Cost-effectiveness of universal routine sonographic cervical-length measurement at 19 to 25 weeks' gestation.

BACKGROUND: National second-trimester scanning of cervical length was introduced in Israel in 2010, and in the decade thereafter, a significant systematic reduction in preterm birth and in the delivery of low birthweight babies was found among singletons. OBJECTIVE: In this study, we sought to estimate the cost-effectiveness of a national policy mandating second-trimester cervical length screening by ultrasound, followed by vaginal progesterone treatment for short cervical length in comparison with no screening strategy. STUDY DESIGN: We constructed a decision model comparing 2 strategies, namely (1) universal cervical length screening, and (2) no screening strategy. This study used the national delivery registry of Israel's Ministry of Health. All women diagnosed with a second-trimester cervical length <25 mm were treated with vaginal progesterone and were monitored with a bimonthly ultrasound scan for cervical dynamics and threat of early delivery. Preterm birth prevalence associated with short cervical length, the efficacy of progesterone in preterm birth prevention, and the accuracy of cervical length measurements were derived from previous studies. The cost of progesterone and bimonthly sonographic surveillance, low birthweight delivery, newborn admission to intensive care units, the first-year costs of managing preterm birth and low birthweight, and instances of handicaps and the cost of their follow-up were extracted from the publicly posted registry of Israel's Ministry of Health and Israel Social Securities data. Monte Carlo simulations decision tree mode, Tornado diagrams, and 1- and 2-way sensitivity analyses were implemented and the base case and sensitivity to parameters that were predicted to influence cost-effectiveness were calculated. RESULTS: Without cervical length screening, the discounted quality-adjusted life years were 30.179, and with universal cervical length screening, it increased to 30.198 (difference of 0.018 quality-adjusted life years). The average cost of no screening for cervical length strategy was $1047, and for universal cervical length screening, it was reduced to $998. The calculated incremental cost-effectiveness ratio was -$2676 per quality-adjusted life year (dividing the difference in costs by the difference in quality-adjusted life years). Monte Carlo simulation of cervical length screening of 170,000 singleton newborns (rounded large number close to the number of singleton newborns in Israel) showed that 95.17% of all babies were delivered at gestational week ≥37 in comparison with 94.46% of babies with the no screening strategy. Given 170,000 singleton births, the national savings of screening for short cervical length when compared with no cervical length screening amounted to $8.31M annually, equating to $48.84 for a base case, and the incremental cost-effectiveness ratio for each case of low birthweight or very low birthweight avoided was -$14,718. A cervical length <25 mm was measured for 30,090 women, and of those, 24,650 were false positives. The major parameters that affected the incremental cost-effectiveness ratio were the incidence of preterm birth, the specificity of cervical length measurements, and the efficacy of progesterone treatment. At a preterm birth incidence of <3%, universal screening does not lead to a cost saving. CONCLUSION: National universal cervical length screening should be incorporated into the routine anomaly scan in the second trimester, because it leads to a drop in the incidence of preterm birth and low birthweight babies in singleton pregnancies, thereby saving costs related to the newborn and gaining quality-adjusted life years.

Cervical assessment certification and its impact on performance quality in the context of universal cervical screening.

OBJECTIVE: To assess the impact of the introduction of universal transvaginal cervical screening and certification on the quality of cervical length ultrasound images. METHODS: The present study included a retrospective cohort of singleton pregnancies that underwent transvaginal cervical length measurement at the anatomical scan (180/7 and 236/7 weeks) before (period A, 2015-2017) and after (period B, 2017-2019) the introduction of universal transvaginal cervical length screening. Independent observers blindly evaluated the images obtained for cervical length using a qualitative scoring method based on five criteria, according to the Fetal Medicine Foundation. RESULTS: In all, 6013 patients met the inclusion criteria, 3333 in period A and 2680 in period B. Maternal characteristics and risk factors for preterm birth were similar between the two periods. The acceptance of transvaginal cervical length measurement in period B was 95.5% in the overall cohort and 100% in the subgroup of high-risk patients. The quality score was significantly higher in period B than in period A. Among the image quality criteria, the anterior/posterior ratio, the correct magnification of the images, and the calipers' placement contributed significantly to the improved quality score in period B. Most of the sonographers performed better in period B, irrespective of the years of experience, but certificate holders obtained higher scores than non-certified sonographers, particularly those in mid-career. The identification of short cervix was significantly higher in period B than in period A. CONCLUSION: The implementation of universal transvaginal cervical length screening and the certification process are associated with improved quality of cervical length images, even among expert sonographers and in the presence of anatomical pitfalls.

