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Chile, and several Latin American countries, use the Atalah standard to assess nutritional status during pregnancy. However, this standard (underweight: pre-pregnancy body mass index (BMI)

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

Objective To evaluate whether pregestational obesity is associated with the risk of caesarean section in pregnant women living in a country in an advanced stage of the obstetric transition. Methods Retrospective cohort study. Data were collected from prenatal and hospital records. Pregestational obesity was defined as: body mass index, [weight(k)/height (m2)] ≥30, and caesarean sections were categorized as elective, emergency, or non-emergency/medically necessary. Biodemographic and sociodemographic characteristics, obstetric and perinatal pathologies, and maternal anthropometric variables were assessed. Chi-square and t-tests were used to compare qualitative and quantitative variables, respectively. Simple and adjusted generalized linear models were used to evaluate the association between pregestational obesity and caesarean delivery. Finally, population attributable risk was calculated. Data analysis was performed using STATA.v.14.0. Participants 2309 pregnant women with a singleton pregnancy who gave birth at a public hospital in the Metropolitan Region of Santiago, Chile in 2015. Results The prevalence of pregestational obesity was 21.4%, and the incidence of caesarean deliveries was 34.8% (33% of which corresponded to elective, 46% to emergency, and 21% to non-emergency/medically necessary caesarean deliveries). Pregestational obesity increased the risk of caesarean delivery (aRR = 1.46; 95%CI. [1.19–1.79] as well as the risk of elective (aRR = 1.74; 95%CI. [1.23–2.45]) and emergency caesarean delivery (aRR = 1.44; 95%CI. [1.03–2.00]). The population attributable risk of pregestational obesity for caesarean section was 32%. Conclusion Given the significant association between pregestational obesity and caesarean delivery, it is necessary to develop strategies to decrease obesity among women of childbearing age in order to decrease obstetric intervention.

RESUMEN Objetivos: Comparar indicadores materno-perinatales entre gestantes chilenas y peruanas en Santiago de Chile entre enero y julio del 2017. Materiales y métodos: Estudio transversal analítico en 1578 chilenas y 318 peruanas atendidas en un hospital clínico de Santiago. Se realizó un análisis comparativo de las variables materno-perinatales por nacionalidad. Se realizaron modelos logísticos crudos y ajustados con sus intervalos de confianza al 95% (IC 95%). Resultados: Las gestantes peruanas residían en promedio 5,7 años en Chile, tenían más edad (28,1 ± 6,5 vs. 26,6 ± 6,5 años), menos desocupación (52,3% vs. 60,6%), más probabilidad de ingreso tardío al control prenatal (CP) (OR: 2,17, IC 95%: 1,69-2,78) y de tener anemia (OR: 3,45, IC 95%: 2,13-5,56) asociada al ingreso tardío a CP (OR ajustado: 0,43, IC95%: 0,33-0,56). Las gestantes chilenas tuvieron una mayor probabilidad de obesidad al ingreso al CP (OR: 2,48 IC 95%: 1,81-3,41) y al parto (OR: 2,03, 1,57-2,62). Así como, de diabetes gestacional (DG) (OR: 2,12, IC 95%: 1,24-3,61), parto prematuro (OR: 2,82, IC 95%: 1,59-5,01) e hijos con bajo peso al nacer (BPN) (OR: 3,10, IC 95%: 1,51-6,33). En el modelo ajustado la obesidad se asoció en forma independiente a la DG (OR ajustado: 3,8, IC 95%: 2,44-6,18) y al BPN (OR ajustado: 3,34, IC95%: 2,33-4,85. Conclusiones: El efecto del migrante sano se observa en gestantes inmigrantes peruanas, principalmente en resultados perinatales. Es necesario favorecer el ingreso precoz a la atención prenatal, prevenir la anemia y la obesidad, para evitar resultados materno-perinatales adversos en esta población. ABSTRACT Objectives: To compare maternal and perinatal outcomes between Chilean and Peruvian pregnant women in Santiago, Chile, between January and July 2017. Materials and methods: Analytical cross-sectional study of 1,578 Chilean and 318 Peruvian women who attended a clinical hospital in Santiago. We conducted a comparative analysis of maternal and perinatal variables by nationality. Crude and adjusted logistic models were carried out with a 95% confidence interval (95% CI). Results: Peruvian pregnant women resided an average of 5.7 years in Chile, were older (28.1 ± 6.5 vs. 26.6 ± 6.5 years), had less unemployment (52.3% vs. 60.6%), were more likely to enter prenatal care (PC) late (OR: 2.17, 95% CI: 1.69-2.78) and had higher probability of having anemia (OR: 3.45, 95% CI: 2.13-5.56) associated with late entry to PC (adjusted OR: 0.43, 95% CI: 0.33-0.56). On the other hand, Chilean pregnant women were more likely to be obese upon entry to PC (OR: 2.48, 95% CI: 1.81-3.41) and at the time of delivery (OR: 2.03, 95% CI: 1.57-2.62). In addition, Chilean women had higher rates of gestational diabetes (GD) (OR: 2.12, 95% CI: 1.24-3.61), premature delivery (OR: 2.82, 95% CI: 1.59-5.01) and low birth weight (LBW) (OR: 3.10, 95% CI: 1.51-6.33). In the adjusted model, obesity was independently associated with GD (adjusted OR: 3.8, 95% CI: 2.44-6.18) and LBW (adjusted OR: 3.34, 95% CI: 2.33-4.85). Conclusions: The healthy immigrant effect was observed in pregnant Peruvian immigrants, mainly regarding the perinatal outcomes. It is necessary to promote early access to prenatal care and to stablish measures to prevent anemia and obesity, in order to avoid adverse maternal and perinatal outcomes in the studied population.

