External validation of prognostic models predicting pre-eclampsia: individual participant data meta-analysis.

BACKGROUND: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-eclampsia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-eclampsia using individual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. METHODS: IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-eclampsia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-eclampsia as an outcome were included for validation. We reported the model predictive performance as discrimination (C-statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. RESULTS: Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C-statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model's calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. CONCLUSIONS: The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-eclampsia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice. TRIAL REGISTRATION: PROSPERO ID: CRD42015029349 .

Early fetal ultrasound screening for major congenital heart defects without Doppler.

OBJECTIVE: Congenital heart defects are the most common major structural fetal abnormalities. Color flow mapping has played a dominant role in the detection of abnormalities during the first trimester, regardless of the International Society of Ultrasound in Obstetrics and Gynecology warning on the use of Doppler during early pregnancy. The aim of our study was to investigate the use of transvaginal two-dimensional sonography without Doppler for assessing the four-chamber view and the outflow tract view of fetuses at 11-13 weeks of gestation for cardiac screening of major congenital heart defects. STUDY DESIGN: This was a prospective observational study conducted in the Fetal Medicine Unit of Cabueñes University Hospital, between May 2014 and August 2015. Only low risk-pregnancies were studied. All ultrasonographic examinations were performed by two experienced sonographers in maternal-fetal medicine. The combination of high-frequency transvaginal (nine MHz) and transabdominal (six MHz) ultrasonography transducers were used. An early cardiac screening was performed in 97% of cases. Statistical analysis was carried out using successive multivariate logistic regression models in order to investigate the effect of crown-rump length and body mass index on the probability of visualizing the four-chamber view and/or the outflow tract view. RESULTS: 663 low-risk pregnant women were included. Regarding the transvaginal approach, neither the crown-rump length nor the body mass index had a statistically significant relationship on the probability of visualization of the four-chamber view and outflow tract view. For the transabdominal approach, the crown-rump length and the body mass index presented a statistically significant effect on the visualization of the four-chamber view and the outflow tract view. Using the transvaginal approach: the success rate of performing a four-chamber view was 89.4% and 82.4% for the outflow tract view. Using the transabdominal approach: the success rate of performing a four-chamber view was 77.8% and 61.5% for the outflow tract view. Four major congenital heart defects were diagnosed, and the prenatal ultrasonagraphic diagnosis was confirmed for all cases. CONCLUSIONS: Routine first-trimester ultrasonagraphy without Doppler, when performed by experienced sonographers, can effectively identify major congenital heart defects. Additional multicenter well designed studies should clarify the feasibility of this approach.

Evaluación del seguimiento de embarazo de bajo riesgo en el Área Sanitaria V del Principado de Asturias / Low risk pregnancy control in the Health Area V-Asturias

Objetivo: Analizar el nivel de eficiencia del cambio en el protocolo de seguimiento de embarazo de bajo riesgo, desarrollado e implantado en atención primaria y atención hospitalizada. Metodología: Se calcula el coste económico teórico y real del seguimiento del embarazo de bajo riesgo desde febrero hasta julio de los años 2016 y 2017. Se comparan ambos costes y se calcula el ahorro teórico y real. El nuevo protocolo supone principalmente un cambio en la distribución de visitas entre el hospital, realizadas por obstetras, y la atención primaria, realizadas por matronas. La evaluación se hace en función del ahorro económico teórico previsto por la implantación del protocolo y el ahorro real generado durante el periodo de febrero-julio de 2017, según las tarifas de consultas publicadas en el Boletín Oficial del Principado de Asturias. Resultados: Disminución de un 75% de las consultas en el hospital antes de la semana 37 de gestación y un aumento del 100% en atención primaria. Dado el número de embarazos desde febrero hasta julio de los años 2016 y 2017, el ahorro teórico estimado es de 175.456,4 Euros, y el ahorro real de 20.007,2 Euros. Discusión: El análisis entre la situación teórica y la real muestra un alto número de consultas en atención primaria, una disminución menor de la esperada en las consultas de atención especializada y un inexplicable aumento de las consultas de embarazo de alto riesgo. Conclusiones: Es preciso realizar una revaluación una vez pasado el periodo de implantación, reconducir a atención primaria los controles de embarazo de bajo riesgo que siguen realizándose en el hospital, revisar el registro de visitas en atención primaria y evaluar el aumento de las consultas de embarazo de alto riesgo