Assessment of utero-cervical angle and cervical length as predictors for threatened preterm delivery in singleton pregnancies.

OBJECTIVES: The aim of this study was to evaluate the relationship between the cervix and the threat of preterm labor in singleton pregnancies between gestational weeks less than 37 and greater than 37 weeks in correlation with utero-cervical angle (UCA) and cervical length (CL) measurements. MATERIALS AND METHODS: We conducted a prospective cohort study with UCA and CL measurements in patients with threatened preterm labor (TPL). Primary outcome was differences in UCA and CL measurements in relationship to maternal characteristics and perinatal outcome between groups. Secondary outcome evaluated measurement results and influencing factors for delivery within 7 days, between 1 and 4 weeks and beyond 4 weeks. RESULTS: Overall 152 patients were divided into as study/preterm group (<37 weeks; n = 56) and the control/term group (≥37 weeks; n = 96). Mean gestational age at admission was similar in both groups (30.98 ± 2.83 vs. 30.36 ± 2.63 weeks, p = 0.149) with similar CL (33.9 ± 6.34 vs. 32.02 ± 8.88 mm, p = 0.132), but wider UCA in the preterm group (81.65 ± 16.81° vs. 99.21 ± 22.33°, p < 0.001). Multivariate logistic regression analysis for preterm delivery was significant for nulliparity and UCA measurement. The factor for delivering before 37 gestational weeks within 7 days was the gestational week at admission (p = 0.046). UCA and CL measurements were statistically significant for distinguishing patients for delivery within 7 days and beyond 4 weeks (p = 0.001 for CL and p = 0.0001 for UCA). NPV was found 92.5, 92.2, and 92.3 for UCA >105°, CL ≤30 mm, and Bishop score >3, respectively. CONCLUSION: Combined measurement of TV UCA and CL represents stronger predictors for sPTB ultrasonographically, demonstrating the uterocervical sub-segment maturation before the active onset of labor.

Estimates of avoided costs attributed to a short cervix screening program to prevent preterm birth from the perspective of the Unified Health System (SUS).

OBJECTIVE: To perform an economic cost analysis of the implementation of a short cervix screening program to reduce preterm birth in singleton pregnancies in a short-term time horizon. METHODS: We performed a cost-benefit economic analysis using the P5 trial database, a randomized multicenter clinical trial for prevention of preterm birth. Data collection was conducted from July 2015 to March 2019 in 17 different Brazilian hospitals. We conducted a cost analysis for universal cervical screening in singleton pregnancies between 18 weeks and 22 weeks plus 6 days. In subjects with a cervical length ≤ 25 mm, the analysis incorporated the costs of administering 200 mg/day of vaginal progesterone prophylactically until 36 weeks gestation. These findings were subsequently compared with the economic implications of forgoing cervical screening. The time horizon comprised from birth to 10 weeks postpartum. The outcome was measured monetarily in Brazilian real (R$) from the perspective of the Unified Health System. RESULTS: Among 7,844 women, 6.67% (523) had a cervix ≤ 25 mm. The cost of screening with transvaginal ultrasound and vaginal progesterone for prevention of births with < 34 weeks was estimated at R$ 383,711.36, while non-screening generated an estimated additional cost of R$ 446,501.69 (related to the 29 non-screened preterm deliveries). Thus, screening and prophylaxis would generate a final cost reduction of R$ 62,790.33, constituting a possible cost-benefit strategy. CONCLUSION: Universal short cervix screening for preterm birth has lower costs compared to non-screening within a short-term time horizon, which suggests an interesting benefit-cost ratio. Future studies should consider the cost-effectiveness of prophylactic treatment using sensitivity analyses in different scenarios within the Brazilian health system, as well as analyses that consider the long-term costs associated with preterm births, to robustly justify the implementation of a short cervix screening program.

Third-trimester cervical length assessment for the prediction of spontaneous late preterm birth.

BACKGROUND: The usefulness of cervical length (CL) measurement in asymptomatic pregnancies in the third trimester of pregnancy is not certain. Therefore, the objective of this study was to assess the performance of CL measurement at 31-34 gestational weeks for the prediction of spontaneous late preterm birth (PTB). MATERIALS AND METHODS: This was a prospective study of women with a singleton pregnancy, who had their routine third-trimester scan at 31-34 weeks. The CL was measured transvaginally and was tested, together with maternal demographic and obstetric parameters, for the prediction of late PTB (34 to 36 weeks), using logistic regression and ROC curve analysis. RESULTS: Overall, from a population of 1003 women that consented to participate in the study, 42 (4.2%) delivered at 34-36 gestational weeks. A significant association was identified between gestational age at birth and CL (rho = 0.182, p < .001), and there were significant differences in the CL between cases of late preterm and term births (p < .001). Cervical length alone could predict 17% of late PTB for a 10% false positive rate, corresponding to 22 mm. A model combining CL with parity and method of conception can identify 35% of pregnancies resulting in late PTB, at a false positive rate of 10% (AUC: 0.750; 95% CI: 0.675-0.824). CONCLUSIONS: CL assessment at 31-34 gestational weeks may contribute to the prediction of late PTB when combined with maternal characteristics.

