First-Trimester Sequential Screening for Preeclampsia Using Angiogenic Factors: Study Protocol for a Prospective, Multicenter, Real Clinical Setting Study.

Introduction: The incidence of preeclampsia (PE) is about 2-8%, making it one of the leading causes of perinatal morbidity and maternal mortality in the world. Early prophylactic low dose administration (150 mg) of acetylsalicylic acid is associated with a significant reduction in the incidence of early-onset PE, intrauterine growth restriction (IUGR), and neonatal mean stay in the intensive care unit (ICU). Universal implementation of a first-trimester screening system including angiogenic and antiangiogenic markers [the Placental Growth Factor (PlGF) and/or soluble fms-like Tyrosine Kinase-1 (sFlt-1)] has shown a prediction rate of 90% for early-onset PE but entails a high financial cost. The aim of this study is to determine the predictive and preventive capacity of a universal PE first-trimester two-step sequential screening model, determining the PlGF only in patients previously classified as intermediate risk by means of a multivariate model based on resources already used in the standard pregnancy control, in a real clinical setting. We hypothesize that this screening model will achieve similar diagnostic performance as the universal determination of PlGF but at a lower economic cost. Methods and Analysis: This is a prospective, multicentric, cohort study in a real-world clinical setting. Every singleton pregnancy will be recruited at the routine first pregnancy visit. In a first step, the first-trimester risk of PE will be calculated using a multivariate Gaussian distribution model, based on medical history, mean blood pressure, Pregnancy-Associated Plasma Protein A (PAPP-A), and Uterine Artery Doppler Pulsatility Index (UTPI). Patients will be classified into three risk groups for PE: (1) risk ≥ 1/50, high-risk with no further testing (blinded PlGF); (2) risk between 1/51 and 1/500, medium-risk requiring further testing; and (3) risk ≤ 1/501, low-risk with no further testing. In a second step, the PlGF will only be determined in those patients classified as intermediate risk after this first step, and then reclassified into high- or low-risk groups. Prophylactic administration of aspirin (150 mg/day) will be prescribed only in high risk patients. As a secondary objective, sFlt-1 values will be blindly determined in patients with high and intermediate risk to assess its potential performance in the screening for PE. Ethics and Dissemination: The study will be conducted in accordance with the principles of Good Clinical Practice. This study is approved by the Aragon Research Ethics Committee (CEICA) on 3 July 2020 (15/2020). Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04767438.

Patient opinion of analgesia during external cephalic version at term in singleton pregnancy.

To assess the opinion and the level of satisfaction of patients concerning analgesia during external cephalic version (ECV), we present the results of a survey of 120 women undergoing ECV at term during a randomised controlled trial (July 2012 to February 2013) comparing remifentanil and nitrous oxide. Overall, 110 (91.7%) women said they would repeat the procedure and 111 (92.5%) that they would recommend it to another pregnant woman, with no significant differences by type of analgesia. The administration and sense of comfort were rated better in the remifentanil group (p < .01). In conclusion, the use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women.Impact statementWhat is already known on this subject? ECV is commonly a painful manoeuvre for the woman. This pain triggers maternal reactive abdominal muscle contraction and involuntary abdominal tensing, reducing the likelihood of successful version and causing some women to reject the technique.What do the results of this study add? The use of analgesia during ECV is associated with a high rate of willingness among women to repeat the procedure and recommend it to other pregnant women. The sense of comfort during ECV was also significantly better in the remifentanil group, probably because of its greater analgesic power and greater comfort during its administration.What are the implications of these findings for clinical practice and/or further research? ECV should be carried out under analgesia, when available, not only to decrease pain but also to encourage wider adoption of the technique and enable more women to benefit from it.

Neuropatía relacionada con la cirugía bariátrica / Acute neuropathy after gastric reduction surgery

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Induction of labor in breech presentation at term: a retrospective cohort study.

