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Objective: A recent randomized clinical trial (ProTWIN) showed that a cervical pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow-up study, the long-term developmental outcome of these children was evaluated at 3 years' corrected age., Methods: This was a follow-up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical pessary or no intervention. Current follow-up and analysis were limited to mothers with a mid-trimester CL < 38 mm (78 women (157 children) in the pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) assessment. Death after randomization or neurodevelopmental disability (Bayley-III score of ≤ 85, 1 SD below mean) rates were compared between the pessary and control groups, according to the intention-to-treat principle and using multiple imputation for missing data. Mean Bayley-III scores in surviving children were also assessed. A linear mixed-effects model was used to adjust for correlation between children of one mother., Results: From the time of entry in the ProTWIN trial until follow-up at 3 years of age, a total of 27 children had died (six (5%) in the pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04-0.48). Bayley-III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09-0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation., Conclusion: In women with twin pregnancy and a CL < 38 mm, the use of a cervical pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd., (Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.)

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., (Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.)

Objective: To assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy., Methods: The study design comprised an economic analysis of data from a randomized clinical trial evaluating cervical pessaries (ProTWIN). Women with a multiple pregnancy were included and an economic evaluation was performed from a societal perspective. Costs were estimated between the time of randomization and 6 weeks postpartum. The prespecified subgroup of women with a cervical length (CL) < 25(th) centile (< 38 mm) was analyzed separately. The primary endpoint was poor perinatal outcome occurring up to 6 weeks postpartum. Direct medical costs and health outcomes were estimated and incremental cost-effectiveness ratios for costs to prevent one poor outcome were calculated., Results: Mean costs in the pessary group (n = 401) were € 21,783 vs € 21,877 in the group in which no pessary was used (n = 407) (difference, -€ 94; 95% CI, -€ 5975 to € 5609). In the prespecified subgroup of women with a CL < 38 mm we demonstrated a significant reduction in poor perinatal outcome (12% vs 29%; RR, 0.40; 95% CI, 0.19-0.83). Mean costs in the pessary group (n = 78) were € 25,141 vs € 30,577 in the no-pessary group (n = 55) (difference, -€ 5436 (95% CI, -€ 11,001 to € 1456). In women with a CL < 38 mm, pessary treatment was the dominant strategy (more effective and less costly) with a probability of 94%., Conclusion: Cervical pessaries in women with a multiple pregnancy involve costs comparable to those in women without pessary treatment. However, in women with a CL < 38 mm, treatment with a cervical pessary appears to be highly cost-effective., (Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.)

Objective: To perform a systematic review and meta-analysis to assess the predictive capacity of transvaginal sonographic assessment of the cervix for the outcome of induction of labor., Methods: We searched MEDLINE, EMBASE and the Cochrane Library, and manually searched reference lists of review articles and eligible primary articles. Studies in all languages were eligible if published in full. Two reviewers independently selected studies and extracted data on study characteristics, quality and test accuracy. We then calculated pooled sensitivities and specificities (with 95% CIs) and summary receiver-operating characteristics (sROC) curves. Outcome measures were test accuracy of sonographically measured cervical length and cervical wedging for Cesarean section, not achieving vaginal delivery within 24 h and not achieving active labor., Results: We included 31 studies reporting on both cervical length and outcome of delivery. The quality of the included studies was mediocre. Sensitivity of cervical length in the prediction of Cesarean delivery ranged from 0.14 to 0.92 and specificity ranged from 0.35 to 1.00. The estimated sROC curve for cervical length indicated a limited predictive capacity in the prediction of Cesarean delivery. Summary estimates of sensitivity/specificity combinations of cervical length at different cut-offs for Cesarean delivery were 0.82/0.34, 0.64/0.74 and 0.13/0.95 for 20, 30 and 40 mm, respectively. For cervical wedging in the prediction of failed induction of labor summary point estimates of sensitivity/specificity were 0.37/0.80., Conclusions: Cervical length and cervical wedging as measured sonographically at or near term have moderate capacity to predict the outcome of delivery after induction of labor., (Copyright © 2013 ISUOG. Published by John Wiley & Sons Ltd.)