Intervenções psicológicas necessárias: a prática como residente no serviço de medicina fetal / Necessary psychological interventions: the practice as a resident in the fetal medicine service / Intervenciones psicológicas necesarias: la práctica como residente en el servicio de medicina fetal

Com os avanços tecnológicos e o aprimoramento da prática médica via ultrassonografia, já é possível detectar possíveis problemas no feto desde a gestação. O objetivo deste estudo foi analisar a prática do psicólogo no contexto de gestações que envolvem riscos fetais. Trata-se de um estudo qualitativo sob formato de relato de experiência como psicólogo residente no Serviço de Medicina Fetal da Maternidade Escola da Universidade Federal do Rio de Janeiro (UFRJ). Os registros, feitos por observação participante e diário de campo, foram analisados em dois eixos temáticos: 1) intervenções psicológicas no trabalho em equipe em consulta de pré-natal, exame de ultrassonografia e procedimento de amniocentese; e 2) intervenções psicológicas em casos de bebês incompatíveis com a vida. Os resultados indicaram que o psicólogo nesse serviço é essencial para atuar de forma multiprofissional na assistência pré-natal para gravidezes de alto risco fetal. Ademais, a preceptoria do residente é relevante para sua formação e treinamento para atuação profissional no campo da psicologia perinatal.(AU)

Face to the technological advances and the improvement of medical practice via ultrasound, it is already possible to detect possible problems in the fetus since pregnancy. The objective of this study was to analyze the psychologist's practice in the context of pregnancies which involve fetal risks. It is a qualitative study based on an experience report as a psychologist trainee at the Fetal Medicine Service of the Maternity School of UFRJ. The records, based on the participant observation and field diary, were analyzed in two thematic axes: 1) psychological interventions in the teamwork in the prenatal attendance, ultrasound examination and amniocentesis procedure; and 2) psychological interventions in cases of babies incompatible to the life. The results indicated that the psychologist in this service is essential to work in a multidisciplinary way at the prenatal care for high fetal risk pregnancies. Furthermore, the resident's preceptorship is relevant to their education and training for professional performance in the field of Perinatal Psychology.(AU)

Con los avances tecnológicos y la mejora de la práctica médica a través de la ecografía, ya se puede detectar posibles problemas en el feto desde el embarazo. El objetivo de este estudio fue analizar la práctica del psicólogo en el contexto de embarazos de riesgos fetal. Es un estudio cualitativo basado en un relato de experiencia como residente de psicología en el Servicio de Medicina Fetal de la Escuela de Maternidad de la Universidade Federal do Rio de Janeiro (UFRJ). Los registros, realizados en la observación participante y el diario de campo, se analizaron en dos ejes temáticos: 1) intervenciones psicológicas en el trabajo en equipo, en la consulta prenatal, ecografía y los procedimientos de amniocentesis; y 2) intervenciones psicológicas en casos de bebés incompatibles con la vida. Los resultados señalaron como fundamental la presencia del psicólogo en este servicio trabajando de forma multidisciplinar en la atención prenatal en el contexto de embarazos de alto riesgo fetal. Además, la tutela del residente es relevante para su educación y formación para el desempeño profesional en el campo de la Psicología Perinatal.(AU)

The Overlooked Impact of Lower Uterine Segment Contractions on Second Trimester Cervical Assessment.