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To compare maternal and perinatal outcomes between Chilean and Peruvian pregnant women in Santiago, Chile, between January and July 2017.Analytical cross-sectional study of 1,578 Chilean and 318 Peruvian women who attended a clinical hospital in Santiago. We conducted a comparative analysis of maternal and perinatal variables by nationality. Crude and adjusted logistic models were carried out with a 95% confidence interval (95% CI).Peruvian pregnant women resided an average of 5.7 years in Chile, were older (28.1 ± 6.5 vs. 26.6 ± 6.5 years), had less unemployment (52.3% vs. 60.6%), were more likely to enter prenatal care (PC) late (OR: 2.17, 95% CI: 1.69-2.78) and had higher probability of having anemia (OR: 3.45, 95% CI: 2.13-5.56) associated with late entry to PC (adjusted OR: 0.43, 95% CI: 0.33-0.56). On the other hand, Chilean pregnant women were more likely to be obese upon entry to PC (OR: 2.48, 95% CI: 1.81-3.41) and at the time of delivery (OR: 2.03, 95% CI: 1.57-2.62). In addition, Chilean women had higher rates of gestational diabetes (GD) (OR: 2.12, 95% CI: 1.24-3.61), premature delivery (OR: 2.82, 95% CI: 1.59-5.01) and low birth weight (LBW) (OR: 3.10, 95% CI: 1.51-6.33). In the adjusted model, obesity was independently associated with GD (adjusted OR: 3.8, 95% CI: 2.44-6.18) and LBW (adjusted OR: 3.34, 95% CI: 2.33-4.85).The healthy immigrant effect was observed in pregnant Peruvian immigrants, mainly regarding the perinatal outcomes. It is necessary to promote early access to prenatal care and to stablish measures to prevent anemia and obesity, in order to avoid adverse maternal and perinatal outcomes in the studied population.Comparar indicadores materno-perinatales entre gestantes chilenas y peruanas en Santiago de Chile entre enero y julio del 2017.Estudio transversal analítico en 1578 chilenas y 318 peruanas atendidas en un hospital clínico de Santiago. Se realizó un análisis comparativo de las variables materno-perinatales por nacionalidad. Se realizaron modelos logísticos crudos y ajustados con sus intervalos de confianza al 95% (IC 95%).Las gestantes peruanas residían en promedio 5,7 años en Chile, tenían más edad (28,1 ± 6,5 vs. 26,6 ± 6,5 años), menos desocupación (52,3% vs. 60,6%), más probabilidad de ingreso tardío al control prenatal (CP) (OR: 2,17, IC 95%: 1,69-2,78) y de tener anemia (OR: 3,45, IC 95%: 2,13-5,56) asociada al ingreso tardío a CP (OR ajustado: 0,43, IC95%: 0,33-0,56). Las gestantes chilenas tuvieron una mayor probabilidad de obesidad al ingreso al CP (OR: 2,48 IC 95%: 1,81-3,41) y al parto (OR: 2,03, 1,57-2,62). Así como, de diabetes gestacional (DG) (OR: 2,12, IC 95%: 1,24-3,61), parto prematuro (OR: 2,82, IC 95%: 1,59-5,01) e hijos con bajo peso al nacer (BPN) (OR: 3,10, IC 95%: 1,51-6,33). En el modelo ajustado la obesidad se asoció en forma independiente a la DG (OR ajustado: 3,8, IC 95%: 2,44-6,18) y al BPN (OR ajustado: 3,34, IC95%: 2,33-4,85.El efecto del migrante sano se observa en gestantes inmigrantes peruanas, principalmente en resultados perinatales. Es necesario favorecer el ingreso precoz a la atención prenatal, prevenir la anemia y la obesidad, para evitar resultados materno-perinatales adversos en esta población.

