Prospective randomized controlled trial of fetal fibronectin on preterm labor management in a tertiary care center

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.     

Beta-human chorionic gonadotropin in cervicovaginal secretions and preterm delivery.

OBJECTIVES: To determine whether concentrations of beta-HCG in cervicovaginal secretions could predict spontaneous preterm birth (SPB) in asymptomatic high risk pregnancies. METHODS: A cohort study was undertaken with cervicovaginal samples collected from 540 pregnant women between 20 to 28 weeks of gestation. Levels of beta-HCG were measured by ELISA test. RESULTS: There was 3.2-fold increase in cervicovaginal beta-HCG concentrations among patients with SPB vs. term delivery. A single cervicovaginal beta-HCG > 77.8 mIU/ml, between 20 and 28 weeks' gestation, identified patients with subsequent SPB vs. term delivery with sensitivity of 87.5% (95% CI: 47.4-97.9) and a specificity of 97% (95% CI: 86.5-99.4) with positive and negative predictive values of 88.5% and 98%, respectively. Multiple logistic regression indicates that cervicovaginal beta-HCG level > 77.8 mIU/ml was an independent predictor of SPB (adjusted odds ratio 19.97, 95% CI: 10.65-37.45). Conclusions: Cervicovaginal beta-HCG is a sensitive and specific predictor of patients with subsequent preterm delivery.     

Human chorionic gonadotropin in cervicovaginal secretions as a predictor of preterm delivery.

OBJECTIVES: To determine whether human chorionic gonadotropin (hCG) detected in cervicovaginal secretions of patients with symptoms suggestive of preterm labor is a predictor of preterm birth. METHODS: Women presenting to labor and delivery with symptoms of preterm labor were invited to participate. After collecting secretions with a cotton-tipped applicator from the posterior fornix and endocervical canal, we placed the swab in a test tube containing 1 ml of normal saline. From this solution, we performed qualitative and quantitative hCG measurements. Qualitative and quantitative hCG results from women who delivered at term were compared with those delivering prior to 37 weeks' gestation. RESULTS: Samples were obtained and analyzed from 86 women at a mean (+/- standard deviation) gestational age of 30.7+/-2.9 weeks. Of the 86 subjects enrolled, 28 (32.6%) delivered preterm. A positive rapid qualitative assay from cervicovaginal secretions between 24 and 34 weeks' gestation was associated with a significant increase in the incidence of preterm delivery (relative risk 2.62, 95% confidence interval (CI) 1.38, 4.98). The likelihood ratios for a positive and negative test were 2.19 (95% CI 1.35, 3.56) and 0.51 (95% CI 0.30, 0.85) respectively. Using a cut-off of 19 mIU/ml, similar diagnostic accuracy for predicting preterm birth was obtained with the quantitative test 1.93 (95% CI 1.14, 3.26) and 0.62 (95% CI 0.40, 0.98). CONCLUSIONS: Qualitative and quantitative hCG measurements from cervicovaginal secretions may be useful predictors of preterm birth in symptomatic patients. The qualitative hCG test can be used at the bedside with results obtained in minutes.     

胎儿纤维连接蛋白评估抗生素治疗先兆早产疗效的研究

目的:探讨应用胎儿纤维连接蛋白评估抗生素治疗先兆早产的疗效。方法:选择妊娠28～33+6周先兆早产孕妇67例,随机分成两组:研究组35例,连续使用抗生素以及硫酸镁治疗3天;对照组32例,硫酸镁治疗3天,未使用抗生素。检测治疗前、治疗3天后宫颈阴道分泌物中的胎儿纤维连接蛋白(fFN)和血清中的C-反应蛋白(CRP)。结果:(1)研究组保胎成功29例,占82.8%(29/35);对照组保胎成功19例,占59.4%(19/32);比较两组保胎成功率,差异有统计学意义(P<0.05);(2)比较两组治疗后fFN阳性率和CRP值,差异均有统计学意义(P<0.05);(3)比较经治疗后fFN阳性CRP正常组与fFN阴性CRP异常组的妊娠结局,差异有统计学意义(P<0.05)。在预测早产方面,fFN敏感性为78.9%,特异性为87.5%;CRP敏感性为52.6%,特异性为79.1%。结论:胎儿纤维连接蛋白可作为评价先兆早产疗效的一项指标。     

Laparoscopic cholecystectomy in a community hospital setting.