INTRODUCTION: Asymptomatic contractions in the lower uterine segment (LUS) may affect uterocervical angle and cervical length (CL); however, this has never been investigated. Therefore, the aim of this study was to evaluate the effect of LUS contractions on uterocervical angle, CL, and LUS thickness. MATERIALS AND METHODS: This was a prospective, observational, single-cohort study conducted on 102 asymptomatic singleton pregnancies between 19.0 and 22.6 weeks of gestation. Uterocervical angle and CL were measured by transvaginal ultrasound at two different time points with an interval of at least 20 min. LUS thickness was also measured as an indirect marker of myometrial contraction. A linear and curvilinear regression were performed to explore a potential association between LUS contractions, measured as increments in LUS thickness, and changes in CL and uterocervical angle. RESULTS: The linear regression between changes in LUS thickness and changes in CL showed that LUS contractions impact CL; for every 1-mm increase in LUS thickness, CL increased by 0.909 mm, when the isthmus was included in the CL measurement (R2 = 0.358; ß = 0.909; p < 0.001). By contrast, when the isthmus was not included in the measurement, a curvilinear relation between changes in LUS thickness and changes in CL was found (R2 = 0.077; ß1 = 0.575, ß2 = 0.038; p = 0.018). The relation between changes in uterocervical angle and changes in LUS thickness was not significant. DISCUSSION/CONCLUSION: LUS contractions can be observed in many asymptomatic women during the second trimester of pregnancy. LUS contractions lead to an increase in CL and LUS thickness, thus impacting ultrasound cervical assessments. These contractions do not affect the uterocervical angle.

Cost-effectiveness of cervical length screening and progesterone treatment to prevent spontaneous preterm delivery in Sweden.

OBJECTIVE: To estimate the cost-effectiveness of strategies to prevent spontaneous preterm delivery (PTD) in asymptomatic singleton pregnancies, using prevalence and healthcare cost data from the Swedish healthcare context. METHODS: We designed a decision analytic model based on the Swedish CERVIX study to estimate the cost-effectiveness of strategies to prevent spontaneous PTD in asymptomatic women with a singleton pregnancy. The model was constructed as a combined decision-tree model and Markov model with a time horizon of 100 years. Four preventive strategies, namely 'Universal screening', 'High-risk-based screening' (i.e. screening of high-risk women only), 'Low-risk-based screening' (i.e. treatment of high-risk population and screening of remaining women) and 'Nullipara screening' (i.e. treatment of high-risk population and screening of nulliparous women only), included second-trimester cervical length (CL) screening by transvaginal ultrasound followed by vaginal progesterone treatment in the case of a short cervix. A fifth preventive strategy involved vaginal progesterone treatment of women with previous spontaneous PTD or late miscarriage but no CL screening ('No screening, treat high-risk group'). For comparison, we used a sixth strategy implying no specific intervention to prevent spontaneous PTD, reflecting the current situation in Sweden ('No screening'). Probabilities for a short cervix (CL ≤ 25 mm; base-case) and for spontaneous PTD at < 33 + 0 weeks and at 33 + 0 to 36 + 6 weeks were derived from the CERVIX study, and probabilities for stillbirth, neonatal mortality and long-term morbidity (cerebral palsy) from Swedish health data registers. Costs were based on Swedish data, except costs for cerebral palsy, which were based on Danish data. We assumed that vaginal progesterone reduces spontaneous PTD before 33 weeks by 30% and spontaneous PTD at 33-36 weeks by 10% (based on the literature). All analyses were from a societal perspective. We expressed the effectiveness of each strategy as gained quality-adjusted life years (QALYs) and presented cost-effectiveness as average (ACER; average cost per gained QALY compared with 'No screening') and incremental (ICER; difference in costs divided by the difference in QALYs for each of two strategies being compared) cost-effectiveness ratios. We performed deterministic and probabilistic sensitivity analysis. The results of the latter are shown as cost-effectiveness acceptability curves. Willingness-to-pay was set at a maximum of 500 000 Swedish krona (56 000 US dollars (USD)), as suggested by the Swedish National Board of Health and Welfare. RESULTS: All interventions had better health outcomes than did 'No screening', with fewer screening-year deaths and more lifetime QALYs. The best strategy in terms of improved health outcomes was 'Low-risk-based screening', irrespective of whether screening was performed at 18 + 0 to 20 + 6 weeks (Cx1) or at 21 + 0 to 23 + 6 weeks (Cx2). 'Low-risk-based screening' at Cx1 was cost-effective, while 'Low-risk-based screening' at Cx2 entailed high costs compared with other alternatives. The ACERs were 2200 USD for 'Low-risk-based screening' at Cx1 and 36 800 USD for 'Low-risk-based screening' at Cx2. Cost-effectiveness was particularly sensitive to progesterone effectiveness and to productivity loss due to sick leave during pregnancy. The probability that 'Low-risk-based screening' at Cx1 is cost-effective compared with 'No screening' was 71%. CONCLUSION: Interventions to prevent spontaneous PTD in asymptomatic women with a singleton pregnancy, including CL screening with progesterone treatment of cases with a short cervix, may be cost-effective in Sweden. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Personalized assessment of cervical length improves prediction of spontaneous preterm birth: a standard and a percentile calculator.