OBJECTIVE: To compare the outcome of two methods of labor induction and spontaneous onset of labor in breech presentation at term. MATERIAL: A retrospective study between 2003 and 2012. We compare obstetric (indication of induction, Bishop score, cesarean rate) and perinatal outcomes (Apgar score, umbilical artery pH, base excess ≤-12 mmol/L, admission to neonatal unit) between prostaglandins and oxytocin. We also compare labor induction versus spontaneous onset of labor. RESULTS: Of the 1684 breech deliveries, we carried out labor induction in 221 cases (76% with prostaglandins, 24% with oxytocin). The prostaglandins group had significantly lower Bishop scores and the time for induction phase was significantly higher. There were no differences in cesarean rate between both methods of induction or spontaneous onset of labor. The prostaglandins group had higher rates of base excess ≤-12 mmol/L. Compared with spontaneous onset of labor in breech presentation, induction had significant lower rates of newborn weight and higher rates of admission to the neonatal unit. CONCLUSIONS: Induction of labor in breech presentation at term is a reasonable and effective option after a careful selection of cases. It was not associated with an increase of perinatal morbidity or cesarean rate compared with spontaneous onset of labor.

[Not Available]. / Ingesta dietética de pacientes adultos con esofagitis eosinofílica que siguen una dieta de exclusión de seis grupos de alimentos.

Introducción: la esofagitis eosinofílica (EEo) es una enfermedad inmunoalérgica crónica emergente en adultos. Surge como respuesta disfuncional frente a los antígenos de los alimentos y se caracteriza por síntomas recurrentes de disfunción esofágica e inflamación. El tratamiento farmacológico y dietético se basa en su patogénesis y debe ser individualizado. Uno de los posibles abordajes dietéticos se basa en la eliminación empírica de alimentos que con mayor frecuencia causan EEo.Objetivo: evaluar la ingesta dietética de los pacientes con EEo que siguen la dieta de exclusión de los seis grupos de alimentos (DESGA) y conocer sus posibles carencias nutricionales.Métodos: estudio transversal descriptivo en un grupo de pacientes con EEo que inició tratamiento con DESGA durante el periodo de marzo de 2013 hasta marzo de 2015. Se evaluó la ingesta mediante registro de 72 horas. Se compararon los resultados con las referencias para población adulta sana española (23). Para el análisis estadístico se usaron los test de Mann-Whitney, Krhuskall-Wallis y Chi-cuadrado. Significación p < 0,05.Resultados: se incluyeron en el estudio 14 pacientes. En algunos de ellos, la ingesta dietética siguiendo DESGA fue deficitaria en energía, proteínas y fibra. Tampoco consiguieron cubrir las ingestas de micronutrientes de calcio, zinc, magnesio, ácido fólico, niacina y vitaminas B2 y D, teniendo en cuenta edad y sexo, el 60% de la muestra.Conclusiones: el abordaje terapéutico mediante DESGA, teniendo en cuenta las características de la dieta, debe acompañarse de una evaluación periódica del estado nutricional, que incluya micronutrientes y una pauta de suplementación específica.

Ingesta dietética de pacientes adultos con esofagitis eosinofílica que siguen una dieta de exclusión de seis grupos de alimentos / Dietary intake for adult eosinophilic esophagitis patients following a six-food-groups elimination diet

Introducción: la esofagitis eosinofílica (EEo) es una enfermedad inmunoalérgica crónica emergente en adultos. Surge como respuesta disfuncional frente a los antígenos de los alimentos y se caracteriza por síntomas recurrentes de disfunción esofágica e inflamación. El tratamiento farmacológico y dietético se basa en su patogénesis y debe ser individualizado. Uno de los posibles abordajes dietéticos se basa en la eliminación empírica de alimentos que con mayor frecuencia causan EEo. Objetivo: evaluar la ingesta dietética de los pacientes con EEo que siguen la dieta de exclusión de los seis grupos de alimentos (DESGA) y conocer sus posibles carencias nutricionales. Métodos: estudio transversal descriptivo en un grupo de pacientes con EEo que inició tratamiento con DESGA durante el periodo de marzo del 2013 hasta marzo del 2015. Se evaluó la ingesta mediante registro de 72 h. Se compararon los resultados con las referencias para población adulta sana española Moreiras, 2013. Para el análisis estadístico se usaron los test de Mann-Whitney, Krhuskall-Wallis y chi cuadrado. Signifi cación p < 0,05. Resultados: se incluyeron en el estudio 14 pacientes. En algunos de ellos, la ingesta dietética siguiendo DESGA fue deficitaria en energía, proteínas y fibra. Tampoco consiguieron cubrir las ingestas de micronutrientes de calcio, zinc, magnesio, ácido fólico, niacina y vitaminas B2 y D, teniendo en cuenta edad y sexo, el 60% de la muestra. Conclusiones: el abordaje terapéutico mediante DESGA, teniendo en cuenta las características de la dieta, debe acompañarse de una evaluación periódica del estado nutricional, que incluya micronutrientes y una pauta de suplementación específica (AU)

