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Objective Fetal fibronectin (fFN) testing and transvaginal ultrasound (TVUS) are diagnostic tools used to predict impending spontaneous preterm birth (sPTB) among women presenting with preterm labor (PTL). We evaluated the association between fFN testing or TVUS cervical length (CL) measurement in predicting sPTB, respiratory distress syndrome (RDS), neonatal intensive care unit (NICU) admission, and sPTB-related costs. Study Design We conducted a retrospective cohort study using data from the Kaiser Permanente Southern California electronic health system (January 1, 2009–December 31, 2020) using diagnostic and procedure codes, along with a natural language processing algorithm to identify pregnancies with PTL evaluations. PTL evaluation was defined as having fFN and/or TVUS assessment. Outcomes were ascertained using diagnostic, procedural, and diagnosis-related group codes. Multivariable logistic regression assessed the association between fFN and/or TVUS results and perinatal outcomes. Results Compared with those without PTL evaluations, those with positive fFN tests had higher adjusted odds ratio (adj.OR) for sPTB (2.95, 95% confidence interval [CI]: 2.64, 3.29), RDS (2.34, 95% CI: 2.03, 2.69), and NICU admission (2.24, 95% CI: 2.01, 2.50). In contrast, those who tested negative had lower odds for sPTB (adj.OR: 0.75, 95% CI: 0.70, 0.79), RDS (adj.OR: 0.67, 95% CI: 0.61, 0.73), and NICU admission (adj.OR: 0.74, 95% CI: 0.70, 0.79). Among those with positive fFN results, the odds of sPTB was inversely associated with CL. Health care costs for mothers and neonates were lowest for those with fFN testing only. Conclusion This study demonstrates that positive fFN results were associated with an increased odds of sPTB, RDS, and NICU admission and the association with sPTB was inversely proportional to CL. Additionally, negative fFN results were associated with decreased odds of sPTB, RDS, and NICU admissions. fFN testing may predict these and other sPTB-related adverse outcomes hence its utility should be explored further. Moreover, fFN testing has some cost savings over TVUS. Key Points Patients with positive fFN tests had higher odds of sPTB, RDS, and NICU admission. Inverse relationship between sPTB and CL among those with positive fFN tests was observed. Health care costs for mothers and neonates were lowest for those with fFN testing only. [ABSTRACT FROM AUTHOR]

• Women with twin gestations who delivered preterm had significantly higher HR compared to those who did not delivery preterm and significantly lower IOS and EOS. • Incidences of HR < 50 % and < 35 % were statistically significantly higher in women who delivered preterm compared to those who did not (p < 0.01). To evaluate the prediction performance of E-Cervix™ for preterm birth in twin pregnancies with threatened preterm labor. This was a single-center retrospective cohort study of twin pregnancies presenting to obstetrics triage for threatened preterm labor (PTL) between 23 0/7 – 33 6/7 weeks who received screening for PTL with transvaginal ultrasound cervical length (TVU CL) and cervical elastography with E-Cervix™ at the time of triage. Cervical elastography parameters were examined and compared between women who delivered preterm and those who did not. The quantification of cervical strain was calculated by a data analysis system that directly analyzes raw data from the region of interest (ROI) and described as hardness ratio (HR), mean strain level within 1 cm from internal (IOS) and external (EOS) os. 63 twin gestations without prior preterm birth and with threatened PTL between 23 0/7 – 33 6/7 weeks of gestation were included in the study. 27 (42.9 %) had cervical length < 25 mm, and were admitted for true PLT. Out of the 36 women with cervical length ≥ 25 mm, 6 (16.7 %) were admitted. Women with threatened PTL had significantly higher HR compared to those with true PTL (p < 0.01), and significantly lower IOS and EOS. Women who delivered preterm had significantly higher HR compared to those who did not delivery preterm and significantly lower IOS and EOS, in overall cohort, and in the subset of women with true PTL. Incidences of HR < 50 % and < 35 % were statistically significantly higher in women who delivered preterm compared to those who did not (p < 0.01). Cervical elastography with E-Cervix™ may be useful for assessment of twin gestations presenting to obstetrics triage for threatened PTL. [ABSTRACT FROM AUTHOR]

Vasa previa is a pregnancy complication that occurs when unprotected fetal blood vessels traverse the cervical os, placing the fetus at high risk of exsanguination and fetal death. These fetal vessels may be compromised by fetal movement and compression, leading to poor oxygen distribution and asphyxiation. Diagnostic tools for vasa previa management and preterm labor (PTL) include transvaginal ultrasound, cervical length (CL) surveillance and use of fetal fibronectin (FFN) testing. These tools can prove to be quite useful as they allow for lead time in the prediction of PTL and spontaneous rupture of membranes which can result in devastating outcomes for pregnancies affected by vasa previa. We conducted a literature review on vasa previa management and the usefulness of FFN and CL surveillance in predicting PTL and found 36 related papers. Although there is limited research available to show the impact of FFN and CL surveillance in the management of vasa previa, there is sufficient evidence to support FFN and CL surveillance in predicting the onset of PTL, which can have devastating consequences for the pregnancies affected. It can be extrapolated that these tools, by helping to determine pregnancies at risk for PTL, could improve management and outcomes in patients with vasa previa. Future studies investigating the management of vasa previa with FFN and CL surveillance to reduce the burden of PTL and its associated comorbidities are warranted. [ABSTRACT FROM AUTHOR]

Primary outcomes were to determine; 1) the desire for more patient information from healthcare professionals on preterm birth (PTB) prevention 2) the desire for PTB screening surveillance or participation in research or 3) the acceptability of transvaginal ultrasound (TVUS) or vaginal examinations to predict spontaneous PTB. A 19-question, piloted, self-administered survey was completed by unselected pregnant women in a tertiary maternity hospital in Dublin, Ireland. Data was collected to include maternal socio-demographics, past obstetric history, and current pregnancy details, in addition to views and preferences on PTB screening and preventative treatments. Statistical analysis to include binary and multinomial regression was performed by IBM SPSS Statistics for Windows (Version 29.0). 277 women completed the study survey. 9.4% of women had attended the preterm birth surveillance clinic (PSC). 75.1% of respondents indicated a preference for more information from healthcare professionals about PTB. 65% reported that TVUS and vaginal examinations were acceptable in pregnancy. The acceptability of antenatal examinations was significantly influenced by ethnicity; white European (OR 2.58, CI 1.12–5.95, p = 0.003) and Asian (OR 3.39, CI 1.18–9.67, p = 0.02). Discomfort (25.3%) and vaginal bleeding (11.9%) were the most frequently reported concerns about TVUS. 95.7% of unselected women indicated that they would accept treatment to prevent PTB. Vaginal progesterone (53.8%) was preferred treatment compared to cervical cerclage (15.9%) or cervical pessary (16.6%). 55.6% of respondents stated they attend or wish to attend for additional appointments or research opportunities for PTB screening. Women with a previous PTB or second trimester miscarriage were more likely to attend or wish to attend for PTB screening (OR 3.23, CI 1.34–7.79, p = 0.009). PTB is an important healthcare priority for pregnant women in Ireland. However, women require more information, counselling and reassurance about the utility and safety of TVUS in PSCs. [ABSTRACT FROM AUTHOR]

Abstract Background Spontaneous preterm birth (PTB) affects 6.5% of deliveries in Hong Kong. Quantitative fetal fibronectin (fFN) is under-utilised as a test for PTB prediction in Hong Kong. Our objective was to evaluate the effectiveness of quantitative fFN in predicting spontaneous PTB in women with symptoms of threatened preterm labour (TPTL) in our population. Methods A prospective, double-blinded cohort study of women with a singleton gestation and TPTL symptoms presenting to a tertiary hospital in Hong Kong between 24 + 0 to 33 + 6 weeks was performed from 1st October 2020 and 31st October 2021. Women with vaginal bleeding, ruptured membranes, and cervical dilation > 3 cm were excluded. The primary outcome was to test the characteristics of quantitative fFN in predicting spontaneous PTB 200 ng/ml as cut-off can also reliably predict delivery within 48 h – 7 days with positive predictive value PPV of 100%; as well as PTB before 37 weeks. Conclusions Quantitative fFN has predictive value for spontaneous PTB prediction in symptomatic women in a Hong Kong population. fFN concentration could help clinicians rule out PTB and avoid unnecessary interventions and hospitalisation.

Background: When the advantages of delivery for the mother or the foetus outweigh the hazards of continuing the pregnancy, labour should be induced. Objective: The purpose of the study was to examine the effectiveness of foetal fibronectin (fFN) and transvaginal cervix ultrasonography in predicting successful labour induction for unfavourable cervixes (Bishop score 5 or below). Subjects and Methods: In the Maternity Centre, Faculty of Medicine, Ain Shams University, a prospective study was carried out. Patients in this study were selected from those attending in Obstetrics Outpatient Department who were nullipara pregnant women. 40 women were assessed for study eligibility and fulfilled all inclusion criteria. Results: Mode of delivery had a significant correlation with Bishop score, while there was no discernible correlation between delivery method and transvaginal ultrasound. The bishop score was significantly correlated with fFN, all the cases with bishop 3 were negative fFN. The OSS showed insignificant relation with fFN. Also, there was no significant difference between negative and positive fFN regarding cervix (CX) length. The sensitivity of CX in prediction of successful labor induction occurring within 24 hours at cut off value of 3.11 was 50.0% and the specificity was 53.2%, and the accuracy was 51.1%. The Bishop score at cut off value of 4.0, the sensitivity was 60%, specificity was 64.5% and the accuracy was 62%. The sensitivity of fetal fibronectin in prediction of successful labor induction occurring within 24 hours at cutoff value 1.56 was 85%, the specificity was 80% and the accuracy was 82.6%. Conclusion: Although transvaginal cervical length measurement provides an objective way to evaluate the cervix when the Bishop score is equivocal, it may not be able to predict failed inductions with enough accuracy but it can help identify women who are at risk for caesarean delivery. fFN showed a highly significant sensitivity, specificity and accuracy to predict the successful induction of labor. [ABSTRACT FROM AUTHOR]