BACKGROUND: A sonographic short cervix (length <25 mm during midgestation) is the most powerful predictor of preterm birth. Current clinical practice assumes that the same cervical length cutoff value should apply to all women when screening for spontaneous preterm birth, yet this approach may be suboptimal. OBJECTIVE: This study aimed to (1) create a customized cervical length standard that considers relevant maternal characteristics and gestational age at sonographic examination and (2) assess whether the customization of cervical length evaluation improves the prediction of spontaneous preterm birth. STUDY DESIGN: This retrospective analysis comprises a cohort of 7826 pregnant women enrolled in a longitudinal protocol between January 2006 and April 2017 at the Detroit Medical Center. Study participants met the following inclusion criteria: singleton pregnancy, ≥1 transvaginal sonographic measurements of the cervix, delivery after 20 weeks of gestation, and available relevant demographics and obstetrical history information. Data from women without a history of preterm birth or cervical surgery who delivered at term without progesterone treatment (N=5188) were used to create a customized standard of cervical length. The prediction of the primary outcome, spontaneous preterm birth at <37 weeks of gestation, was assessed in a subset of pregnancies (N=7336) that excluded cases with induced labor before 37 weeks of gestation. Area under the receiver operating characteristic curve and sensitivity at a fixed false-positive rate were calculated for screening at 20 to 23 6/7, 24 to 27 6/7, 28 to 31 6/7, and 32 to 35 6/7 weeks of gestation in asymptomatic patients. Survival analysis was used to determine which method is better at predicting imminent delivery among symptomatic women. RESULTS: The median cervical length remained fundamentally unchanged until 20 weeks of gestation and subsequently decreased nonlinearly with advancing gestational age among women who delivered at term. The effects of parity and maternal weight and height on the cervical length were dependent on the gestational age at ultrasound examination (interaction, P<.05 for all). Parous women had a longer cervix than nulliparous women, and the difference increased with advancing gestation after adjusting for maternal weight and height. Similarly, maternal weight was nonlinearly associated with a longer cervix, and the effect was greater later in gestation. The sensitivity at a 10% false-positive rate for prediction of spontaneous preterm birth at <37 weeks of gestation by a short cervix ranged from 29% to 40% throughout pregnancy, yet it increased to 50%, 50%, 53%, and 54% at 20 to 23 6/7, 24 to 27 6/7, 28 to 31 6/7, and 32 to 35 6/7 weeks of gestation, respectively, for a low, customized percentile (McNemar test, P<.001 for all). When a cervical length <25 mm was compared to the customized screening at 20 to 23 6/7 weeks of gestation by using a customized percentile cutoff value that ensured the same negative likelihood ratio for both screening methods, the customized approach had a significantly higher (about double) positive likelihood ratio in predicting spontaneous preterm birth at <33, <34, <35, <36, and <37 weeks of gestation. Among symptomatic women, the difference in survival between women with a customized cervical length percentile of ≥10th and those with a customized cervical length percentile of <10th was greater than the difference in survival between women with a cervical length ≥25 mm and those with a cervical length <25 mm. CONCLUSION: Compared to the use of a cervical length <25 mm, a customized cervical length assessment (1) identifies more women at risk of spontaneous preterm birth and (2) improves the distinction between patients at risk for impending preterm birth in those who have an episode of preterm labor.

Sonoelastographic Assessment of the Uterine Cervix in the Prediction of Imminent Delivery in Singleton Nulliparous Women Near Term: A Prospective Cohort Study.

OBJECTIVES: To explore the role of newly developed software to assess cervical sonoelastography in predicting the onset of spontaneous delivery in singleton pregnancies at term and to compare its diagnostic performance with that provided by the cervical length (CL) and posterior cervical angle (PCA). METHODS: This work was a prospective study including nulliparous singleton pregnancies at gestational ages of 37 weeks to 38 weeks 6 days. The CL, PCA, hardness ratio (HR), and mean strain from the internal os and external os were obtained by a transvaginal ultrasound approach using semiautomatic software (E-Cervix; Samsung Medison Co, Ltd, Seoul, Korea). Multivariate logistic regression and area under the curve analyses were used to test the strength of the association and the diagnostic performance of the variables considered in predicting delivery within 7 days. RESULTS: A total of 398 women were included, and 24.6% delivered within 7 days. The CL was shorter (19.5 versus 2 7 mm; P = .0001), PCA narrower (99° versus 102°; P = .02) HR lower (35.3 versus 40.7; P = .0001), mean strain from the external os higher (0.41 versus 0.35; P = .0001), and mean strain from the internal os higher (0.38 versus 0.33; P = .0001) higher in women who delivered within 7 days from the assessment. At the multivariable logistic regression analysis, the CL (adjusted odds ratio, 1.307) and HR (adjusted odds ratio, 1.227) were the only variables independently associated with delivery within 1 week. A model combining the CL and HR showed an area under the curve of 0.873 in predicting delivery within 7 days, higher than that obtained by using the CL and HR singularly (P ≤ .0001). CONCLUSIONS: The HR assessed by sonoelastography improves the efficacy of the CL in predicting imminent delivery in nulliparous women close to term.