Antecedentes: La Escuela de Obstetricia de la Universidad de Chile fue pionera en implementar un plan de formación basado en competencias en 2009, en el marco del inicio de la innovación curricular de la Facultad de Medicina. Objetivo: Describir la percepción estudiantil de la primera evaluación de ciclo curricular, correspondiente a los dos primeros años de la carrera, durante el año 2017. Material y Método: El estudio es de diseño mixto convergente. La recolección de datos se realizó a través de encuestas autoaplicadas. Participaron 47 estudiantes que habían finalizado los dos primeros años de su formación. Se realizó un análisis descriptivo de la encuesta de salida con 14 preguntas y dos preguntas adicionales abiertas sobre fortalezas y debilidades de su formación curricular. Resultados: Casi un cien por ciento de los participantes estuvo de acuerdo con la formación curricular y la coherencia de los cursos del plan de estudios. Dentro de los aspectos a mejorar destacan que no se entregó suficiente retroalimentación en las evaluaciones y que el tiempo no presencial de los cursos fue escaso. De forma positiva mencionaron la formación y disponibilidad del equipo docente, la progresión de contenidos en el plan de formación y las estrategias didácticas. Conclusión: En general la percepción fue positiva en relación al primer ciclo curricular del plan de formación basado en competencias, destacando su coherencia y equipo docente. La sobrecarga académica y la retroalimentación fueron los principales aspectos a mejorar, lo cual permitió implementar estrategias de mejora en el plan de formación. Este estudio evidencia la importancia de la evaluación y seguimiento constante curricular.

Objectives One of every four pregnant women in Chile is obese. Gestational obesity is associated with maternal metabolic complications in pregnancy (e.g., gestational diabetes, preeclampsia), but to our knowledge, there is little evidence on relationships with future metabolic risk. The aim of this study was to evaluate the association between prepregnancy obesity (prepregnancy body mass index ≥30 kg/m 2 ) or excessive gestational weight gain (GWG; according to the 2009 recommendations from the Institute of Medicine), and maternal metabolic complications 10 y postpartum in premenopausal Chilean women. Methods A prospective study was conducted. In 2006, 1067 Chilean mothers of children born in 2002—participants of the GOCS (Growth and Obesity Cohort Study)—were recruited. Mothers completed a questionnaire concerning sociodemographic, anthropometric, and pregnancy characteristics. Of the sample, 402 women were randomly selected to participate in a study related to the determinants of breast cancer risk in 2012. At follow-up, anthropometry, blood pressure, and fasting labs were measured. Complete data was available for 366 women. Results Thirty-two percent of mothers had prepregnancy overweight/obesity and 39.1% had excessive GWG. In adjusted models, prepregnancy obesity was positively associated with increased insulin resistance (odds ratio [OR], 18; 95% confidence interval [CI], 5.2–62.7), metabolic syndrome (OR, 3.3; 95% CI, 1.3–8.3), and hyperglycemia (OR, 3; 95% CI, 1.1–8.6). Prepregnancy overweight/obesity was associated with increased risk for insulin resistance, metabolic syndrome, abdominal obesity, low high-density lipoprotein cholesterol, and hypertriglyceridemia ( P Conclusions Gestational obesity was associated with maternal metabolic alterations 10 y postpartum. Prevention strategies for chronic diseases should consider prepregnancy obesity as a modifiable risk factor for future metabolic health.