Objective: The objective of this work is to analyze the efficiency level of the change in the protocol of low risk pregnancy, monitored, developed and implanted in primary care and hospitalized care. Methodology: The theoretical and real economic costs of monitoring low-risk pregnancy from February to July of 2016 and 2017 are calculated. Then, both costs are compared and finally, the theoretical and real savings are calculated. Mainly, the new protocol involves a change in the distribution of visits between hospitals made by obstetricians, and primary care, performed by midwives. The evaluation is based on the theoretical economic savings foreseen by the implementation of the protocol and the real savings generated during the period of February-July 2017, according to the consultation rates published in the Official Gazette of the Principado of Asturias. Results: Reduction of 75% of consultations in hospital before week 37 and a 100% increase in primary. Given the number of pregnancies of the period February-July 2016 and 2017, the estimated theoretical saving is 175.456.4 Euros and the real saving is 20.007.2 Euros. Discussion: The analysis between the theoretical situation and the real one reveals a high number of consultations in primary care, a smaller decrease, than expected, in specialized care consultations and an inexplicable increase in high risk pregnancy consultations. Conclusions: It is precise reassessment once the implementation period has passed, redirect to primary care those low risk pregnancy controls that continue to be performed in the hospital, review the registry of visits in primary care, and evaluate the increase in high-risk pregnancy consultations

Malformación cloacal: a propósito de un caso / Cloacal malformation: on the subject of a case

Objetivo: descripción de hallazgos básicos para establecer sospecha de malformación cloacal. Material y métodos: estudio descriptivo de caso único de malformación cloacal, sospechado tras repetición de ecografía de primer trimestre por traslucencia nucal > p-99, con sacos linfáticos yugulares bilaterales y cribado combinado de 1/968. Resultados: presentamos el caso de una gestante cuya sospecha se estableció en la semana 15 de gestación mediante control ecográfico seriado y con diagnóstico anatomo-patológico definitivo tras estudio necrópsico al realizar interrupción legal del embarazo. Conclusiones: hemos sospechado esta rara y severa entidad precozmente mediante signos indirectos que induce a un examen exhaustivo. De esta manera, es posible llegar a su diagnóstico definitivo y clasificar su severidad, futuro pronóstico y posible tratamiento (AU)

Objective: Description of basic findings to be able to suspect cloacal malformation. Material and methods: Descriptive study of a unique case of cloacal malformation, suspected in a repeated ultrasound of the first trimester because of a nucal translucency of > p-99, with bilateral yugular saccules and combined risk 1/968. Results: We report the case of a pregnant woman, in which we suspected this malformation during de 15th week of gestation with repeated ultrasound, and with a definitive anatomy- pathological diagnosis as she performed a legal interruption of de gestation. Conclusion: We have suspected this strange and severe entity in a early time because of indirect signs that obligated us to an exhaustive exam. In this way, it is possible to establish a definitive diagnose and severity, future prognosis and treatment possibilities (AU)

Detección y manejo de las alteraciones del crecimiento fetal en España. Encuesta nacional / Detection and management of fetal growth disorders in Spain. National survey

Objetivo: conocer la situación actual a nivel nacional sobre diferentes cuestiones relacionadas con el crecimiento intrauterino restringido, específicamente sobre tablas de referencia para el cálculo y asignación de percentil, programas de cribado o protocolos de diagnóstico, de manejo, etc. Material y métodos: se realizó una encuesta consensuada entre SESEGO y SEMEPE, avalada por SEGO y publicada en su web oficial durante cuatro meses en el año 2015. Fue posible analizar el total de los 171 formularios que representan a todas las Comunidades y 41 provincias de España. A la vista del perfil de la encuesta podemos establecer que refleja la manera de actuar de los hospitales grandes y docentes (80% con más de 1.000 partos/ año, 85% con 11 o más especialistas de plantilla y 77% con docencia MIR) del sistema público (91%) de todo el territorio nacional (82%). Resultados: permiten reconocer una amplia variabilidad en la práctica clínica en cuestiones tan fundamentales como las tablas de peso fetal a utilizar, la asignación del percentil para la evaluación del crecimiento fetal, las tablas de referencia para los índices Doppler, la realización o no de un cribado poblacional, cómo y a qué edad gestacional debería programarse, o qué tipo de intervenciones pueden optimizar el pronóstico materno y fetal. Conclusiones: parece ineludible y prioritario que debemos aceptar como un reto la unificación de criterios y recomendaciones en este campo. Los encuestados se pronuncian de manera contundente e inequívoca con que este papel debe ser asumido y liderado por nuestras Sociedades Científicas: SEGO, SESEGO, SEMEPE, etc (AU)