Guideline No. 401: Sonographic Cervical Length in Singleton Pregnancies: Techniques and Clinical Applications.

OBJECTIVES: • To assess the association between sonography-derived cervical length measurement and preterm birth. • To describe the various techniques to measure cervical length using sonography. • To review the natural history of the short cervix. • To review the clinical uses, predictive ability, and utility of sonography-measured short cervix. OUTCOMES: Reduction in rates of prematurity and/or better identification of those at risk, as well as possible prevention of unnecessary interventions. INTENDED USERS: Clinicians involved in the obstetrical management or cervical imaging of patients at increased risk of a short cervix. TARGET POPULATION: Women at increased risk of a short cervix or at risk of preterm birth. EVIDENCE: Literature published up to June 2019 was retrieved through searches of PubMed and the Cochrane Library using appropriate controlled vocabulary and key words (preterm labour, ultrasound, cervix, cervical insufficiency, transvaginal, transperineal, cervical length, fibronectin). Results were restricted to general and systematic reviews, randomized controlled trials, controlled clinical trials, and observational studies. There were no date or language restrictions. Grey (unpublished) literature was identified through searching the websites of health technology assessment agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The evidence and this guideline were reviewed by the Diagnostic Imaging Committee of the Society of Obstetricians and Gynaecologists of Canada, and the recommendations were made and graded according to the rankings of the Canadian Task Force on Preventive Health Care (Online Appendix Table A1). BENEFITS, HARMS, COSTS: Preterm birth is a leading cause of perinatal morbidity and mortality. Use of the sonographic technique reviewed in this guideline may help identify women at risk of preterm birth and, in some circumstances, lead to interventions that may reduce the rate of preterm birth. SUMMARY STATEMENTS (CANADIAN TASK FORCE ON PREVENTIVE HEALTH CARE GRADING IN PARENTHESES): RECOMMENDATIONS (CANADIAN TASK FORCE ON PREVENTIVE HEALTH CARE GRADING IN PARENTHESES).

Progesterone and preterm birth.

Progestogens (vaginal progesterone and intramuscular 17-hydroxyprogesterone acetate) are widely recommended for women at high risk of preterm birth. Typical regimens include 17-hydroxyprogesterone caproate (250 mg intramuscularly weekly), starting at 16-20 gestational weeks until 36 weeks or delivery for women with a singleton gestation and a history of spontaneous preterm birth, or vaginal progesterone (90-mg vaginal gel or 200-mg micronized vaginal soft capsules) for women with a short cervix (typically ≤25 mm). Although some randomized trials support this approach, neither of the largest trials (PROLONG for 17-hydroxyprogesterone acetate or OPPTIMUM for vaginal progesterone) demonstrated efficacy. There are almost no data on long-term effects, and none that shows benefit beyond the neonatal period. Although some analyses suggest the cost-effectiveness of the approach, a cervical length screening program followed by progesterone for those with a short cervix will reduce preterm birth rates by less than 0.5%. The present review assesses evidence on the efficacy, likely impact, and long-term effects of implementing the recommendations for progestogens in full. Clinicians and pregnant women can look forward to resolution of the conflicting views on efficacy once the Patient-Centered Outcomes Research Initiative (PCORI)-funded individual patient data meta-analysis is published.

Assessment of the cervix in pregnant women with a history of cervical insufficiency during the first trimester using elastography.