Recently, laparoscopic cholecystectomy has become the preferred surgical procedure for removal of the gallbladder. However, many surgeons believe that the safety and efficacy have yet to be proved in the community hospital setting. To address this concern, a retrospective chart review of the initial 271 instances of inpatient laparoscopic cholecystectomy within a community hospital was undertaken. All procedures were performed by 15 general surgeons in private practice and residents in general surgery. Of the 271 patients, 11 were converted to open cholecystectomy. Surgical complications occurred in six of the 260 instances of laparoscopic cholecystectomy (2.3 percent), with only one injury to the common bile duct. Major postoperative complications occurred in 23 patients, including severe postoperative pain (nine patients), prolonged ileus (seven patients), bile leakage (three patients), retained common duct stones (two patients), respiratory failure (one patient) and postoperative myocardial infarction (one patient). The period of hospitalization ranged from one to 64 nights with a median of one night. The operative mortality rate was zero percent. Multivariate analysis identified two factors associated with an increased risk of postoperative complications. Patients 70 years of age or older and patients whose operating times were greater than one hour and 45 minutes were at increased risk for postoperative complications. We believe that these data represent the general outcomes of the laparoscopic procedure in a community hospital setting and lend support to the argument that the procedure can be performed safely and effectively in this setting.     

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.     

宫颈分泌物检测胎儿纤维连接蛋白预测早产的临床价值

目的：探讨检测先兆早产孕妇宫颈分泌物中胎儿纤维连接蛋白（fFN)在预测先兆早产的价值。方法：采用ELISA法测定86例先兆早产孕妇 颈分泌物中的fFN水平，fFN＞50μg/L为阳性组，反之为阴性组，比较两组临产时孕周的长短以及早产发生率的差异。结果：宫颈分泌物fFN阳性者临床时孕周明显短于阴性组（P＜0．01），而且80．6％发生早产，敏感性为88．5％，特异性为48．0％。结论：孕妇宫颈分泌物fFN阳性，是预测先兆早产及保胎治疗时间长短的敏感、可靠指标。     

Fetal fibronectin for evaluation of preterm labor in the setting of cervical cerclage

Objective: To evaluate the efficacy of fetal fibronectin (fFN) testing in cervical cerclage patients presenting with acute signs or symptoms of preterm labor. Methods: A total of 71 fFN tests were performed in 48 women between 23 and 34 weeks’ gestation who presented at two institutions at risk for imminent delivery with cerclage in situ. Results: The sensitivity, specificity, positive predictive value, and negative predictive value for delivery within 2 weeks of fFN testing were 100, 77, 28 and 100%, respectively. For delivery before 34 weeks sensitivity, specificity, positive predictive value, and negative predictive value were 91, 78, 56 and 97%, respectively. The relative risk of delivery <34 weeks with positive fFN was 16.7 (P < 0.001). Conclusions: For patients with cervical cerclage, fFN testing is a valid diagnostic tool in the evaluation of preterm labor.     

Fetal fibronectin in cervicovaginal secretions as a predictor of preterm birth

Objective To determine whether fetal fibronectin detected in cervicovaginal secretions of patients with symptoms suggestive of preterm labour is a predictor for preterm birth.
Design A blind prospective observational study.
Setting A teaching hospital.
Participants One hundred and forty-one women presenting to the delivery suite between 24 and 37 weeks of gestation (112 were between 24 and 34 weeks of gestation) with symptoms suggestive of preterm labour, with intact membranes and cervical dilatation of < 2 cm.
Intervention Specimens of cervicovaginal secretions were collected from the ectocervix and posterior fornix. Fetal fibronectin levels were measured by an ELISA and samples were considered positive if the level of fetal fibronectin present was ≥ 0.05 μg/ml.
Main outcome measures Gestation at birth and sampling-birth interval.
Results The preterm birth (before 3 7 weeks of gestation) rate in the population studied was 19±1%. Fetal fibronectin predicted preterm birth with sensitivity of 63%, specificity of 95±6%, positive predictive value of 77±3%, and negative predictive value of 91±6%. Analysis of the data from women at less than 34 weeks of gestation showed similar results. A negative test accurately excluded (97±9%) the chance of subsequent birth during the three weeks interval following sampling.
Conclusions The presence of fetal fibronectin in the cervicovaginal secretions of women admitted with symptoms suggestive of preterm labour indicates a significant risk for subsequent preterm birth. The absence of fetal fibronectin in this group is a very strong indication that subsequent preterm birth is unlikely to occur. Fetal fibronectin test, if combined with clinical findings, has a potentially important role in clinical management of women with symptoms suggestive of preterm labour.     