Some nutritional interventions have shown their efficacy in reducing gestational weight gain (GWG); however, their applicability in routine care is limited.We assessed the effectiveness of a low-intensity and high-coverage nutritional intervention on maternal and offspring outcomes; the intervention enhanced existing nutritional health care standards and practices at the primary health care level in Chile.This study was a cluster-randomized controlled trial of 12 primary health care centers (PHCCs) from Santiago, Chile. PHCCs were randomly allocated to either nutritional intervention [intervention group (IG), n = 5] or routine care [control group (CG), n = 7]. A total of 4631 pregnant women were recruited (IG, n = 2565; and CG, n = 2066). Primary outcomes were adequate GWG and glycemic control in mothers and birth weight, birth length, macrosomia, and large for gestational age in neonates. The intervention consisted of 4 key actions: training of health care professionals on nutritional recommendations, counseling of pregnant women on diet and physical activity recommendations, offering a physical activity program implemented in the participating PHCCs, and adequate referral to dietitians. Women randomly assigned to the CG received routine antenatal care.At baseline, the mean age was 26.1 y; 45% of women were primipara and 24% were obese. No differences were found in the percentage of women achieving adequate GWG (IG: 30.3%, compared with CG: 31.3%; OR: 0.94; 95% CI: 0.81, 1.09), but women in the IG had lower GWG than those in the CG (11.3 compared with 11.9 kg; mean difference: -0.63 kg; 95% CI: -1.19, -0.08). Effects of the intervention were significantly higher in women with obesity at the begining of pregnancy (mean difference: -1.24 kg; 95% CI: -2.18, -0.30; P for interaction 0.05). No differences were found between groups regarding maternal glycemic control or neonatal outcomes.Our findings demonstrate that a low-intensity, high-coverage intervention delivered through the Chilean public health care system under standard operating conditions reduces GWG and has the potential for successful scale-up. This trial was registered at clinicaltrials.gov as NCT01916603.

PEGylated biotherapeutics can elicit anti-PEG (polyethylene glycol) immune responses in patients treated with this category of drugs. While anti-PEG antibody assays for this class of biotherapeutics have become a common element of the clinical immunogenicity testing strategy, the overall antibody incidence induced by the nanoparticle (NP) delivery system (such as ACCURINS®) has not been fully studied to date. To support the immunogenicity assessment of one of Pfizer’s NP-based therapeutics, consisting of gedatolisib (GEDA) encapsulated in ACCURINS® (GEDA-NP), we developed an anti-GEDA-NP antibody (ADA) assay on the MSD platform for the detection of GEDA-NP induced ADA in human serum. The focus of our strategy was on developing a clinically relevant ADA assay and systematically addressing assay interference through rigorous assay optimization. Our efforts led to a fit-for-purpose assay for the detection of anti-GEDA-NP ADA in serum samples obtained from breast cancer patients. Results from method qualification indicated robust assay performance, as highlighted by inter and intra-assay precision within 25% CV for all controls, and reproducible response profiles across multiple runs during the assessment of assay cut points with breast cancer samples. The assay sensitivity was between 4.3 ng/mL and 123 ng/mL for surrogate positive controls of IgG and IgM isotypes, respectively. Additionally, assay interference from nonspecific matrix proteins and circulating drug was addressed, which ensured accurate assessment of ADA incidence that can be attributed to GEDA-NP.

Anti-drug antibody (ADA) assay selectivity is evaluated during assay validation to assess the potential for individual matrices to interfere with detection of ADA. While current EMA and FDA guideline documents suggest comparative analysis with and without matrix, they do not provide specific recommendations on the acceptance criteria such as an acceptable percent positive control (PC) recovery range or positive rate. Industry has adopted an approach where recovery of PC spiked sample is expected to fall within ± 20% (80 to 120%) vs. that for the PC material spiked in negative control matrix or assay buffer. Here, it is proposed that ADA assay selectivity evaluated using a qualitative assessment of PC recovery vs. a PK-like quantitative method may be more appropriate. The PC recovery test should focus on the reliability of the method to detect the low PC level in individual samples and avoid false-negative ADA reporting. Therefore, it is proposed that assessment of high PC level as well as the assessment of quantitative percent recovery (within ± 20%) should not be included in the test. The recovery test may be viewed as acceptable should a pre-selected number of individual samples (for example at least 8 or 9 out of 10) prepared at the low PC concentration of the assay score as ADA positive.