INTRODUCTION: To investigate changes in first trimester cervical elastography, cervical length and endocervical canal width in pregnant women with a history of cervical insufficiency, and further discuss the possibility of using these markers as predictors of cervical insufficiency in early pregnancy. MATERIAL AND METHODS: This was an observational ultrasound study of first trimester cervical changes in singleton pregnancies between January 2016 and June 2018. Cervical elastography, cervical length and endocervical canal width were measured during the first trimester. Strain elastography was used to estimate the softness of anterior and posterior cervical lips and was expressed as percentages (strain rate). RESULTS: Of the 339 pregnant women enrolled, 24 had a history of cervical insufficiency. The anterior cervical lip was significantly softer in the cervical insufficiency group (strain rate: 0.19% ± 0.05% vs 0.11% ± 0.04%; P < .001). Cervical length was significantly shorter in the cervical insufficiency group (36.3 ± 4.8 mm vs 38.3 ± 3.8 mm; P = .014). Endocervical canal width was significantly wider in the cervical insufficiency group (5.7 ± 1.1 mm vs 5.2 ± 0.7 mm; P = .001). Receiver operating characteristic curve analyses revealed that the optimal cut-off values of anterior cervical lip, cervical length and endocervical canal width to confirm the diagnosis of cervical insufficiency were 0.15%, 35.5 mm and 5.75 mm, respectively. In multivariate logistic regression analysis, significant differences were still observed in anterior cervical strain rate (adjusted odds ratio [OR] 53.78, 95% [confidence interval [CI] 11-270; P < .001) and endocervical canal width (adjusted OR, 5.41, 95% CI,1.2-24.7; P = .029). CONCLUSIONS: First trimester cervical elastography is a valuable tool in the assessment of women with a history of cervical insufficiency. The anterior cervical lip was significantly softer in women with a history of cervical insufficiency, and the sensitivity and specificity of anterior cervical lip strain were better than that of cervical length and endocervical canal width.

Shear-wave sonoelastographic assessment of cervix in pregnancy.

INTRODUCTION: The aim of this study was to investigate the differences in shear-wave sonoelastography (SWS) scores between the different parts of cervix, explore the association between the cervical SWS scores with cervical length and evaluate repeatability of the measurement of cervical SWS scores. MATERIAL AND METHODS: This was a prospective study performed in women with singleton pregnancy at 11-13+6 (n = 676), 16-20+6 (n = 364), 21-24+6 (n = 338) and 28-32+6 weeks (n = 304). The SWS scores were obtained at the inner, middle and external parts of the cervix, using a transvaginal ultrasound approach. RESULTS: The SWS scores of the inner cervix were significantly higher than the measurements acquired at the middle and external parts (all P < .001). At 21-24+6 and 28-32+6 weeks, most regions of interest demonstrated a very weak positive correlation with cervical length (r = .125 to r = .299). In comparison with nulliparous women, parous women without prior preterm birth had higher SWS scores of the inner and middle parts of the cervix at 16-20+6 and 21-24+6 weeks. All regions of interest showed good intra- and inter-observer agreement. CONCLUSIONS: The assessment of the cervical SWS scores is highly reproducible. The stiffness of the cervix demonstrates a gradient that decreases from the inner part to the external part and a very weak positive correlation with cervical length.

Universal cervical length screening with a cervicometer to prevent preterm birth <34 weeks: a decision and economic analysis.

Background: Preterm birth is a leading cause of neonatal morbidity and mortality worldwide; evidence-based strategies to decrease preterm birth are desperately needed.Objective: The purpose of this study was to estimate which of three strategies for screening for shortened cervix in asymptomatic low-risk women is the most cost-effective in terms of prevention of preterm birth and associated morbidity.Study design: A decision analysis model was developed from available published evidence comparing three strategies in screening asymptomatic low-risk women for shortened cervix: (1) cervicometer with subsequent referral for transvaginal ultrasound, (2) transvaginal ultrasound screening, and (3) no screening. The cost and effectiveness of each strategy was assessed in terms of quality-adjusted life-years (QALYs), and cost in US dollars.Results: Screening with a cervicometer with referral was the most cost-effective strategy and represented a savings of $999.65 ($11,617.28 versus $12,616.93) over screening with ultrasound, and a savings of $15,601.62 ($11,617.28 versus $27,218.90) over no screening. Costs for outcomes ranged from $3528 for a healthy neonate ≥34 weeks to $717,467.5 for a neonate <34 weeks with severe morbidity. The cervicometer strategy avoided 11.68 neonatal deaths per 1000 deliveries (3.59 deaths versus 15.27 deaths) compared with no screening, and avoided 0.73 neonatal deaths per 1000 deliveries (3.59 deaths versus 4.32 deaths) compared with ultrasound strategy. The cervicometer strategy prevented 82.44 preterm births per 1000 deliveries (22.56 versus 105.00) compared with no screening, and 5.10 preterm births per 1000 deliveries (22.56 versus 27.66) compared with ultrasound strategy. Per QALY, cervicometer screening cost $386.57, transvaginal ultrasound cost $420.31, and no screening cost $922.73. Sensitivity analyses confirmed the robustness of these findings, including evaluation across the range of quoted transvaginal ultrasound costs ($43-$300).Conclusion: A simulation of universal screening of asymptomatic low-risk women with a cervicometer with subsequent referral for ultrasound for those with a cervix <25 mm is cost-effective and yields the greatest reduction in preterm births at <34 weeks. A risk simulation trial noted that a cervicometer strategy may be more expensive than a universal transvaginal ultrasound strategy, but both are less expensive than a no screening strategy.