Vaginal fetal fibronectin as a predictor of spontaneous preterm delivery after multifetal pregnancy reduction

OBJECTIVE: The study was undertaken to assess the validity of vaginal fetal fibronectin assay as a screening test for spontaneous preterm delivery in asymptomatic patients who have undergone multifetal pregnancy reduction (MFPR). STUDY DESIGN: A historic cohort of 63 patients who underwent MFPR between 10 and 14 weeks of gestation was identified. All patients underwent serial vaginal fetal fibronectin sampling every 2 to 3 weeks from 22 weeks of gestation until delivery or 32 weeks of gestation. The fetal fibronectin concentration was measured by enzyme-linked immunosorbent assay, with 50 ng/mL or greater indicating a positive result. Charts were reviewed for fetal fibronectin results and pregnancy outcome data. Groups were compared by use of Fisher exact test. RESULTS: There were 13 singleton and 50 twin gestations after MFPR. A median of 4 fetal fibronectin assays were performed per patient. A total of 234 fetal fibronectin assays were performed with 222 (94.9%) negative results and 12 (5.1%) positive results. Overall, 41.3% of gestations were delivered spontaneously before 37 weeks; 7.9% were delivered before 34 weeks. The mean interval between tests was 17.8 days (+/-7.2 days). For delivery within 2 and 3 weeks of a single test, fetal fibronectin had a sensitivity of 66.7% and 50%, a specificity of 95.7% and 96.1%, a positive predictive value of 16.7% and 25%, and a negative predictive value of 99.5% and 98.6%, respectively. CONCLUSION: The fetal fibronectin test has similar validity to predict spontaneous preterm delivery in these high-risk pregnancies as in previously published cohorts.     

Vaginal fetal fibronectin as a predictor of spontaneous preterm delivery in the patient with cervical cerclage

OBJECTIVE: The purpose of this study was to assess the validity of vaginal fetal fibronectin as a screening test for spontaneous preterm birth in patients with cervical cerclage. STUDY DESIGN: A historic cohort of 117 patients who underwent cervical cerclage placement between 1996 and 2002 were identified. All patients were followed up in a maternal-fetal medicine faculty practice in a university setting. Serial fetal fibronectin samples of vaginal secretions were collected every 2 to 3 weeks, starting at 22 weeks of gestation and continuing until 32 weeks or delivery, whichever came first. RESULTS: There were 81 singleton, 23 twin, 12 triplet, and 1 quadruplet pregnancies. There were 61 ultrasound-indicated, 47 prophylactic, and 9 emergency cerclages that were placed. Most cerclages were of the modified Shirodkar type (95%) with a median gestational age at cerclage placement of 16.6 weeks. Overall, 33.3% of gestations were delivered spontaneously before 37 weeks of gestation; 17.1% of gestations were delivered spontaneously before 34 weeks. For deliveries within 2 weeks and 3 weeks of a single fetal fibronectin assessment, the test had a sensitivity of 50% and 48.3%, a specificity of 90% and 91.1%, a positive predictive value of 16.3% and 28.6%, and a negative predictive value of 97.9% and 96%, respectively. Subgroup analysis by number of fetuses (singleton, twin, and higher order multiple gestations) revealed similar values. For delivery before 34 weeks of gestation, fetal fibronectin had a sensitivity of 50%, a specificity of 78.4%, a positive predictive value of 33.3%, and a negative predictive value of 88%. CONCLUSION: This study is the first to evaluate the use of vaginal fetal fibronectin assessments to screen for preterm birth in patients who had undergone cervical cerclage procedures. We conclude that this test has similar validity to predict spontaneous preterm delivery in these high-risk pregnancies, as in previously published cohorts.     

The Value of a Single Fetal Fibronectin Assay as a Screen for Preterm Labor and Delivery

It has been shown that serial fetal fibronectin sampling has close to a 70% sensitivity in detecting preterm labor or delivery in an asymptomatic population. The objective of this study was to access the usefulness of a single vaginal fetal-fibronectin assay in the mid-second trimester from asympto matic women in predicting preterm labor and delivery. Vaginal samples were obtained from 54 consenting women who received routine prenatal care in our inner-city general obstetrical clinc. A sensitive immunoassay was used for vaginal fetal fibronectin quantitative analysis. Both patients and clinicians were blinded to fetal fibronectin results. Correlation of fetal fibronectin status with outcome was determined. The spontaneous preterm delivery rate was 19% (10/54). The presence of vaginal fetal fibronectin (< 50 ng/ml) had a sensitivity in predicting preterm labor or delivery of 19% with positive and negative predictive values of 38% and 71%, respectively. The specificity was 86% in this study. For women with preterm labor or delivery prior to 34 weeks, fetal fibronectin had a sensitivity of 75%, a specificity of 90% and a negative predictive value of 98%. These results agree with other investigators who have demonstrated that positive fetal fibronectin correlates with preterm labor or delivery within a 3-4 week period of sampling. Although clinicians may find monthly fetal fibronectin sampling impractical, sampling twice in the second trimester (22-24 weeks and 26-28 weeks) may help in identifying those women destined to deliver preterm in the gestational period with the highest neonatal risk and cost (24-32 weeks).     