Introduction: Eosinophilic esophagitis (EoE) is an emerging chronic immune/antigen mediated inflammatory disease in adults. It develops as a dysfunctional response to food antigens and is characterized by recurrent symptoms of esophageal dysfunction and inflammation. Drug and dietary treatment are based on its pathogenesis and should be individualized. One of the possible dietary approaches is based on empirical elimination of foods which most commonly cause EoE. Objective: To evaluate dietary intake of patients who follow the diet consisting of the exclusion of six food groups (DESGA) and to know its potential nutritional deficiencies. Methods: Cross-sectional study of patients who started treatment with DESGA diet between March 2013 and March 2015. A 72 h dietary record was completed. The results were compared with the references for the Spanish healthy adult population Moreiras, 2013. Statistical analysis included Mann-Whitney, Kruskal-Wallis and Chi-square tests. Significance was set at p < 0.05. Results: The study included 14 patients. For some of them, the DESGA diet was defi cient inenergy, protein and fiber. Taking into account age and sex, sixty percent of the sample did not get adequate amount of calcium, zinc, magnesium, folic acid, niacin, vitamin B2 and vitamin D. Conclusions: Considering the characteristics of the DESGA diet, this therapeutic approach must be accompanied by a periodic assessment of nutritional status, including micronutrients and a pattern of specific supplementation (AU)

Increased pain relief with remifentanil does not improve the success rate of external cephalic version: a randomized controlled trial.

INTRODUCTION: Our objective was to compare the effect of two pain relief methods (remifentanil vs. nitrous oxide) on the success rate of external cephalic version. MATERIAL AND METHODS: We conducted a randomized open label parallel-group controlled single-center clinical trial with sequential design, at Cruces University Hospital, Spain. Singleton pregnancies in noncephalic presentation at term that were referred for external cephalic version were assigned according to a balanced (1:1) restricted randomization scheme to analgesic treatment with remifentanil or nitrous oxide during the procedure. The primary endpoint was external cephalic version success rate. Secondary endpoints were adverse event rate, degree of pain, cesarean rate and perinatal outcomes. RESULTS: The trial was stopped early after the second interim analysis due to a very low likelihood of finding substantial differences in efficacy (futility). The external cephalic version success rate was the same in the two arms (31/60, 51.7%) with 120 women recruited, 60 in each arm. The mean pain score was significantly lower in the remifentanil group (3.2 ± 2.4 vs. 6.0 ± 2.3; p < 0.01). No differences were found in external cephalic version-related complications. There was a trend toward a higher frequency of adverse effects in the remifentanil group (18.3% vs. 6.7%, p = 0.10), with a significantly higher incidence rate (21.7 events/100 women vs. 6.7 events/100 women with nitrous oxide, p = 0.03). All reported adverse events were mild and reversible. CONCLUSIONS: Remifentanil for analgesia decreased external cephalic version-related pain but did not increase the success rate of external cephalic version at term and appeared to be associated with an increased frequency of mild adverse effects.

Probability of cesarean delivery after successful external cephalic version.

OBJECTIVE: To identify factors associated with cesarean delivery following successful external cephalic version (ECV). METHODS: In a prospective study, data were obtained for ECV procedures performed at Cruces University Hospital, Spain, between March 2002 and June 2012. Women with a singleton pregnancy who had a successful, uncomplicated ECV and whose delivery was assisted at the study hospital, with the fetus in cephalic presentation, were included. A multivariate model of risk factors of cesarean delivery was developed. RESULTS: Among 627 women included, 92 (14.7%) delivered by cesarean. A cesarean was performed among 33 (8.5%) of 387 women with spontaneous labor versus 59 (24.6%) of 240 who were induced (P < 0.001). Multivariate analysis showed that higher BMI (P = 0.006), labor induction (P = 0.001), and prior cesarean (P < 0.001) were associated with cesarean. Time between ECV and delivery was inversely associated with probability of cesarean during the first 2 weeks. Thus, the probabilities of cesarean delivery on the first day were 0.53 (95% CI 0.35-0.71) and 0.34 (95% CI 0.18-0.51) following induced and spontaneous labor, respectively. On the seventh day, the probabilities were 0.23 (95% CI 0.15-0.32) and 0.12 (95% CI 0.07-0.18), respectively. CONCLUSION: Following ECV, induction of labor, an interval of less than 2 weeks to delivery, BMI, and previous cesarean were associated with an increased risk of cesarean.