Background: Preterm labor and delivery remain a major problem in obstetrics accounting for perinatal morbidity and mortality. The challenge is to identify those with true preterm labor to avoid unnecessary hospital admissions. The fetal fibronectin (FFN) test is a strong predictor of preterm birth and can help identify women with true preterm labor. However, its cost-effectiveness as a strategy for triaging women with threatened preterm labor is still debatable. Objective: To evaluate the effect of FFN test implementation on hospital resources by reducing the admission rate of threatened preterm labor in a tertiary hospital, Latifa Hospital, UAE. Methods: A retrospective cohort study of singleton pregnancies between 24 and 34 weeks of gestation who attended Latifa Hospital in the period of September 2015–December 2016, complaining of threatened preterm labor after the availability of an FFN test, and a historical cohort study for those who attended with threatened preterm labor before the availability of an FFN test. Data analysis was performed using a Kruskal–Wallis test, Kaplan–Meier, Fischer exact chi-square and cost analysis. The significance was set at p-value < 0.05. Results: In total, 840 women met the inclusion criteria and were enrolled. The relative risk of FFN for delivery at term was 4.35 times higher among the negative-tested compared to preterm delivery (p-value < 0.001). A total of 134 (15.9%) women were unnecessarily admitted (FFN tested negative, delivered at term) which yielded $107,000 in extra costs. After the introduction of an FFN test, a 7% reduction of threatened preterm labor admissions was recorded. [ABSTRACT FROM AUTHOR]

Background: Spontaneous preterm birth (PTB) affects 6.5% of deliveries in Hong Kong. Quantitative fetal fibronectin (fFN) is under-utilised as a test for PTB prediction in Hong Kong. Our objective was to evaluate the effectiveness of quantitative fFN in predicting spontaneous PTB in women with symptoms of threatened preterm labour (TPTL) in our population. Methods: A prospective, double-blinded cohort study of women with a singleton gestation and TPTL symptoms presenting to a tertiary hospital in Hong Kong between 24 + 0 to 33 + 6 weeks was performed from 1st October 2020 and 31st October 2021. Women with vaginal bleeding, ruptured membranes, and cervical dilation > 3 cm were excluded. The primary outcome was to test the characteristics of quantitative fFN in predicting spontaneous PTB < 37 weeks. Secondary outcome was to investigate the relationship between fFN value and time to PTB. Test characteristics of quantitative fFN at different thresholds were evaluated. Results: 48 women with TPTL were recruited. All had fFN testing at admission with the results being concealed from the obstetrician managing the patient. 10 mothers had PTB (< 37 weeks' gestation). 7/48 (15%) had a subsequent PTB within 14 days from testing and 5 (10%) delivered within 48 h. The negative predictive value (NPV) of predicting delivery within 14 days was 97.3% and 100% when using a cut-off of < 50ng/ml and < 10ng/ml respectively. Using > 200 ng/ml as cut-off can also reliably predict delivery within 48 h – 7 days with positive predictive value PPV of 100%; as well as PTB before 37 weeks. Conclusions: Quantitative fFN has predictive value for spontaneous PTB prediction in symptomatic women in a Hong Kong population. fFN concentration could help clinicians rule out PTB and avoid unnecessary interventions and hospitalisation. [ABSTRACT FROM AUTHOR]

To develop a noninvasive scoring system to identify patients at high risk for intra-amniotic infection and/or inflammation, which would reduce the need for amniocentesis. This prospective cohort study comprised patients admitted with preterm labor and intact membranes (20–34 weeks of gestation) who underwent a transabdominal amniocentesis and for whom concentrations of quantitative cervical fetal fibronectin and of maternal serum C-reactive protein (CRP) were determined. Intra-amniotic infection was defined as a positive amniotic fluid culture for microorganisms. Intra-amniotic inflammation was defined as an amniotic fluid matrix metalloproteinase-8 concentration >23 ng/mL. Multivariate logistic regression analysis was performed to identify intra-amniotic infection/inflammtion with noninvasive parameters that had a significant relationship with univariate analysis. With four parameters identified by multivariate analysis, we generated a noninvasive risk scoring system. Of the study population consisting of 138 singleton pregnant women, (1) the overall rate of intra-amniotic infection/inflammation was 28.3% (39/138); (2) four parameters were used to develop a noninvasive risk scoring system [i.e. cervical fetal fibronectin concentration (score 0–2), maternal serum CRP concentration (score 0–2), cervical dilatation (score 0-2), and gestational age at presentation (score 0–1)]; the total score ranges from 0 to 7; 3) the area under the curve of the risk score was 0.96 (95% confidence interval (CI), 0.92–0.99), significantly higher than that of each predictor in the identification of intra-amniotic infection/inflammation (p <.001, for all); 4) the risk score with a cutoff of 4 had a sensitivity of 94.9% (37/39), a specificity of 90.9% (90/99), a positive predictive value of 80.4% (37/46), a negative predictive value of 97.8% (90/92), a positive likelihood ratio of 10.4 (95% CI, 5.6–19.5), and a negative likelihood ratio of 0.06 (95% CI, 0.15–0.22) in the identification of intra-amniotic infection/inflammation. (1) The combination of four parameters (concentrations of cervical fetal fibronectin and maternal serum CRP, cervical dilatation, and gestational age) was independently associated with intra-amniotic infection and/or inflammation; and (2) the risk scoring system comprised of the combination of 4 noninvasive parameters was sensitive and specific to identify the patients at risk for intra-amniotic infection and/or inflammation. [ABSTRACT FROM AUTHOR]

Objectives: The ability to predict spontaneous PTB (sPTB) has improved greatly, allowing women at risk to be managed with prophylactic interventions such as cervical cerclage and the Arabin pessary. Cervicovaginal fetal fibronectin (qfFN) concentration and ultrasound measurement of cervical length (CL) are the two most established tools to predict sPTB. There is however limited data regarding the predictive value of qfFN and CL tests following insertion of an Arabin pessary. Our aim was therefore to determine the clinical use of qfFN and CL measurements to predict sPTB in women fitted with an Arabin pessary.Study Design: This study is a secondary analysis on the SUPPORT trial data. Data were prospectively collected from women attending high-risk preterm surveillance clinics in 3 London centres between July 2015 and April 2020. The matched control group was pregnant women attending the same high-risk preterm surveillance clinics who had not received an Arabin pessary. Receiver operating characteristic (ROC) curves for prediction of birth by 34 and by 37 weeks' gestation were generated for qfFN and CL measurements combined for both study groups. A formal comparison of area under the curve before 34 weeks' gestation (AUC < 34 weeks) was made between the two study groups.Results: At our primary endpoint of sPTB < 34 weeks' gestation, qfFN was a good predictor of sPTB in cases with an Arabin pessary in situ (AUC, 0.79, 95% CI: 0.62-0.90) and no worse than the control group who did not have an Arabin pessary, (AUC 0.74, 95% CI: 0.48-0.96). CL had good prediction for sPTB < 34 weeks' gestation in the control group (AUC 0.76, 95% CI: 0.63-0.88) but was lower and non-significant in the Arabin pessary case group (AUC 0.60, 95% CI: 0.43-0.76).Conclusions: This study showed that cervicovaginal qfFN concentration is equally reliable in the prediction of sPTB in pregnant women at increased risk of sPTB with and without an Arabin pessary in situ, and significantly better than CL measurement alone for predicting delivery before 34 weeks. This commonly used test therefore has utility in predicting sPTB in pregnant women fitted with an Arabin pessary. [ABSTRACT FROM AUTHOR]

Preterm birth is associated with significant perinatal morbidity and mortality. Spontaneous preterm birth accounts for up to 75% of all preterm births. Several maternal and fetal characteristics have been associated with preterm birth. With a better understanding of the pathophysiology of preterm birth, various biochemical markers have been studied extensively to predict preterm birth efficiently to intervene appropriately and timely in the cases that would benefit from treatment. This paper provides a summary of the current literature on the use of biochemical markers in predicting spontaneous preterm birth in symptomatic and high-risk-asymptomatic women. For this review, we searched the Cochrane, Medline, PubMed databases and we have included studies from 2009 to date mentioning these important markers in predicting preterm labor. Evidence from the literature suggests cervicovaginal fetal fibronectin, interleukin-6, phosphorylated Insulin-like growth factor binding protein-1, placental alpha macroglobulin-1, and serumα-fetoprotein are promising biochemical markers in predicting spontaneous preterm birth. [ABSTRACT FROM AUTHOR]

Abstract Background To evaluate the self-reported pain scores as a predictor of preterm birth (PTB) in symptomatic twin pregnancy and to develop a nomogram for the prediction model. Methods We conducted a retrospective study of 148 cases of symptomatic twin pregnancies before 34 weeks of gestation visited at Seoul national university hospital from 2013 to 2018. With other clinical factors, self-reported pain score was evaluated by the numerical rating scale (NRS) pain scores for pain intensity. By multivariate analyses and logistic regression, we developed a prediction model for PTB within 7 days. Using the Cox proportional hazards model, the curves were plotted to show the predictability of the PTB according to NRS pain score, while adjusting the other covariates. Results Twenty-three patients (15.5 %) delivered preterm within 7 days. By a logistic regression analysis, higher NRS pain score (OR 1.558, 95 % CI 1.093–2.221, P

(1) Objective: This study aimed to determine whether qualitative fetal fibronectin and transvaginal sonographic measurement of cervical length are effective in predicting delivery in term pregnancies within 5 days of the test. (2) Methods: We examined 268 women with singleton pregnancies presenting themselves at 37+0–40+4 weeks (median 38 weeks + 1 day) of gestation with irregular and painful uterine contractions, intact membranes and cervical dilatation less than 2 cm. All women were admitted to hospital up to 72 h after birth. On admission, a qualitative fetal fibronectin test was performed in cervicovaginal secretions and transvaginal sonographic measurement of cervical length was carried out. The primary outcome measure was delivery within 5 days of presentation. RESULTS: Among the women who delivered within 5 days after admission, 65.2% had positive fFN assessment, 43.5% had cervical length below 26 mm, 52.2% had the age > 32.5 years, 34.8% were nulliparous and 56.5% had gestational age ≥ 275 days. Logistic regression analysis demonstrated that significant contributors to the prediction of delivery within 5 days were fibronectin positivity, cervical length ≤ 26 mm, maternal age > 32.5 years and gestational age ≥ 275 days, with no significant contribution from parity. (3) Conclusions: Qualitative fetal fibronectin test and transvaginal cervical length measurement in term pregnancies are useful tests for predicting spontaneous onset of labour within 5 days. It helps women and healthcare providers to determine the optimum time for hospital admission. [ABSTRACT FROM AUTHOR]