The significance of a positive fetal fibronectin in the setting of a normal cervical length in twin pregnancies

To estimate the risk of preterm birth in asymptomatic women with twin pregnancies with a normal cervical length (CL) and a positive fetal fibronectin (fFN), we reviewed a retrospective cohort of twin pregnancies delivered in our practice from 2005 to 2010. Patients were screened from 22 to 32 weeks with CL and fFN at 2- to 4-week intervals. We examined 244 patients with twin pregnancies and a normal CL (>25 mm) between 22 and 32 weeks and compared outcomes based on the fFN result. Fourteen (5.7%) patients had a positive fFN and 230 (94.3%) patients had a negative fFN. Positive fFN was associated with an increased the risk of spontaneous preterm birth < 37 weeks (85.7% versus 38.3%, p = 0.001), < 35 weeks (50% versus 11.8%, p < 0.001), < 34 weeks (35.7% versus 6.9%, p < 0.001), and < 32 weeks (21.4% versus 2.2%, p < 0.001). On adjusted analysis, a positive fFN was independently associated with preterm birth < 32 weeks (odds ratio 6.8, 95% confidence interval 1.42, 32.2) and gestational age at delivery (p = 0.001). In the setting of a normal CL, a positive fFN is significantly associated with preterm birth in asymptomatic twin pregnancies. Contingency model screening of fFN in asymptomatic twin pregnancies solely based on CL evaluation may fail to identify a cohort of at-risk patients.     

Multichannel mapping of fetal magnetocardiogram in an unshielded hospital setting

OBJECTIVES: To evaluate the feasibility of unshielded in-hospital multichannel mapping of fetal magnetocardiogram (FMCG), with a 36-channel system for standard adult magnetocardiographic (MCG) recordings, and its reliability according to the recommended standards for FMCG. METHODS: FMCG was ambulatory mapped with a 36-channel MCG system, in six normal pregnancies at different gestational ages. MCG analysis included adaptive digital filtering of 50 Hz, signal averaging, reconstruction of magnetic field distribution (MFD) and source localization. Fixed Point Independent Component Analysis algorithm (FastICA) was used to reconstruct the FMCG, separating them from maternal contamination and noise. RESULTS: The quality of FMCG recorded after the 32nd gestational week and reconstructed with FastICA was close to FMCG obtained in shielded rooms, and good enough to measure cardiac intervals and heart rate variability parameters. In two cases, reconstruction of the MFD during the QRS allowed three-dimensional localization of ventricular sources. CONCLUSIONS: A first demonstration has been given that multichannel mapping of FMCG can be performed in unshielded clinical environments, with resolution good enough for contactless assessment of fetal cardiac electrophysiology. FastICA processing on unshielded FMCG, recorded after the 32nd week, provided beat-to-beat analysis and heart rate variability assessment. Further work is needed to improve signal reconstruction in early pregnancy.     

Cell-free fetal DNA and adverse outcome in low risk pregnancies

Objective

To analyze in a large prospective cohort study of low risk pregnancies whether cell-free fetal (cff) DNA in maternal plasma of the second trimester might be associated with the development of preeclampsia, preterm delivery, and small for gestational age.

Study design

A subset of a large prospective cohort study in serological RhD negative pregnant women with RHD positive fetuses was used. Cff DNA was determined through the detection of RHD specific sequences with real-time PCR.

Results

In 611 pregnancies, rates of 7.2% preeclampsia, 1.6% preterm birth ≤32, 2.9% ≤34, and 12.4% ≤37 weeks of gestation, 5.7% of small for gestational age <5th percentile, and 8.2% <10th percentile were observed. For none of these risk groups an association with cff DNA could be established.

Conclusion

Cff DNA in maternal plasma of the second trimester was not found to be a marker for an adverse pregnancy outcome in low risk pregnancies.     

Cervicovaginal fibronectin improves the prediction of preterm delivery based on sonographic cervical length in patients with preterm uterine contractions and intact membranes

OBJECTIVE: The purpose of this study was to examine the diagnostic performance of ultrasonographic measurement of the cervical length and vaginal fetal fibronectin determination in the prediction of preterm delivery in patients with preterm uterine contractions and intact membranes. STUDY DESIGN: Ultrasound examination of the cervical length and fetal fibronectin determination in vaginal secretions were performed in 215 patients admitted with preterm uterine contractions (22-35 weeks) and cervical dilatation of 相似文献