Relatively high levels of anti-HLA antibodies (measured by Luminex Single-Antigen bead assay) are required to mediate inhibition of lymphocyte proliferation induced by sera from alloimmunized renal patients.

BACKGROUND: Rejection of transplanted organs is caused by alloimmune responses, primarily against HLA molecules. Anti-donor HLA antibodies are associated with antibody-mediated rejection (AMR) and poor graft outcome. Because of clinical interest in detecting these antibodies, new technologies have recently been introduced to increase the sensitivity of detection. The Luminex Single-Antigen (LSA) bead assay may yield new information, but it must be validated against biological and clinical data. MATERIAL AND METHODS: Based on previously published data regarding the in vitro effects of anti-HLA antibodies on lymphocytes, we measured the effect on lymphocytes of sera from patients on the transplant waiting list who had high titers of anti-HLA antibodies. Anti-CD3-mediated lymphocyte activation was studied in the presence of whole serum from these patients. Changes in lymphocyte proliferation, measured by carboxyfluorescein succinimidyl ester (CFSE) labeling, were detected, and these changes correlated with the level of anti-HLA antibodies. RESULTS: Whole serum containing anti-HLA antibodies inhibited lymphocyte proliferation; this effect correlated with the level of antibodies, as measured by LSA. This inhibitory effect was HLA-specific, as shown by adsorption experiments. We also found that relatively high levels of anti-HLA antibodies were necessary to induce changes in an in vitro model of lymphocyte proliferation. CONCLUSIONS: Our results demonstrate the clinical utility of detecting anti-HLA antibodies by LSA.

Induction at 41 weeks increases the risk of caesarean section in a hospital with a low rate of caesarean sections.

OBJECTIVE: To analyse the impact of a change in the management of prolonged pregnancies from inducing labour at 42(+0) to induction at 41(0-6). DESIGN: Retrospective cohort study. METHODS: Analysis of 3563 single pregnancies with cephalic presentation of ≥ 41 weeks of gestation delivered in Cruces University Hospital (Spain). Two cohorts were compared corresponding to before and after the change in the policy on induction. MAIN OUTCOME MEASURES: Induction rate, vaginal delivery rate, newborn morbidity and mortality. RESULTS: The overall rate of caesarean sections in the patients included in the study was 12.8% (19.5% among those induced and 8.4% among those in whom the onset of labour has been spontaneous). The caesarean section rate in cohorts 41(0-6) and 42(+0) were 14.1% and 11.4%, respectively (p=0.01). Though there were more newborns with umbilical cord blood ph<7.10 in cohort 41(0-6) than in the other group (8.7% versus 4.5%; p<0.01), no significant differences were found between cohorts in 5-min Apgar score < 7, number of admissions to the neonatal care unit or perinatal mortality. CONCLUSION: The induction of labour during week 41 in prolonged pregnancies may increase the rate of caesarean sections in hospitals with low rates of caesarean sections.

Clinical score for the outcome of external cephalic version: a two-phase prospective study.

AIM: To design a score based on clinical parameters to predict the outcome of external cephalic versions (ECVs) at term. MATERIALS AND METHODS: A two-phase study was conducted (analysis/design and prospective validation) regarding 1000 versions performed between March 2002 and November 2010. The variables considered in the score were selected based on the results of multiple logistic regression models and multiple correspondence analyses published by our group. The predictive capacity was estimated through the area under the ROC curve. RESULTS: The success rates for ECV in phases 1 and 2 were 52.2 and 51.2%, respectively, making the overall success rate 51.7%. The score was designed with the variables parity, placental location, breech variety and amount of amniotic fluid giving a value for each one. A clinical recommendation, based on the result of the score, was the estimated success rate with the 95% confidence interval. The predictive capacity of the score for the outcome of ECV at term was 70.1% (95% CI 66.9-73.4). CONCLUSIONS: A score composed of four easily measurable variables enabled us to predict the outcome of ECV at term.