Purpose of the study is to improve the method of preterm deliveries onset predicting in pregnant women at 24–34 weeks. Materials and methods. 49 pregnant women with gestational age 24–34 weeks and with diagnosis of “threatening premature deliveries" were comprehensively examined using transvaginal ultrasound. Pregnant women with a shortened cervix ≤25 mm were given a qualitative determination of fetal fibronectin. The average age of pregnant women ranged from 26–34 years and averaged out 31.2 ± 0,6 years. Study results. Clinically significant structural changes in the cervix were only in 21 (42.9%) pregnant women. The average value of the cervix length varied between 16–24 mm and averaged 18.2 ± 0.4 mm. Positive test on fetal fibronectin in vaginal secretions was in 7 (33.3%) of 21 pregnant women with clinically significant structural changes in the cervix. During 10 days premature birth occurred in 3 (42.9%) of 7 pregnant women with clinically significant cervix shortening and a positive test for fetal fibronectin in the gestation period of 32 weeks. Hospitalization in an obstetric hospital was found to be unjustified in 28 (57.1%) cases. Conclusions. Combination of a comprehensive assessment of the cervix state and vaginal fetal fibronectin evaluation in pregnant women with risk of preterm deliveries at the outpatient stage allows to predict the manifestation of preterm birth in critical terms also determine the volume and direction of therapy in obstetric department. Combination of this methods help to prevent unwarranted hospitalization of a pregnant woman in an obstetric hospital and as a result it limits the conduct of glucocorticoid therapy and prevent a prolong stay of a pregnant woman in a hospital and the associated contamination with nosocomial bacteria strains.

E-Cervix™ (WS80A; Samsung, Seoul, Korea) elastography is a recent quantification tool to measure the stiffness of the cervix using strain elastography. The aim of this study was to evaluate the prediction performance of E-cervix for preterm birth in singleton gestation with threatened preterm labor (PTL). This was a cohort study of singleton pregnancies without prior preterm birth presenting to obstetrics triage for threatened PTL between 23 0/7 and 33 6/7 week who received screening for PTL with transvaginal ultrasound cervical length (TVU CL) and cervical elastography with E-cervix at the time of triage. Cervical elastography parameters were examined and compared between women who delivered preterm and those who did not. The quantification of cervical strain was calculated by a data analysis system that directly analyses raw data from the region of interest (ROI) and described as hardness ratio (HR), mean strain level within 1 cm from internal os (IOS) and external os (EOS). Ninety-five singleton pregnancies without prior preterm birth and with threatened PTL between 23 0/7 and 33 6/7 week of gestation were included in the study. Forty-two (44.2%) had cervical length <25 mm, and were admitted for true PLT. Out of the 53 women with cervical length ≥25 mm, 40 (75.5%) were discharged, and 13 (24.5%) were admitted. Women with threatened PTL but without true PTL, had significantly higher HR compared to those with true PTL (49.0 ± 20.9% versus 34.8 ± 19.6%; p <.01), and significantly lower stiffness of cervical IOS and EOS. Women who delivered preterm had significantly lower HR compared to those who did not delivery preterm, in overall cohort, and in the subset of only women with true PTL. Incidences of HR < 50% and <35% were statistically significantly higher in women who delivered preterm compared to those who did not (p <.01). Cervical elastography with E-cervix may be useful for the assessment of women presenting to obstetrics triage for threatened PTL. Women with low HR, especially with HR less than 50 or 35%, are at increased risk of PTB. Women who delivered preterm had significantly lower HR compared to those who did not delivery preterm and significantly lower IOS and EOS, in overall cohort, and in the subset of women with true PTL. Incidences of HR < 50% and <35% were statistically significantly higher in women who delivered preterm compared to those who did not (p <.01). Cervical elastography with E-cervix may be useful for the assessment of women presenting to obstetrics triage for threatened PTL. [ABSTRACT FROM AUTHOR]

Background: Many women living in rural and remote Australia are required to travel large distances to birth in a hospital with maternity facilities, incurring considerable financial, social and emotional burden for them and their families. No studies to date have investigated the use of quantitative fetal fibronectin (qfFN) to predict term labour in asymptomatic pregnant women. A tool which is able to more accurately predict term labour has the potential to guide informed travel decision‐making for women and healthcare professionals in rural and remote Australia. Aim: The aim of this study is to determine if qfFN can reliably predict term labour in asymptomatic women from rural and remote areas. Materials and Methods: Thirty‐nine women from rural Australia provided 71 fFN samples between June 2016 and October 2018, from 37 weeks' gestation, with at least one week between samples for those providing multiple samples. Days from fFN sampling until spontaneous onset of labour were recorded. Using generalised estimating equation modelling we examined the utility of fFN as a predictor for onset of labour at term after adjusting for confounders. Results: There was a small‐to‐moderate negative correlation (rs −0.27, P < 0.05) between time until labour and fFN. Quantitative fFN was observed to be a significant predictor of time until labour after adjusting for confounding variables (P < 0.001). Conclusion: fFN levels may play a role in predicting term labour in rural women; however, future studies with a larger sample size are required to validate the findings of our pilot study. [ABSTRACT FROM AUTHOR]

Background: The diagnosis of preterm labour is challenging. False-positive diagnoses are common and result in unnecessary, potentially harmful treatments (e.g. tocolytics, antenatal corticosteroids and magnesium sulphate) and costly hospital admissions. Measurement of fetal fibronectin in vaginal fluid is a biochemical test that can indicate impending preterm birth. Objectives: To develop an externally validated prognostic model using quantitative fetal fibronectin concentration, in combination with clinical risk factors, for the prediction of spontaneous preterm birth and to assess its cost-effectiveness. Design: The study comprised (1) a qualitative study to establish the decisional needs of pregnant women and their caregivers, (2) an individual participant data meta-analysis of existing studies to develop a prognostic model for spontaneous preterm birth within 7 days in women with symptoms of preterm labour based on quantitative fetal fibronectin and clinical risk factors, (3) external validation of the prognostic model in a prospective cohort study across 26 UK centres, (4) a model-based economic evaluation comparing the prognostic model with qualitative fetal fibronectin, and quantitative fetal fibronectin with cervical length measurement, in terms of cost per QALY gained and (5) a qualitative assessment of the acceptability of quantitative fetal fibronectin. Data sources/setting: The model was developed using data from five European prospective cohort studies of quantitative fetal fibronectin. The UK prospective cohort study was carried out across 26 UK centres. Participants: Pregnant women at 22+0–34+6 weeks’ gestation with signs and symptoms of preterm labour. Health technology being assessed: Quantitative fetal fibronectin. Main outcome measures: Spontaneous preterm birth within 7 days. Results: The individual participant data meta-analysis included 1783 women and 139 events of spontaneous preterm birth within 7 days (event rate 7.8%). The prognostic model that was developed included quantitative fetal fibronectin, smoking, ethnicity, nulliparity and multiple pregnancy. The model was externally validated in a cohort of 2837 women, with 83 events of spontaneous preterm birth within 7 days (event rate 2.93%), an area under the curve of 0.89 (95% confidence interval 0.84 to 0.93), a calibration slope of 1.22 and a Nagelkerke R2 of 0.34. The economic analysis found that the prognostic model was cost-effective compared with using qualitative fetal fibronectin at a threshold for hospital admission and treatment of ≥ 2% risk of preterm birth within 7 days. Limitations: The outcome proportion (spontaneous preterm birth within 7 days of test) was 2.9% in the validation study. This is in line with other studies, but having slightly fewer than 100 events is a limitation in model validation. Conclusions: A prognostic model that included quantitative fetal fibronectin and clinical risk factors showed excellent performance in the prediction of spontaneous preterm birth within 7 days of test, was cost-effective and can be used to inform a decision support tool to help guide management decisions for women with threatened preterm labour. Future work: The prognostic model will be embedded in electronic maternity records and a mobile telephone application, enabling ongoing data collection for further refinement and validation of the model. Study registration: This study is registered as PROSPERO CRD42015027590 and Current Controlled Trials ISRCTN41598423. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 52. See the NIHR Journals Library website for further project information.

Objectives: Preterm birth (PTB) accounts for two-thirds of deaths of structurally normal babies and is associated with substantial lifetime healthcare costs. Prevention of PTB remains limited by the modest accuracy of prediction methods, namely transvaginal ultrasound (TVS) cervical length (CL) measurement and quantitative cervicovaginal fetal fibronectin (FFN) estimation. We report the first substantive study detailing the predictive performance of a cervical probe device based on electrical impedance spectroscopy (EIS) for PTB - the EleCtriCaL Impedance Prediction of Preterm birth by spectroscopy of the cervix (ECCLIPPx) study. We aimed to compare the accuracy of cervical EIS-based prediction of spontaneous PTB with that of prediction using TVS-CL and FFN in asymptomatic women in the mid-trimester.Methods: We studied asymptomatic women with a singleton pregnancy at 20-22 weeks' and 26-28 weeks' gestation. EIS was performed using a Sheffield Mark 5.0 device that makes measurements in the frequency range 76 Hz to 625 kHz using a small probe housing tetrapolar electrodes. TVS-CL and FFN were also measured. The associations of cervical EIS, TVS-CL and FFN with spontaneous delivery before 37 weeks and before 32 weeks were determined by multivariate linear and non-linear logistic regression analysis. Areas under the receiver-operating-characteristics curves (AUC) plots of sensitivity against specificity were used to compare the predictive performance of all parameters, both in isolation and in combination.Results: Of the 365 asymptomatic women studied at 20-22 weeks who were not receiving treatment, 29 had spontaneous PTB, 14 had indicated PTB and 322 had term birth. At the higher frequencies assessed, cervical EIS predicted spontaneous PTB before 37 weeks with an AUC of 0.76 (95% CI, 0.71-0.81), compared with AUCs of 0.72 (95% CI, 0.66-0.76) for TVS-CL and 0.62 (95% CI, 0.56-0.72) for FFN. Combining all three assessments improved the prediction of spontaneous PTB before 37 weeks (AUC, 0.79 (95% CI, 0.74-0.83)) compared with TVS-CL and FFN alone. Incorporating a history of spontaneous PTB (defined as previous mid-trimester miscarriage or spontaneous PTB (14 to < 37 weeks)) into the cervical EIS prediction model improved the accuracy of prediction of spontaneous PTB before 37 weeks (AUC, 0.83 (95% CI, 0.78-0.87)) and before 32 weeks (AUC, 0.86 (95% CI, 0.82-0.90)).Conclusions: Mid-trimester cervical EIS assessment predicts spontaneous PTB. Larger confirmatory studies investigating its potential clinical utility and to inform effective preventive interventions are required. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Abstract Background Accurate diagnosis of preterm labour is needed to ensure correct management of those most at risk of preterm birth and to prevent the maternal and fetal risks incurred by unnecessary interventions given to the large majority of women, who do not deliver within a week of presentation. Intervention “just-in-case” results in many avoidable admissions, women being transferred out of their local hospital unnecessarily and most women receiving unwarranted drugs, such as steroids and tocolytics. It also precludes appropriate transfers for others as neonatal cots are blocked pre-emptively, resulting in more dangerous ex-utero transfers. We have developed the QUiPP App which is a clinical decision-making aid based on previous outcomes of women, quantitative fetal fibronectin (qfFN) values and cervical length. It is hypothesised that using the QUiPP app will reduce inappropriate admissions and transfers. Methods A multi-site cluster randomised trial will evaluate whether the QUiPP app reduces inappropriate management for threatened preterm labour. The 13 participating centres will be randomly allocated to receive either intervention or control. If the QUiPP app calculates risk of delivery within 7 days to be is less than 5%, clinicians are advised that interventions may be withheld. Women’s experience of threatened preterm labour assessment will be explored using self-completed questionnaires, with a subset of participants being invited to semi-structured interview. A health economics analysis is also planned. Discussion We hypothesise that the QUiPP app will improve identification of the most appropriate women for admission and transfer and ensure that therapies known to reduce risk of preterm neonatal morbidities are offered to those who need them. We will determine which women do not require these therapies, thereby reducing over-medicalisation and the associated maternal and fetal risks for these women. The findings will inform future national guidelines on threatened preterm labour. Beyond obstetrics, evaluating the impact of an app in an emergency setting, and our emphasis on balancing harms of over-treatment as well as under-treatment, make EQUIPTT a valuable contribution to translational medicine. Trial registration The EQUIPTT trial was prospectively registered on 16th January 2018 with the ISRCTN registry (no. 17846337).