Objective: Knowing the current situation at the national level on different issues related to fetal growth restriction; specifically reference tables for percentile calculation and allocation, screening programs or diagnostic and management protocols. Material and methods: A Consensus Survey was conducted between SESEGO and SEMEPE, endorsed by SEGO and published on its official website for four months in 2015. It was possible to analyze the total of 171 forms representing all Communities and 41 provinces of Spain. In terms of the profile of the survey, we can establish that it reflects the behavior of large and teaching hospitals (80% with more than 1000 births/year, 85% with 11 or more specialists and 77% with MIR teaching). Hospitals belong to public system (91%) of the whole national territory (82%). Results: The survey allows the recognition of a wide variability in the clinical practice in matters as fundamental as the tables of fetal weight to be used, the allocation of the percentile for the evaluation of the fetal growth, the reference tables for the Doppler indices, the realization or not of a population growth restriction screening. How and at what gestational age should be programmed that screening or what types of interventions can optimize maternal and fetal prognosis. Conclusions: It seems inevitable and a priority that we must accept as a challenge the unification of criteria and recommendations in this field. Responders pronounce in a forceful and unequivocal manner that this role must be assumed and led by our Scientific Societies: SEGO, SESEGO, SEMEPE, etc (AU)

Abdomen agudo secundario a malformación congénita del mesenterio / Acute abdomen secondary to congenital malformation of the mesentery

Presentamos el caso de una primigesta de 19 semanas que comienza con un cuadro obstructivo intestinal secundario a una malformación congénita del mesenterio, que se complica con estrangulación, perforación y peritonitis fecaloidea. La evaluación de una embarazada con dolor abdominal debe ser llevada a cabo de manera rápida y eficaz. El abdomen agudo puede ser el resultado de causas gastrointestinales, ginecológicas, urológicas y obstétricas. El retraso en el diagnóstico y en la intervención quirúrgica solo empeora el resultado para la madre y el feto (AU)

We report the case of a primigravida at 19 weeks of pregnancy who presented with intestinal obstruction secondary to congenital malformation of the mesentery complicated by strangulation, perforation and fecal peritonitis. Pregnant women with abdominal pain must be evaluated quickly and efficiently. An acute abdomen may be the result of gastrointestinal, gynecological, urological or obstetric causes. Delay in diagnosis and surgical intervention only worsens the outcome for the mother and fetus (AU)

Cribado combinado de síndrome de Down en primer trimestre: comparación de resultados de 4 años de aplicación con los 4 años precedentes / First-trimester combined screening for Down syndrome: comparison of the 4-year results with the previous 4 years

Objetivo. Analizar los resultados de 4 años de aplicación del programa de cribado combinado del primer trimestre y su impacto sobre las tasas de detección de síndrome de Down, cobertura poblacional y procedimientos invasivos. Sujetos y métodos. Estudio retrospectivo poblacional de 8 años consecutivos (17.564 gestaciones que contienen 51 síndromes de Down), en 2 periodos: 31 de enero de 2002 a 30 de enero de 2006, sin cribado (8.182 gestaciones y 24 síndromes de Down) y 31 de enero de 2006 a 30 de enero de 2010, con cribado (8.382 gestaciones y 27 síndromes de Down). El cribado se aplicó en 2 fases: bioquímica a la 10 semana y ecografía a la 12 semana. Se comparan los resultados del cribado con los del periodo precedente basado en la edad materna y la medida de la translucencia nucal. Resultados. La cobertura poblacional fue de 93%. La tasa de detección de síndrome de Down por aplicación del cribado combinado ha sido del 89% (91% para feto único) para un 3,5% de falsos positivos y se realizaron 824 procedimientos invasivos (34,3 para 1 diagnóstico). En los 4 años previos a la aplicación del cribado, la tasa de detección era del 71% y se realizaron 1.406 procedimientos invasivos (87,8 para un diagnóstico). Conclusión. El cribado combinado ha mejorado las tasas de detección para síndrome de Down en un 18%, al tiempo que ha permitido reducir en un 41% los procedimientos invasivos (AU)

Objective. To analyze the 4-year results of first-trimester combined screening and its impact on rates of Down syndrome detection, population coverage and invasive procedures. Subjects and methods. We performed a retrospective population-based study over 8 consecutive years (17,564 gestations with 51 cases of Down syndrome) divided in two periods: from January 31, 2002 to January 30, 2006 without combined screening (8,182 gestations and 24 cases of Down syndrome) and from January 31, 2006 to January 30, 2010 with combined screening (8,382 gestations and 27 cases of Down syndrome). Combined screening was applied in two phases: biochemical analysis was performed in the 10th week of pregnancy and ultrasound examination in the 12th week. We compared the results of screening with the previous period based on maternal age and fetal nuchal translucency measurement. Results. Population coverage was 93%. The rate of Down syndrome detection due to the application of combined screening was 89% (91% for a single fetus) with a false-positive rate of 3.5%. There were 824 invasive procedures (34.1 to diagnose one episode). During the 4 years prior to the application of combined screening, the detection rate was 71% with 1,406 invasive procedures (87.8 to diagnose one episode). Conclusion. Combined screening has improved the Down syndrome detection rate by 18% and has reduced the use of invasive procedures by 41% (AU)