Correlation of transabdominal and transvaginal sonography for the assessment of uterocervical angle at 16-24 weeks' gestation.

The objective of this study was to determine the correlation between transabdominal (TAS) and transvaginal sonography (TVS) uterocervical angle (UCA) measurement in pregnant women with no history of previous preterm birth. A cross-sectional study involving singleton pregnancies between 16 and 24 weeks of gestation who underwent routine foetal anatomical scan was conducted. The TAS-UCA measurement was performed before voiding and with an empty bladder. A total of 256 women completed the sonography. The mean maternal age was 32 ± 6.68 years. The mean gestation age at the time of ultrasound assessment was 19 ± 1.71 weeks. The mean prevoid TAS-UCA was 119.74 ± 33.12° and the mean postvoid TAS-UCA was 110.73 ± 25.30°. There was a significant difference between prevoid and postvoid TAS-UCA measurement (p < .05). The mean TVS-UCA was 103.91 ± 26.42°. The Pearson correlation coefficients of prevoid and postvoid TAS-UCA with TVS-UCA were 0.438 and 0.601, respectively. In conclusion, the postvoid TAS-UCA has moderate correlation with TVS-UCA measurement and is better than the prevoid TAS-UCA in women with low risk for preterm birth.IMPACT STATEMENTWhat is already known on this subject? TVS is the gold standard for cervical length (CL) assessment for prediction preterm birth. However, TVS requires an experienced or trained sonographer and some women decline TVS because of the embarrassment and discomfort during examination. Several studies have demonstrated the correlation between TAS and TVS and suggested that TAS could be an alternative for CL screening. UCA has been reported as a new predictor of spontaneous preterm birth and is usually performed by TVS. Thus, it is interesting to evaluate whether TAS can be a substitute procedure for TVS in UCA measurement.What the results of this study add? TAS may be used as a substitute procedure for TVS and the postvoid TAS is more appropriate than prevoid TAS for UCA measurement.What the implications are of these findings for clinical practice and/or further research? TAS may be an alternative method for UCA measurement when TVS is unavailable or in pregnant women who decline TVS-UCA measurement. However, further study should be conducted to confirm the association between TVS-UCA and postvoid TAS-UCA before deciding to use postvoid TAS-UCA as a screening tool for preterm prediction.

Cervical pessary vs vaginal progesterone for prevention of preterm birth in women with twin pregnancy and short cervix: economic analysis following randomized controlled trial.

OBJECTIVE: To compare the cost-effectiveness of cervical pessary vs vaginal progesterone to prevent preterm birth and neonatal morbidity in women with twin pregnancy and a short cervix. METHODS: Between 4 March 2016 and 3 June 2017, we performed this economic analysis following a randomized controlled trial (RCT), performed at My Duc Hospital, Ho Chi Minh City, Vietnam, that compared cervical pessary to vaginal progesterone in women with twin pregnancy and cervical length < 38 mm between 16 and 22 weeks of gestation. We used morbidity-free neonatal survival as a measure of effectiveness. Data on pregnancy outcome, maternal morbidity and neonatal complications were collected prospectively from medical files; additional information was obtained via telephone interviews with the patients. The incremental cost-effectiveness ratio was calculated as the incremental cost required to achieve one extra surviving morbidity-free neonate in the pessary group compared with in the progesterone group. Probabilistic and one-way sensitivity analyses were also performed. RESULTS: During the study period, we screened 1113 women with twin pregnancy, of whom 300 fulfilled the inclusion criteria of the RCT and gave informed consent to participate. These women were assigned randomly to receive cervical pessary (n = 150) or vaginal progesterone (n = 150), with two women and one woman, respectively, being lost to follow-up. The rate of morbidity-free neonatal survival was significantly higher in the pessary group compared with the progesterone group (n = 241/296 (81.4%) vs 219/298 (73.5%); relative risk, 1.11 (95% CI, 1.02-1.21), P = 0.02). The mean total cost per woman was 3146 € in the pessary group vs 3570 € in the progesterone group (absolute difference, -424 € (95% CI, -842 to -3 €), P = 0.048). The cost per morbidity-free neonate was significantly lower in the pessary group compared with that in the progesterone group (2492 vs 2639 €; absolute difference, -147 € (95% CI, -284 to 10 €), P = 0.035). CONCLUSION: In women with twin pregnancy and a short cervix, cervical pessary improves significantly the rate of morbidity-free neonatal survival while reducing costs, as compared with vaginal progesterone. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.