Background: To evaluate the self-reported pain scores as a predictor of preterm birth (PTB) in symptomatic twin pregnancy and to develop a nomogram for the prediction model.Methods: We conducted a retrospective study of 148 cases of symptomatic twin pregnancies before 34 weeks of gestation visited at Seoul national university hospital from 2013 to 2018. With other clinical factors, self-reported pain score was evaluated by the numerical rating scale (NRS) pain scores for pain intensity. By multivariate analyses and logistic regression, we developed a prediction model for PTB within 7 days. Using the Cox proportional hazards model, the curves were plotted to show the predictability of the PTB according to NRS pain score, while adjusting the other covariates.Results: Twenty-three patients (15.5 %) delivered preterm within 7 days. By a logistic regression analysis, higher NRS pain score (OR 1.558, 95 % CI 1.093-2.221, P < 0.05), shorter cervical length (OR 3.164, 95 % CI 1.262-7.936, P < 0.05) and positive fibronectin results (OR 8.799, 95 % CI 1.101-70.330, P < 0.05) affect PTB within 7 days. Using the variables, the area under the receiver operating characteristic curve (AUROC) of the prediction model was 0.917. In addition, we developed a nomogram for the prediction of PTB within 7 days.Conclusions: Self-reported pain scores combined with cervical length and fetal fibronectin are useful in predicting impending PTB in symptomatic twin pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate cervicovaginal fluid quantitative fetal fibronectin, measured by a bedside analyzer, to predict spontaneous preterm birth in twin pregnancy before 30 weeks of gestation.Material and Methods: In a prospective cohort study, we studied the accuracy of quantitative fetal fibronectin measured between 18 and 27+6 weeks of gestation in high-risk asymptomatic women with twin pregnancies, to predict spontaneous preterm birth before 30 weeks of gestation. Predefined fetal fibronectin thresholds were ≥10, ≥50 and ≥200 ng/mL. Predictive statistics were also calculated to evaluate accuracy of "early" tests, performed between 18 and 21+6 weeks and "standard" tests performed between 22+0 and 27+6 weeks of gestation in the same cohort. Subgroup analysis was performed according to cervical length measurement. In addition, we compared accuracy of prediction with quantitative fetal fibronectin measured during the standard test period in asymptomatic twin pregnancy with no additional risk factors, to twin pregnancies with one or more additional risk factors for spontaneous preterm birth.Results: Of 130 eligible women identified with quantitative fetal fibronectin tests undertaken during the standard testing period, 9% delivered before 30 weeks of gestation. Quantitative fetal fibronectin was significantly related to outcome before 30/40 (ROC curves of 0.8 [95% CI 0.7-1]). Early tests were not significantly predictive; ROC area 0.53 (95% CI 0.29-0.81). There was a trend towards better predictive accuracy when one or more additional risk factors for spontaneous preterm birth or cervical length were considered.Conclusions: Quantitative fetal fibronectin measured from 22 to 27+6 weeks of gestation accurately predicts spontaneous preterm birth at <30 weeks of gestation. Tests undertaken earlier are of limited value. Consideration of cervical length or prior history in addition to quantitative fetal fibronectin strengthens prediction. [ABSTRACT FROM AUTHOR]

Objective: To examine the utility of fetal fibronectin (fFN) for predicting spontaneous preterm birth (PTB) in asymptomatic women with a cervical length (CL) ≤10 mm compared to those with a CL 11-25 mm.Methods: Data was collected on all women with nonanomalous singleton and twin gestations who underwent transvaginal CL at a single institution between 2009 and 2012. Women with an incidental short cervix (CL ≤ 25 mm) between 22 and 32 weeks who had an fFN result within 7 days thereafter were included. Indicated preterm deliveries at <14 days of fFN, women who underwent cerclage placement, and terminations of pregnancy were excluded. The primary outcome was spontaneous PTB within 7 and 14 days of the fFN. Sensitivity, specificity, and positive (PPV) and negative predictive value (NPV) of fFN for a CL ≤ 10 mm was calculated for singletons and twins and compared to those with a CL 11-25 mm.Results: Of the 213 women included, 117 (54.9%) were singletons and 96 (45%) were twins. Baseline characteristics were similar between those with a CL ≤ 10 mm and with a CL 11-25 mm in both singletons and twins. The NPV of fFN for delivery within 7 days in singletons and twins with a CL ≤ 10 mm was 100%, similar to those with a CL 11-25 mm (93-100%). The NPV of fFN for delivery within 14 days in singletons and twins with a CL ≤ 10 mm remained high (87.5-100%) when compared to those with a CL 11-25 mm (93-100%). The PPV of fFN for delivery within 7 and 14 days in both singletons and twins with a CL ≤ 10 mm was low (10-25%) and similar to those with a CL 11-25 mm (7.1-24.4%).Conclusions: The NPV of fFN in asymptomatic singleton and twin pregnancies with a CL ≤ 10 mm is high and comparable to the NPV of fFN in women with a longer CL. Routine fFN collection in this select population should be considered as it may avoid unnecessary and costly admissions, as well as assist with timing of antenatal corticosteroids. [ABSTRACT FROM AUTHOR]

Cervical cancer is increasingly diagnosed in women who have not yet completed their reproductive plans. For women with early-stage disease (FIGO stage IA1-IB1), fertility-sparing procedures, such as conization, trachelectomy or radical trachelectomy, represent the treatments of choice. However, women who undergo repeated conization or trachelectomy represent a challenge for obstetricians because they are at increased risk of infertility, mid-trimester miscarriage, preterm premature rupture of membranes and preterm delivery. So far, the evidence-based guidance on the management of these pregnancies is limited. This article reviews the literature discussing pregnancy management in women after fertility-sparing surgery for early cervical cancer. Although the evidence is limited, certain measures are desirable, including screening and treatment of asymptomatic bacteriuria, screening for cervical incompetence and progressive cervical shortening by transvaginal ultrasonography, and fetal fibronectin testing. Vaginal progesterone supplementation should be primary prevention for all women after trachelectomy. Women with a history of preterm delivery or late miscarriage may benefit from cervical cerclage. Elective delivery by cesarean section in the early-term period is desirable. [ABSTRACT FROM AUTHOR]

Objectives: To compare accuracy between Premaquick (combined test for native insulin-like growth factor binding protein-1 (IGFBP-1), total IGFBP-1, and interleukin-6) and fetal fibronectin (Ffn) in predicting preterm delivery.Methods: Prospective study among women at 28-36+6 gestational weeks with threatened preterm labor attending Federal Medical Center, Owerri, Nigeria, from August 2017 to February 2019. Cervico-vaginal fluids were collected and tested by Premaquick and Ffn tests. The women were followed for 14 days. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive value for delivery were compared between the tests.Results: Among 213 women assessed for eligibility, 183 were enrolled and 175 completed the study. The sensitivity, specificity, PPV, NPV, and accuracy of the Premaquick versus Ffn tests were, respectively, 96.3% versus 51.9%, 97.6% versus 98.4%, 89.7% versus 87.5%, 99.2% versus 90.3% and 97.3% versus 90.0% for preterm delivery within 14 days. Ffn had higher specificity (98.5% vs 97.8%; P>0.99), but Premaquick had higher PPV (92.7% vs 90.9%; P>0.99).Conclusion: Both tests seem to have high utility in predicting preterm delivery, but Premaquick showed higher accuracy in terms of sensitivity and PPV. Premaquick might be a feasible alternative to Ffn for predicting preterm delivery among symptomatic women in a low-income setting. [ABSTRACT FROM AUTHOR]

