In this study population, the use of fetal fibronectin did not affect physician behavior or health care costs related to preterm contractions.