Objective: To evaluate the accuracy of antenatal sonographic measurement of lower uterine segment (LUS) thickness in the prediction of risk of uterine rupture during a trial of labor (TOL) in women with a previous Cesarean section (CS)., Methods: PubMed and EMBASE were searched to identify articles published on the subject of sonographic LUS measurement and occurrence of a uterine defect after delivery. Four independent researchers performed identification of papers and data extraction. Selected studies were scored on methodological quality, and sensitivity and specificity of measurement of LUS thickness in the prediction of a uterine defect were calculated. We performed bivariate meta-analysis to estimate summary receiver-operating characteristics (sROC) curves., Results: We included 21 studies with a total of 2776 analyzed patients. The quality of included studies was good, although comparison was difficult because of heterogeneity. The estimated sROC curves showed that measurement of LUS thickness seems promising in the prediction of occurrence of uterine defects (dehiscence and rupture) in the uterine wall. The pooled sensitivity and specificity of myometrial LUS thickness for cut-offs between 0.6 and 2.0 mm was 0.76 (95% CI, 0.60-0.87) and 0.92 (95% CI, 0.82-0.97); cut-offs between 2.1 and 4.0 mm reached a sensitivity and specificity of 0.94 (95% CI, 0.81-0.98) and 0.64 (95% CI, 0.26-0.90). The pooled sensitivity and specificity of full LUS thickness for cut-offs between 2.0 and 3.0 mm was 0.61 (95% CI, 0.42-0.77) and 0.91 (95% CI, 0.80-0.96); cut-offs between 3.1 and 5.1 mm reached a sensitivity and specificity of 0.96 (95% CI, 0.89-0.98) and 0.63 (95% CI, 0.30-0.87)., Conclusions: This meta-analysis provides support for the use of antenatal LUS measurements in the prediction of a uterine defect during TOL. Clinical applicability should be assessed in prospective observational studies using a standardized method of measurement., (Copyright © 2013 ISUOG. Published by John Wiley & Sons Ltd.)

Objectives: Measurement of endometrial thickness is an important tool in the assessment of women with postmenopausal bleeding, but the role of endometrial thickness measurement by ultrasound in asymptomatic women is unclear. The aims of this study were to determine: (1) the normal endometrial thickness measured by ultrasonography, (2) the prevalence of serious endometrial pathology and (3) the sensitivity and specificity of endometrial thickness measurement by transvaginal ultrasonography (TVS) for diagnosing premalignant and malignant endometrial disease in asymptomatic postmenopausal women., Methods: A MEDLINE and EMBASE search (from inception to January 2011) was performed. Articles reporting on endometrial thickness measurement in the diagnosis of endometrial carcinoma and atypical hyperplasia in asymptomatic postmenopausal women not using hormone replacement therapy (HRT) were selected. Endometrial thickness and the prevalence of endometrial (pre)malignancies were recorded. If possible, 2 × 2 tables were extracted., Results: Thirty-two studies reporting on 11100 women were included. The estimated mean endometrial thickness was 2.9 mm (95% CI, 2.6-3.3 mm). The pooled estimated prevalences of endometrial carcinoma and atypical endometrial hyperplasia were 0.62% (95% CI, 0.42-0.82%) and 0.59% (95% CI, 0.22-0.96%), respectively. Summary estimates for sensitivity and specificity of TVS endometrial thickness measurement in the prediction of endometrial carcinoma were 0.83 (95% CI, 0.19-1.00) and 0.72 (95% CI, 0.23-0.95) for a 5-mm cut-off and 0.33 (95% CI, 0.04-0.85) and 0.94 (95% CI, 0.92-0.96) for a 6-mm cut-off., Conclusions: The results from this systematic review do not justify the use of endometrial thickness as a screening test for endometrial carcinoma and atypical endometrial hyperplasia in asymptomatic postmenopausal women not using HRT., (Copyright © 2012 ISUOG. Published by John Wiley & Sons, Ltd.)