Objectives: Twin pregnancies have a higher likelihood to experience spontaneous preterm birth (PTB). Those with imminent PTB need to be determined in order to undergo fetal lung maturation with glucocorticoids and therewith improve neonatal outcomes. The aim of this study was to assess the predictive value of the fetal fibronectin (fFN) test and the measurement of cervical length in twin pregnancies with symptoms of imminent PTB.Study Design: We performed an observational study on all twin pregnancies at the Medical University Vienna. Women were admitted to the hospital either due to symptoms of imminent PTB or due to a shortening of the cervical length before completed 34 weeks of gestational age. Logistic regression analysis was performed to assess the predictive value of the fFN test and cervical length on imminent preterm birth.Results: The data of 82 women with twin pregnancies were eligible, of which 10 (12 %) had a positive, 45 (55 %) a negative, 21 (26 %) an unclear fFN result, and 6 (7 %) showed missing data. Cervical length ≤20 mm did not show any statistical significant prediction of PTB in our study cohort. After 7 days, 4/10 (40 %) pregnant women with positive fFN test gave birth, while 4/45 (9 %) women with a negative fFN test gave birth. Within 14 days after hospitalization, 6/10 (60 %) women with a positive fFN test gave birth, compared to 4/45 (9 %) with a negative fFN test. The positive fFN test was a statistically significant predictor of PTB within 7 days (p = 0.02) and 14 days (p = 0.004), respectively.Conclusion: The fFN test has the potential to detect women with twin pregnancies, who are at risk of giving birth within the following days. Hence, the practice of hospitalizing women solely due to the shortening of the cervical length cannot be supported. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the clinical management to withhold treatment for preterm labor in symptomatic women with an intermediate cervical length and negative fetal fibronectin (fFN) testing. Methods: A retrospective cohort study was performed in a tertiary care teaching hospital in the Netherlands. Pregnant women with a gestational age between 23+5 to 34+0 weeks, with the presence of regular uterine contractions accompanied by a cervical length between 15 and 30 mm and intact membranes, who underwent fFN testing were included to obtain the diagnostic value of fFN testing for preterm delivery within 7 days. Results: Fetal fibronectin testing has an extremely high negative predictive value (100%) and sensitivity (100%) for delivery within 7 days, in singleton and multiple pregnancies. However, specificity (64%) and positive predictive value (10%) of fFN testing in singleton pregnancies are low. Blood present on the fFN sample does not affect the reliability of the fFN test; the negative predictive value remains 100%. Conclusion: Women with symptoms of early preterm labor, intact membranes, a cervical length between 15 and 30 mm and negative fFN testing do not deliver within 7 days. Administration of corticosteroids and tocolytics can safely be withhold. Furthermore, blood on the fFN sample does not change the reliability of the fFN test. [ABSTRACT FROM AUTHOR]

Objectives: Accurate mid-pregnancy prediction of spontaneous preterm birth (sPTB) is essential to ensure appropriate surveillance of high-risk women. Advancing the QUiPP App prototype, QUiPP App v.2 aimed to provide individualized risk of delivery based on cervical length (CL), quantitative fetal fibronectin (qfFN) or both tests combined, taking into account further risk factors, such as multiple pregnancy. Here we report development of the QUiPP App v.2 predictive models for use in asymptomatic high-risk women, and validation using a distinct dataset in order to confirm the accuracy and transportability of the QUiPP App, overall and within specific clinically relevant time frames.Methods: This was a prospective secondary analysis of data of asymptomatic women at high risk of sPTB recruited in 13 UK preterm birth clinics. Women were offered longitudinal qfFN testing every 2-4 weeks and/or transvaginal ultrasound CL measurement between 18 + 0 and 36 + 6 weeks' gestation. A total of 1803 women (3878 visits) were included in the training set and 904 women (1400 visits) in the validation set. Prediction models were created based on the training set for use in three groups: patients with risk factors for sPTB and CL measurement alone, with risk factors for sPTB and qfFN measurement alone, and those with risk factors for sPTB and both CL and qfFN measurements. Survival analysis was used to identify the significant predictors of sPTB, and parametric structures for survival models were compared and the best selected. The estimated overall probability of delivery before six clinically important time points (< 30, < 34 and < 37 weeks' gestation and within 1, 2 and 4 weeks after testing) was calculated for each woman and analyzed as a predictive test for the actual occurrence of each event. This allowed receiver-operating-characteristics curves to be plotted, and areas under the curve (AUC) to be calculated. Calibration was performed to measure the agreement between expected and observed outcomes.Results: All three algorithms demonstrated high accuracy for the prediction of sPTB at < 30, < 34 and < 37 weeks' gestation and within 1, 2 and 4 weeks of testing, with AUCs between 0.75 and 0.90 for the use of qfFN and CL combined, between 0.68 and 0.90 for qfFN alone, and between 0.71 and 0.87 for CL alone. The differences between the three algorithms were not statistically significant. Calibration confirmed no significant differences between expected and observed rates of sPTB within 4 weeks and a slight overestimation of risk with the use of CL measurement between 22 + 0 and 25 + 6 weeks' gestation.Conclusions: The QUiPP App v.2 is a highly accurate prediction tool for sPTB that is based on a unique combination of biomarkers, symptoms and statistical algorithms. It can be used reliably in the context of communicating to patients the risk of sPTB. Whilst further work is required to determine its role in identifying women requiring prophylactic interventions, it is a reliable and convenient screening tool for planning follow-up or hospitalization for high-risk women. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Introduction: This study aims to compare the use of qualitative fetal fibronectin, quantitative fetal fibronectin, and placental α-microglobulin-1 in women with symptoms of preterm labor, to evaluate which vaginal biomarker performs the best in clinical practice.Material and Methods: This prospective observational study included women who presented with symptoms of preterm labor at 24+0 to 34+0  weeks of gestation at a large tertiary maternity hospital in Auckland, New Zealand. Women were managed according to hospital guidelines using qualitative fetal fibronectin. Quantitative fetal fibronectin and placental α-microglobulin-1 tests were also taken, with clinicians blinded to the results. Management and delivery outcomes were collected from clinical records. The primary outcome was the rate of antenatal hospital admission. Analysis was performed according to predefined management protocols for each of the tests.Results: A total of 128 women had all three biomarkers tests taken. Spontaneous preterm birth rates were 7/128 (5.5%) ≤34+0  weeks and 20/128 (15.6%) <37+0  weeks of gestation; 5/128 (3.9%) delivered within 7 days of testing. Positive results were recorded in 28 qualitative fetal fibronectin tests, 25 quantitative fetal fibronectin tests with 11 ≥200 ng/mL, and 16 placental α-microglobulin-1 tests. The use of quantitative fetal fibronectin or placental α-microglobulin-1 would have lowered antenatal admission rates: 27/128 (21.1%) for qualitative fetal fibronectin, 11/128 (8.6%) for quantitative fetal fibronectin (admission threshold ≥200 ng/mL), and 15/128 (11.7%) for placental α-microglobulin-1. No additional women with quantitative fetal fibronectin <200 ng/mL delivered within 7 days or missed corticosteroids compared with standard care (qualitative fetal fibronectin); however, an additional 3 cases had a false-negative placental α-microglobulin-1 and clinical care may have been compromised (no antenatal corticosteroids or admission).Conclusions: The use of quantitative fetal fibronectin (admission threshold ≥200 ng/mL) has the potential to reduce the rate of antenatal admissions for women with symptoms of preterm labor without compromising use of antenatal interventions that improve outcomes for babies born preterm. [ABSTRACT FROM AUTHOR]

Context: Preterm birth accounts for significant neonatal mortality and morbidity as well as substantial health costs. As our understanding of aetiology and risk factors for preterm birth increases, predictive tools and prophylactic interventions have been developed to improve maternal and fetal outcomes. These are effective, but require surveillance of asymptomatic high-risk women, as well as ultrasound and surgical expertise. This has led to the development of preterm birth surveillance clinics (PSCs), which pool these resources together and have changed the focus of care from reactive to predictive and preventative management. Methods: A literature review of the evidence surrounding the predictive tests (cervical length, fetal fibronectin, Actim Partus, Partosure) and prophylactic interventions (cerclage, progesterone, Arabin pessary, antibiotics, and steroids) for preterm birth to understand what preterm birth surveillance clinics do and how effective they are. Results: Measuring cervical length and fetal fibronectin levels are two of the most accurate predictive tests preterm birth, especially when used in combination. Other predictive tools like Actim Partus and Partosure are effective for symptomatic women, but their role in surveillance of asymptomatic women is unclear. Cervical cerclage is effective in reducing preterm birth in women with previous losses, but the role of progesterone and pessaries remains debated. Steroids remain one of the most effective antenatal intervention, but they need to be administered within a tight timeframe in order to confer maximal benefit. The role of PSCs in predicting the timing of birth and targeting women at highest risk to appropriate interventions is therefore crucial in optimizing care and improving outcomes. Conclusions: Nearly every step of management is still debated although many have a strong evidence-base and effective interventions do exist. The challenge is finding the optimal management pathway, and details of which populations benefit from which interventions need to be evaluated. While evidence continues to be collated, the poor outcomes of preterm birth and the multiple options available to reduce them justify preterm birth surveillance clinics being resourced.

Background: Preterm birth may result in short- and long-term health problems for the child. Accurate diagnoses of preterm births could prevent unnecessary (or ensure appropriate) admissions into hospitals or transfers to specialist units. Objectives: The purpose of this report is to assess the test accuracy, clinical effectiveness and cost-effectiveness of the diagnostic tests PartoSure™ (Parsagen Diagnostics Inc., Boston, MA, USA), Actim® Partus (Medix Biochemica, Espoo, Finland) and the Rapid Fetal Fibronectin (fFN)® 10Q Cassette Kit (Hologic, Inc., Marlborough, MA, USA) at thresholds ≠50 ng/ml [quantitative fFN (qfFN)] for women presenting with signs and symptoms of preterm labour relative to fFN at 50 ng/ml. Methods: Systematic reviews of the published literature were conducted for diagnostic test accuracy (DTA) studies of PartoSure, Actim Partus and qfFN for predicting preterm birth, the clinical effectiveness following treatment decisions informed by test results and economic evaluations of the tests. A model-based economic evaluation was also conducted to extrapolate long-term outcomes from the results of the diagnostic tests. The model followed the structure of the model that informed the 2015 National Institute for Health and Care Excellence guidelines on preterm labour diagnosis and treatment, but with antenatal steroids use, as opposed to tocolysis, driving health outcomes. Results: Twenty studies were identified evaluating DTA against the reference standard of delivery within 7 days and seven studies were identified evaluating DTA against the reference standard of delivery within 48 hours. Two studies assessed two of the index tests within the same population. One study demonstrated that depending on the threshold used, qfFN was more or less accurate than Actim Partus, whereas the other indicated little difference between PartoSure and Actim Partus. No study assessing qfFN and PartoSure in the same population was identified. The test accuracy results from the other included studies revealed a high level of uncertainty, primarily attributable to substantial methodological, clinical and statistical heterogeneity between studies. No study compared all three tests simultaneously. No clinical effectiveness studies evaluating any of the three biomarker tests were identified. One partial economic evaluation was identified for predicting preterm birth. It assessed the number needed to treat to prevent a respiratory distress syndrome case with a ‘treat-all’ strategy, relative to testing with qualitative fFN. Because of the lack of data, our de novo model involved the assumption that management of pregnant women fully adhered to the results of the tests. In the base-case analysis for a woman at 30 weeks’ gestation, Actim Partus had lower health-care costs and fewer quality-adjusted life-years (QALYs) than qfFN at 50 ng/ml, reducing costs at a rate of £56,030 per QALY lost compared with qfFN at 50 ng/ml. PartoSure is less costly than Actim Partus while being equally effective, but this is based on diagnostic accuracy data from a small study. Treatment with qfFN at 200 ng/ml and 500 ng/ml resulted in lower cost savings per QALY lost relative to fFN at 50 ng/ml than treatment with Actim Partus. In contrast, qfFN at 10 ng/ml increased QALYs, by 0.002, and had a cost per QALY gained of £140,267 relative to fFN at 50 ng/ml. Similar qualitative results were obtained for women presenting at different gestational ages. Conclusion: There is a high degree of uncertainty surrounding the test accuracy and cost-effectiveness results. We are aware of four ongoing UK trials, two of which plan to enrol > 1000 participants. The results of these trials may significantly alter the findings presented here. Study registration: The study is registered as PROSPERO CRD42017072696. Funding: The National Institute for Health Research Health Technology Assessment programme.

Objective: The objective of this study is to compare the qualitative fFN test at 50 ng/ml threshold to novel methods for assessing risk of imminent sPTB in women with symptoms of preterm labor (PTL): (1) quantitative fetal fibronectin (qfFN) at four thresholds: 10, 50, 200, and 500 ng/ml; and (2) qualitative PAMG-1 test. Study design: Consecutive patients presenting with singleton pregnancies, signs of PTL, gestational age 23.1-34.6, intact membranes, no coitus within 24 h, and cervical dilation ≤3 cm. fFN was performed as standard of care, while clinicians were blinded to the qfFN and PAMG-1 test results. qfFN accuracy was evaluated at four thresholds of 10, 50, 200, and 500 ng/ml for its ability to predict imminent spontaneous preterm delivery (sPTD) ≤ 7 and ≤14 d from the time of sample collection. The PAMG-1 test was evaluated based on its qualitative result for the same delivery endpoints. Results: Seventy-two patients were analyzed. Fifty-seven percent of patients had an fFN concentration of <10 ng/ml fFN; 75% < 50 ng/ml; 92% < 200 ng/ml; 97% < 500 ng/ml. The SN, SP, PPV, and NPV for fFN at each of the four cutoffs for sPTB ≤7 d: 10 ng/ml: 67%, 58%, 6%, 98%; 50 ng/ml: 67%, 77%, 11%, 98%; 200 ng/ml: 33%, 93%, 17%, 97%; 500 ng/ml: 0%, 97%, 0%, 96%. The PAMG-1 test was positive in 7% of patients. SN, SP, PPV, and NPV for PAMG-1 for sPTD ≤7 d were 67%, 96%, 40%, and 99%, respectively. Conclusion: Compared with qfFN, the PAMG-1 test is a better predictor of spontaneous delivery within 7 d while maintaining a very high negative predictive value. The PAMG-1 test is an easy-to-use bedside test that provides rapid results, does not require a speculum examination, can be used after vaginal exam and coitus and does not require specialized equipment to analyze results. As to be expected, compared with the conventional cutoff of fFN (50 ng/ml), a higher fFN cutoff of 200 ng/ml does seem to increase the PPV of the test, but this comes at a cost to the fFN test's SN and NPV, rendering it of little to no advantage in clinical practice. [ABSTRACT FROM AUTHOR]

Objective To establish a quantitative immunochromatography assay for the rapid detection of fetal fibronectin (fFN), which based on the utilize of time resolved fluorescent micro spheres, and the method properties were evaluated. Methods The fFN diagnose strip was manufactured by applying the double antibody sandwich method and fluorescent immunochromatography assay. The limit of blank and precision of the strip associated with stability and consistency with compared assay kit were evaluated. Results The results showed that the limit of blank was 4 ng/mL. The precision of intra-assay and inter assay CV were less than 10% and 15%, respectively. After keeping the strips at 37 °C for 14 days, the performance of the strip did not decline markedly. The correlation between the research and fFN detection kit of Re Jing company was good (r² = 0. 973 0). Conclusion The d veloped fluorescent immunochromatography assay strip for quantitative detection of fFN has advantages of sensitive, accurate, rapid and simple operation, can meet the needs of the clinical diagnose of fFN. [ABSTRACT FROM AUTHOR]

Background: Recent data suggest that quantitative measurements of fetal fibronectin can be used accurately to predict increased risk of preterm birth. Aim: The purpose of this study was to demonstrate that the quantification of fetal fibronectin improves diagnostic accuracy in women who present with symptoms suggestive of threatened preterm labour (TPL) using a quantitative fetal fibronectin (qfFN) bedside analyser. Study design: This was a retrospective cohort study of pregnant women who presented between 22+6 and 32+6 weeks gestation with symptoms of TPL who had qfFN measured using the Rapid fFN Q10 system. The ability to predict spontaneous preterm birth (sPTB) within 48 h, 14 days and <34 weeks gestation at qfFN thresholds of 10, 50 and 200 ng/mL was assessed. Results: The overall rate of sPTB <34 weeks was 4.1% (n = 373). For deliveries within 48 h, within 14 days and <34 weeks, a qfFN threshold of 200 ng/mL had positive predictive values of 26.7%, 42.9% and 46.7%, respectively, when compared to patients with qfFN values of 0–9 ng/mL. The corresponding relative risks were 68.5, 53.8 and 38.0, respectively Conclusion: Quantitative fetal fibronectin testing with thresholds of 10, 50 and 200 ng/mL allows for more accurate prediction of preterm birth in symptomatic women. This higher degree of discrimination allows for more directed interventions for high‐risk patients and reduces the cost and burden of unnecessary treatment for low‐risk patients. [ABSTRACT FROM AUTHOR]

Background: Preterm birth is associated with significant perinatal morbidity and mortality. The fetal fibronectin test (fFN) is used to manage women presenting with threatened preterm labour (TPTL). Aim: To evaluate the use of fFN in women presenting with TPTL with regard to hospital admission, tertiary hospital transfer and use of tocolytics and steroids in our hospital, against recommended guidelines. The ability of fFN <10 ng/mL, 10–49 ng/mL, 50–199 ng/mL and >200 ng/mL to predict outcome was also examined. Material and Methods: This was a single‐centre retrospective study from January 2015 to June 2017. All women who presented to Ipswich hospital, a level two facility for births at >32 weeks of gestation, between 23 and 346 weeks of gestation with TPTL and who had fFN tests were included in the study. Results: Fetal fibronectin <50 ng/mL had a negative predictive value of 93.5% (95% CI 86.5–97.1). Despite this assurance, one in four presentations resulted in hospital admission and nearly one in ten in steroids and tocolysis administration. Birth <34 weeks was 0% for fFN <10 and 2% for women with fFN levels <200 ng/mL compared to nearly 30% for levels >200 ng/mL. Conclusion: There is noncompliance with use of fFN to its full potential. This small study also provides support for the use of a 200 ng/mL cut‐off fFN level for birth <34 weeks. This would avoid the need to transfer to a tertiary facility many women who present with TPTL. [ABSTRACT FROM AUTHOR]

Objective: To validate the utility of fetal fibronectin (fFN) and cervical length (CL) in predicting preterm delivery among symptomatic nulliparous women.Methods: A retrospective cohort study of nulliparous women who presented with uterine contractions, abdominal pain, or cervical change at 21-34 gestational weeks at Fukushima Medical University Hospital, Japan, between 2008 and 2017. fFN (categorized as <50 ng/dL, 50-199 ng/dL, >200 ng/dL) and CL (≥15 mm or <15 mm) were evaluated simultaneously. Adjusted odds ratios (aORs) and confidence intervals (CIs) for preterm delivery before 37 or 34 weeks, and delivery within 28 or 14 days were calculated (references: fFN, <50 ng/dL; CL, ≥15 mm).Result: Among 285 women who met the study criteria, CL less than 15 mm was a risk factor for preterm delivery before 37 (aOR, 4.1; 95% CI, 1.1-6.7) and 34 (aOR, 6.8; 95% CI, 2.3-20.2) weeks. fFN of 200 ng/dL or higher was a risk factor for delivery within 28 (aOR, 19.8; 95% CI, 4.3-90.2) and 14 (aOR, 10.8; 95% CI, 1.7-67.6) days.Conclusion: Among symptomatic nulliparous women, short CL was found to be a risk factor for preterm delivery and higher fFN levels were related to short gestational latency. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the risk of intra-amniotic infection/inflammation and spontaneous preterm delivery (SPTD) varies as a function of the concentration of cervical fetal fibronectin (fFN) in patients with preterm labor and intact membranes. Methods: This prospective study included 180 patients with preterm labor and intact membranes who had a sample collected for quantitative fFN measurement and underwent amniocentesis. Amniotic fluid was cultured for aerobic and anaerobic bacteria and genital mycoplasmas. Intra-amniotic inflammation was defined as an amniotic fluid matrix metalloproteinase-8 concentration >23 ng/mL. Results: (1) The prevalence of intra-amniotic infection/inflammation and SPTD within 7 days was 32.2% (58/180) and 33.9% (61/178), respectively; (2) The higher the fFN concentration, the greater the risk of intra-amniotic infection/inflammation and SPTD within 7 days (P<0.001, respectively); (3) An fFN concentration 150 ng/mL had a better diagnostic performance than an fFN 50 ng/mL in the identification of intra-amniotic infection/inflammation and SPTD within 7 days; (4) Among the patients with an fFN <50 ng/mL, intra-amniotic infection/inflammation was identified in 7.6% (6/79) of patients and 66.7% (4/6) delivered within 7 days. Conclusion: The higher the concentration of fFN, the greater the risk of intra-amniotic infection/inflammation and SPTD in patients with preterm labor and intact membranes. [ABSTRACT FROM AUTHOR]

Objective: To compare fetal fibronectin (fFN) assessment, ultrasound parameters, and Bishop score in the prediction of successful induction of labor at term when cervix is unfavorable. Materials and Methods: Seventy-three nulliparous women undergoing labor induction at term with Bishop score less than 5 were enrolled in this study. Successful labor induction was defined as vaginal delivery occurring within 24 hours of initiation of induction. fFN obtained from vaginal secretion was measured by immunoassay. Results: Patients who delivered within 24 hours (n = 33) differed significantly from the remaining patients by a positive fFN (84.8% vs. 15.2%, p = 0.002). The mean cervical length or Bishop scores were not statistically different between women who delivered vaginally before 24 hours of induction and those who did not (28.9 mm vs. 27.9 mm, p = 0.468 and 3.3 vs. 3.2, p = 0.928, respectively). Binary logistic regression analysis showed only the fFN immunoassay to be an independent statistically significant predictor of vaginal delivery within 24 hours of induction (odds ratio 6.168; 95% confidence interval 1.897–20.059; p = 0.002). A positive fibronectin assay had a sensitivity and specificity of 84.9% and 50%, respectively. Conclusions: In cases with unfavorable cervix, presence of vaginal fFN predicts the success of labor induction.