Objective: We performed a systematic review to determine whether sonographic assessment of occipital position of the fetal head can contribute to the prediction of the mode of delivery., Methods: We performed a systematic literature search of electronic databases from inception to May 2011. Two reviewers independently extracted data from the included studies. We used a bivariate model to estimate point estimates for sensitivity and specificity curves for the outcome Cesarean delivery. Eligible studies were cohort studies or cross-sectional studies that reported on both the position of the fetal head, as assessed by ultrasound, before or at the beginning of active labor as well as the outcome of labor in women at term., Results: We included 11 primary articles reporting on 5053 women, of whom 898 had a Cesarean section. All studies indicated disappointing values for sensitivity and specificity in the prediction of Cesarean section. Summary point estimates of sensitivity and specificity were 0.39 (95% CI, 0.32-0.48) and 0.71 (95% CI, 0.67-0.74), respectively., Conclusion: Sonographic assessment of occipital position of the fetal head before delivery should not be used in the prediction of mode of delivery., (Copyright © 2012 ISUOG. Published by John Wiley & Sons, Ltd.)

Objectives: To review the literature on cervical length as a predictor of preterm birth in asymptomatic women with a multiple pregnancy., Methods: We searched MEDLINE, Embase and reference lists of included articles to identify all studies that reported on the accuracy of cervical length for predicting preterm birth in asymptomatic women with a multiple pregnancy. We scored study characteristics and study quality, and extracted data in order to construct two-by-two tables cross-classifying cervical length and preterm delivery. Meta-analysis using a bivariate model was performed. Summary receiver-operating characteristics (ROC) curves were generated for various test characteristics and outcome definitions., Results: We found 21 studies reporting on 2757 women. There was a large variation in gestational age at measurement, cut-off point for cervical length and definition of preterm birth. The summary ROC curve indicated a good predictive capacity of short cervical length for preterm birth. Summary estimates of sensitivity and specificity for preterm birth before 34 weeks' gestation were 78% and 66%, respectively, for 35 mm, 41% and 87% for 30 mm, 36% and 94% for 25 mm and 30% and 94% for 20 mm., Conclusions: In women with a multiple pregnancy, second-trimester cervical length is a strong predictor of preterm birth. In the absence of effective preventive strategies, there is currently no place in clinical practice for cervical length measurement in this population. However, future studies should evaluate preventive interventions in women with multiple pregnancies and a short cervix, and cervical length should be measured in any trial studying preventive strategies in multiple pregnancies., (Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.)

Objective: To investigate if ductus venosus (DV) pulsatility index for veins (PIV) and a-wave measurements can increase the accuracy of first-trimester Down syndrome screening in a high-risk population., Methods: The database of our fetal medicine unit was searched for all cases at increased first-trimester Down syndrome risk. Multivariable logistic regression was used to construct a prediction rule for chromosomal anomalies at any given maternal age, nuchal translucency multiples of the median (NT-MoM) and DV-PIV MoM. The discriminative ability of the model was assessed by using receiver-operating characteristics (ROC) analysis., Results: The study population included 445 fetuses. DV-PIV was increased (≥ 95(th) percentile) in 239 (54%) and DV a-wave was abnormal in 187 fetuses (42%). In this cohort, 80% of all chromosomal anomalies were identified by an increased DV-PIV and 68% by an abnormal a-wave. The odds of chromosomal anomalies increased by a factor of 4.2 per MoM increase in DV-PIV, adjusted for NT and maternal age. The area under the ROC curve for the prediction of chromosomal anomalies was 0.79. After correction for DV-PIV, DV a-wave did not significantly add to the prediction of chromosomal anomalies., Conclusion: In a population of fetuses at increased first-trimester risk for Down syndrome, the combination in a logistic regression model of NT, DV-PIV and maternal age can improve the accuracy of screening for trisomy 21 and other chromosomal anomalies. This is the first study that models the additional value of DV-PIV as a continuous variable to NT measurement alone in a high-risk first-trimester population., (Copyright © 2010 ISUOG. Published by John Wiley & Sons, Ltd.)