Spontaneous preterm birth is a syndrome triggered by multiple mechanisms. In view of the pathophysiological heterogeneity of preterm birth, a single biomarker cannot show the required high negative and positive predictive values. From a clinical point of view, anamnesis, sonographic measurement of cervical length, and placental alpha-microglobulin-1 (PAMG-1) testing from cervico-vaginal secretion are established. Further prospective, large-scale longitudinal studies must validate the combined use of new biomarkers. [ABSTRACT FROM AUTHOR]

Abstract Preterm birth is an important cause of neonatal morbidity and mortality and has long term adverse health consequences. Worldwide, close to 15 million babies are born preterm each year, and there is no sign that the rate of preterm birth is slowing. A history of a previous spontaneous preterm birth is a significant risk factor for a subsequent spontaneous preterm birth; identifying these women provides an opportunity to optimise care in future pregnancies. Antenatal identification of women at the highest risk of preterm birth is challenging, as tests that accurately identify asymptomatic women who go on to deliver preterm are lacking. Furthermore, the short- and long-term benefits of interventions such as cerclage and progesterone remain unclear. Research is underway to develop biomarkers that can accurately predict women who will deliver preterm. However, without effective strategies that diminish rates of preterm birth and improve perinatal outcomes, the clinical role of these tests is less well defined. [ABSTRACT FROM AUTHOR]

Objective: To assess the accuracy of placental alpha microglobulin-1 (PAMG-1), fetal fibronectin (fFN) and phosphorylated insulin-like growth factor-binding protein-1 (phIGFBP-1) tests in predicting spontaneous preterm birth (sPTB) within 7 days of testing in women with symptoms of preterm labor, through a systematic review and meta-analysis of the literature. The test performance of each biomarker was also assessed according to pretest probability of sPTB ≤ 7 days.Methods: The Cochrane, MEDLINE, PubMed and ResearchGate bibliographic databases were searched from inception until October 2017. Cohort studies that reported on the predictive accuracy of PAMG-1, fFN and phIGFBP-1 for the prediction of sPTB within 7 days of testing in women with symptoms of preterm labor were included. Summary receiver-operating characteristics (ROC) curves and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and positive (LR+) and negative (LR-) likelihood ratios were generated using indirect methods for the calculation of pooled effect sizes with a bivariate linear mixed model for the logit of sensitivity and specificity, with each diagnostic test as a covariate, as described by the Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy.Results: Bivariate mixed model pooled sensitivity of PAMG-1, fFN and phIGFBP-1 for the prediction of sPTB ≤ 7 days was 76% (95% CI, 57-89%), 58% (95% CI, 47-68%) and 93% (95% CI, 88-96%), respectively; pooled specificity was 97% (95% CI, 95-98%), 84% (95% CI, 81-87%) and 76% (95% CI, 70-80%) respectively; pooled PPV was 76.3% (95% CI, 69-84%) (P < 0.05), 34.1% (95% CI, 29-39%) and 35.2% (95% CI, 31-40%), respectively; pooled NPV was 96.6% (95% CI, 94-99%), 93.3% (95% CI, 92-95%) and 98.7% (95% CI, 98-99%), respectively; pooled LR+ was 22.51 (95% CI, 15.09-33.60) (P < 0.05), 3.63 (95% CI, 2.93-4.50) and 3.80 (95% CI, 3.11-4.66), respectively; and pooled LR- was 0.24 (95% CI, 0.12-0.48) (P < 0.05), 0.50 (95% CI, 0.39-0.64) and 0.09 (95% CI, 0.05-0.16), respectively. The areas under the ROC curves for PAMG-1, fFN and phIGFBP-1 for sPTB ≤ 7 days were 0.961, 0.874 and 0.801, respectively.Conclusions: In the prediction of sPTB within 7 days of testing in women with signs and symptoms of preterm labor, the PPV of PAMG-1 was significantly higher than that of phIGFBP-1 or fFN. Other diagnostic accuracy measures did not differ between the three biomarker tests. As prevalence affects the predictive performance of a diagnostic test, use of a highly specific assay for a lower-prevalence syndrome such as sPTB may optimize management. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: To estimate the association between a positive fetal fibronectin (fFN) and spontaneous preterm birth (SPTB) in twin pregnancies with a shortened cervical length (CL).Study Design: Retrospective cohort study of asymptomatic twin pregnancies managed by a single MFM practice from 2005 to 2016. We included all women with a shortened CL ≤25 mm at 22-28 weeks, and compared outcomes between women with a positive and negative fFN result.Results: One hundred fifty-five patients were included, 129 (83.2%) of whom had a negative fFN and 26 (16.8%) of whom had a positive fFN. Baseline characteristics were similar between groups, except for the CL at the time of diagnosis of short cervix (15 mm in the positive fFN group versus 20 mm in the negative fFN group, p = .002). The risk of SPTB <32 weeks was significantly higher in the positive fFN group (46.2 versus 12.6%, aOR 3.54, 95% CI 1.26, 9.92) and the mean gestational age at delivery was significantly earlier (31.1 versus 35.2 weeks, p < .001).Conclusions: In asymptomatic women with twin pregnancies and a shortened CL, a positive fFN is significantly associated with SPTB and can modify the risk substantially. If performing a screening CL assessment in a twin pregnancy, fFN testing should be done concurrently. [ABSTRACT FROM AUTHOR]

Objective: To estimate the association between a positive fetal fibronectin (fFN) and spontaneous preterm birth (SPTB) in twin pregnancies with a shortened cervical length (CL).Study Design: Retrospective cohort study of asymptomatic twin pregnancies managed by a single MFM practice from 2005 to 2016. We included all women with a shortened CL ≤25 mm at 22-28 weeks, and compared outcomes between women with a positive and negative fFN result.Results: One hundred fifty-five patients were included, 129 (83.2%) of whom had a negative fFN and 26 (16.8%) of whom had a positive fFN. Baseline characteristics were similar between groups, except for the CL at the time of diagnosis of short cervix (15 mm in the positive fFN group versus 20 mm in the negative fFN group, p = .002). The risk of SPTB <32 weeks was significantly higher in the positive fFN group (46.2 versus 12.6%, aOR 3.54, 95% CI 1.26, 9.92) and the mean gestational age at delivery was significantly earlier (31.1 versus 35.2 weeks, p < .001).Conclusions: In asymptomatic women with twin pregnancies and a shortened CL, a positive fFN is significantly associated with SPTB and can modify the risk substantially. If performing a screening CL assessment in a twin pregnancy, fFN testing should be done concurrently. [ABSTRACT FROM AUTHOR]

Introduction: Fetal fibronectin (fFN) is a validated test for assessing risk of preterm birth for women presenting with symptoms. Our aim was to evaluate the accuracy of fFN to detect the risk of preterm birth in asymptomatic women.Material and Methods: Searches were conducted to identify studies where fFN was performed in asymptomatic women beyond 22 weeks' gestation. EMBASE, MEDLINE, CINHAL, AMED and BNI were searched between 2005 and 2017. Studies before 2005 were identified from a published systematic review. Women were grouped as singleton pregnancies, with and without risk factors for preterm birth, and multiple pregnancy. Quality assessment was performed using QUADAS-2. When possible, data were pooled using a hierarchical, bivariate random effects model.Results: Fifteen studies met the inclusion criteria: six studies of singleton pregnancies in women without risk factors (1236 women), four in women with risk factors for preterm birth (2628 women) and five studies were of multiple pregnancy (1427 women). The pooled sensitivity and specificity of fFN in "no risk factors singletons" were 0.48 (95% CI 0.20-0.77), and 0.96 (95% CI 0.86-0.99), respectively. The likelihood ratio of a positive test result was 12 (95% CI 4.70-30.68). The pooled sensitivity and specificity of fFN in "risk factors singletons" were 0.34 (95% CI 0.24-0.43), and 0.91 (95% CI 0.88-0.93). The accuracy of fFN in multiple pregnancies was inconclusive.Conclusion: Our findings suggest in asymptomatic singleton pregnancies without risk factors, a positive fFN result indicates a large shift from pre- to post-test probability, possibly identifying women at increased risk of preterm birth. [ABSTRACT FROM AUTHOR]

Objective: To compare the performance of the placental alpha microglobulin-1 (PAMG-1) and fetal fibronectin (fFN) tests for the prediction of spontaneous preterm delivery in patients presenting to an emergency obstetric unit with threatened preterm labor, by conducting a retrospective audit of patient medical records from separate 1-year periods during which either fFN or PAMG-1 was used as the standard-of-care biochemical test.Methods: This was a retrospective cohort study based on chart review of electronic medical records of women with threatened preterm labor presenting at a level-III maternity hospital over two different periods: (1) the 'baseline' period (year 2012), during which the qualitative fFN test with a cut-off of 50 ng/mL was used as the standard-of-care biochemical test for the risk assessment of preterm delivery, and (2) the 'comparative' period (year 2016), during which the PAMG-1 test with a cut-off of 1 ng/mL was used as the standard-of-care biomarker test. Patients with a singleton pregnancy between 24 + 0 and 34 + 6 weeks' gestation with symptoms of early preterm labor, clinically intact membranes and cervical dilatation < 3 cm, who did not have a medically indicated preterm delivery within 14 days of testing, were selected for chart review and included in the analysis. Key parameters used for the analysis were biochemical test results, time of testing and time of delivery. Positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, and positive and negative likelihood ratios (LR+ and LR-) for the prediction of spontaneous preterm delivery ≤ 7 and ≤ 14 days of presentation were calculated for the PAMG-1 and fFN tests.Results: Four hundred and twenty patients were identified as having presented with threatened preterm labor during the baseline period, of whom 378 (90.0%) met the eligibility criteria. Of these, 38 (10.1%) were fFN positive and 10 (2.6%) had spontaneous preterm delivery ≤ 7 days of presentation. PPV, NPV, LR+ and LR- of fFN were 7.9%, 97.9%, 3.2 and 0.8, respectively, for spontaneous preterm delivery ≤ 7 days. Four hundred and ten patients were identified as having presented with threatened preterm labor during the comparative period and 367 (89.5%) subjects met the eligibility criteria. Of these, 17 (4.6%) were PAMG-1 positive and 12 (3.3%) had spontaneous preterm delivery ≤ 7 days of presentation. PAMG-1 PPV and NPV were 35.3% and 98.3%, respectively, and LR+ and LR- were 16.1 and 0.5, respectively, for spontaneous preterm delivery ≤ 7 days.Conclusions: Before switching to PAMG-1, fFN was the standard-of-care test for the risk assessment of spontaneous preterm delivery. This retrospective audit of each test's performance over separate 1-year periods shows that we were more than twice as likely to get a positive fFN test than a positive PAMG-1 test, while the rate of discharging women who ultimately delivered spontaneously within 14 days of testing was not affected. Furthermore, a positive PAMG-1 test was more than four times more reliable than a positive fFN test in predicting imminent spontaneous preterm delivery. The use of a more reliable biomarker that is associated with fewer false-positive results could lead to a reduction in unnecessary admissions, interventions and use of hospital resources. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the cost-effectiveness of combining cervical-length (CL) measurement and fetal fibronectin (fFN) testing in women with symptoms of preterm labor between 24 and 34 weeks' gestation.Methods: This was a model-based cost-effectiveness analysis evaluating seven test-treatment strategies based on CL measurement and/or fFN testing in women with symptoms of preterm labor from a societal perspective, in which neonatal outcomes and costs were weighted. Estimates of disease prevalence, test accuracy and costs were based on two recently performed nationwide cohort studies in The Netherlands.Results: Strategies using fFN testing and CL measurement separately to predict preterm delivery are associated with higher costs and incidence of adverse neonatal outcomes compared with strategies that combine both tests. Additional fFN testing when CL is 15-30 mm was considered cost effective, leading to a cost saving of €3919 per woman when compared with a treat-all strategy, with a small deterioration in neonatal health outcomes, namely one additional perinatal death and 21 adverse outcomes per 10 000 women with signs of preterm labor (incremental cost-effectiveness ratios €39 million and €1.9 million, respectively). Implementing this strategy in The Netherlands, a country with about 180 000 deliveries annually, could lead to an annual cost saving of between €2.4 million and €7.6 million, with only a small deterioration in neonatal health outcomes.Conclusion: In women with symptoms of preterm labor at 24-34 weeks' gestation, performing additional fFN testing when CL is between 15 and 30 mm is a viable and cost-saving strategy. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objectives Perturbation of the choriodecidual space before the onset of spontaneous preterm birth (sPTB) could lead to a concomitant rise in both cervicovaginal fluid (CVF) cytokine and fetal fibronectin (FFN), and assessing the concentrations of both markers could improve the prediction of sPTB (delivery before 37 completed weeks of gestation). Therefore, we prospectively determined mid-trimester changes in CVF cytokine and FFN concentrations, and their predictive capacity for sPTB in asymptomatic pregnant women. Study design CVF collected at 20 +0 –22 +6 weeks (n = 47: Preterm-delivered = 22, Term-delivered = 25) and 26 +0 –28 +6 weeks (n = 50: Preterm-delivered = 17, Term-delivered = 33) from 63 asymptomatic pregnant women at risk of sPTB were examined. Cytokine and FFN concentrations were determined by multiplexed bead-based immunoassay and 10Q Rapid analysis (Hologic, MA, USA) respectively. The 20 +0 –22 +6 /26 +0 –28 +6 weeks ratios of cytokines and FFN concentrations were compared between preterm- and term-delivered women using Receiver Operating Characteristics curves to predict sPTB. Also, bacterial 16S rDNA from 64 samples (20 +0 –22 +6 weeks n = 36, 26 +0 –28 +6 weeks n = 28) was amplified by polymerase chain reaction to determine associations between vaginal microflora, cytokine and FFN concentrations. Results Changes in RANTES and IL-1β concentrations between 20 +0 –22 +6 and 26 +0 –28 +6 weeks, expressed as a ratios, were predictive of sPTB, RANTES (AUC = 0.82, CI = 0.62–0.94) more so than IL-1β (AUC = 0.71, CI = 0.53–0.85) and FFN (not predictive). Combining these markers (AUC = 0.83, CI = 0.63–0.95) showed similar predictive capacity as RANTES alone. FFN concentrations at 26 +0 –28 +6 weeks correlated with IL-1β ( r  = 0.4, P  = 0.002) and RANTES ( r  = 0.3, P  = 0.03). In addition, there was increased prevalence of vaginal anaerobes including Bacteroides , Fusobacterium and Mobiluncus between gestational time points in women who experienced sPTB compared to the term women ( P  = 0.0006). Conclusions CVF RANTES and IL-1β in mid-trimester of pregnancy correlate with quantitative FFN. The levels of CVF RANTES and IL-1β decline significantly in women who deliver at term unlike women who deliver preterm. This observation suggests that sPTB may be characterised by sustained choriodecidual inflammation and may have clinical value in serial screening for sPTB if confirmed by larger studies. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to evaluate the association of screening tests for preterm birth (short cervical length [CL], positive fetal fibronectin (FFN), and amniotic fluid [AF] sludge) in twin gestations with histologic evidence of placental inflammation. Study Design Historical cohort study of 596 twin gestations delivered in a single maternal-fetal medicine practice with CL and FFN testing from 22 to 256/7 weeks. A short CLwas defined as ≤25 mm. Placental lesions evaluated were chronic and acute membrane inflammation and funisitis. Fischer's exact test and logistic regression were used. Results None of the screening tests was associated with chronic inflammation. All were associated with acute inflammation. On regression analysis, a short CL and positive FFN remained independently associated with acute inflammation (adjusted odds ratio [aOR]: 5.66 and 2.51, respectively) and funisitis (aOR: 5.66 and 7.17, respectively). AF sludge was not independently associated with acute inflammation nor funisitis. Conclusion In twin gestations, a short CL and a positive FFN at 22 to 26 weeks are associated with acute but not chronic inflammation on placental histology. These findings imply that mechanisms underlying preterm birth in twins that result in positive screening tests weeks prior to delivery are not reflected as chronic placental inflammation. Therefore, pathologic interpretation of etiologic mechanisms for preterm birth may be limited using solely histologic reports. [ABSTRACT FROM AUTHOR]

Objective: To increase adherence to a local hospital clinical practice guideline for the use of fetal fibronectin testing in women presenting with symptoms of threatened preterm labour.Study Design: A quality improvement project using a multi-faceted implementation strategy.Setting: National Women's Health, Auckland City Hospital; a tertiary referral maternity unit in Auckland, New Zealand.Population: All obstetricians, junior obstetric doctors and hospital employed midwives.Methods: A pre-education audit and survey, compulsory interactive educational intervention with audit feedback and provision of reminders followed by a post-education audit and survey one year later.Main Outcome Measures: Number of fetal fibronectin tests performed, proportion of tests performed meeting clinical criteria for testing and proportion of results managed according to hospital guideline.Results: There was a 25% increase in the number of tests performed with an increase in the proportion that met clinical criteria for testing, 76% (31/41)-93% (51/55) (OR 4.1, 95% CI 1.2-14.2). Adherence to guidelines for clinical management according to fFN results changed over time, 80% (33/41)-95% (52/55) (OR 4.2, 95% CI 1.04-17.0). Clinician knowledge on some (but not all) indications for fFN testing improved. Education and reminders did not improve understanding of clinical scenarios that may result in a false positive fFN test.Conclusions: A multi-faceted approach of audit and clinician feedback, interactive education and reminders supports the implementation of a clinical practice guideline for the use of fFN as a preterm birth prediction test for women presenting with symptoms of threatened preterm labour. [ABSTRACT FROM AUTHOR]

Introduction: Preterm delivery remains a challenge in Obstetrics as it is responsible for significant cause of perinatal morbidity and mortality. At present there is no standard test for prediction of preterm labour for timely referral to a center with NICU facilities. Aim: To evaluate the effectiveness of the cervical phosphorylated insulin like growth factor binding protein-1(phIGFBP-1), cervical length measurement and combination of phIGFBP-1 with cervical length for Predicting Preterm Labour (PTL). Materials and Methods: It was a observational prospective study done from January 2014 to April 2015 in Department of Obstetrics and Gynaecology, NDMC Medical College and Hindu Rao Hospital, Delhi, India. A total of 100 women with singleton pregnancy, between 24 and 36 weeks of gestation with complaint of uterine contractions were randomly selected. These women were subjected to detect phIGFBP-1 in cervical secretions and cervical length measurement by Transvaginal Sonography (TVS). Result of the test, cervical length and time lapse between test and delivery was noted and the results were analysed. The cervical length less than 25 mm was used as a cut off point for predicting pre-term delivery. Data was analysed using SPSS software version 20.0. Results: The Negative Predictive Value (NPV) of phIGFBP-1 and cervical length was similar (95.2% vs 94.05%) respectively for prediction of preterm labour within one week of admission and 93.92% vs 94.80% at 37 weeks of gestational age. Combined test had higher NPV of 96.38% at 34 weeks of gestation and 94% within two days of admission. Positive Predictive Value (PPV) was low for both the test and combining the two-test did not have any advantage as far as PPV was concerned. Receiver Operating Characteristic (ROC) curve showed that the combined test had a superior result in predicting PTL compared to either phIGFBP-1 or cervical length. The combined test had steepest ROC curve at < 34 weeks of gestation (AUC-0.83 with 95% CI). Conclusion: The phIGFBP-1 test and cervical length have an almost equivalent ability to predict preterm delivery independently. The combined use of phIGFBP-1 and TVS for cervical length shows an increase in efficacy in predicting preterm labour.