Assays for the detection and confirmation of anti-drug antibodies (ADA) are commonly used tools for assessing the immunogenicity of drug candidates in both clinical and nonclinical studies. During the development of such assays, it is typical to optimize the assay conditions based on factors such as sensitivity or signal/noise ratio (S/N) and is commonly done using an assay positive control (PC). However, even carefully optimized methods often suffer with problems due to low cut-point factors and failure to distinguish assay “noise” from a true biological response. In this paper, we describe an approach to assay development in which the impacts of assay conditions on the response and variability, both analytical and biological, of drug-naive samples are tested by way of PC-independent assay condition optimization. Using two ADA methods as model systems, we examine the impact of minimum required dilution, assay reagent (labeled drug) concentrations, incubation time, assay, and wash buffer composition. We find that the choice of assay conditions, particularly the labeled drug concentration, can greatly affect the distribution of naive sample responses and thus impact screening and confirmatory assay cut-points. In two case studies presented, screening assay cut-point (SCP) varied from 1.38 to 2.20 and 1.04 to 1.20 while the confirmatory assay cut-point (CCP) varied from 58.5 to 95.6% and 26.2 to 16.2% depending on the conditions tested. Some of the conditions produced unacceptably high CCP values. It is proposed that the degree of the observed impact of the assay conditions on SCP and CCP values depends on the compound nature and assay matrix composition and is likely connected with the diversity of interactions between drug protein and matrix components. Because it was also observed that higher assay SCP can associate with a loss of the PC-based assay sensitivity, additional assessment of the assay conditions would be required to determine an overall assay performance acceptability, including assay PC-based sensitivity, drug, and target tolerance characteristics. In conclusion, it is suggested that by assessing performance of treatment-naive samples at various assay conditions, one can identify potential assay protocols that allow to avoid undesirably low screening (e.g.

Objective: Evaluate if an intervention based on nutritional counseling decreases total sugars and energy consumption in overweight and obese pregnant women, compared to their previous consumption and compared to women who only received routine counseling. Methods: Randomized study of two groups: dietary counseling (Intervention Group: IG) and routine counseling (Control Group: CG). The intervention consisted of three educational sessions focused on decreasing intake of foods that most contribute to sugars consumption. Changes in sugars and energy consumption were evaluated by a food frequency questionnaire before and after the intervention. Results: We evaluated 433 pregnant women, 272 in IG and 161 in CG, who before intervention had a mean consumption of 140 g total sugars and 2134 kcal energy per day. At the end of the intervention, the IG showed 15 g/day lower consumption of total sugars (95% CI: &minus, 25 and &minus, 5 g/day), 2% less total energy from sugars (95% CI: &minus, 3% and &minus, 1% g/day), and 125 kcal/day less energy than the CG (95% CI: &minus, 239 and &minus, 10 kcal/day). Table sugar, sweets, and soft drinks had the greatest reduction in consumption. Conclusions: The intervention focused on counseling on the decrease in consumption of the foods that most contribute to sugars consumption in overweight and obese pregnant women was effective in decreasing total sugars and energy consumption, mainly in the food groups high in sugars. Future studies should examine if this intervention has an effect on maternal and fetal outcomes.

International migration is an increasing public health concern, particularly regard to maternal and neonatal health.To compare obstetric and neonatal variables among native and immigrant childbearing women in a clinical hospital in Santiago, Chile.A cross-sectional, analytic study with 2598 childbearing women and their newborn examined between January and July 2015. Data were collected from clinical records by students who had previously been trained. Ethical approval was obtained from the local Ethics Committee at the hospital. All participants signed an informed consent form. A descriptive and comparative analysis was performed. For comparison, a Chi-square test was used for categorical variables, and Student t-test was used for quantitative variables.Among the included women, 41.5% (n = 1078) were immigrants. The immigrants' mean age was 28.1 ± 6.4 years, and that of natives was 26.8 ± 6.9 (p 0.001). Among natives, the obesity rate was 38.3%, as compared to 19.3% among immigrants (p 0.001). A significantly higher rate of caesarean section was seen among natives (36.8%) than among immigrants (31.7%). Obstetric morbidity, pre-eclampsia, gestational diabetes and prematurity were significantly higher among natives. There was no difference regarding low birth weights.In general, immigrants present better maternal and neonatal indicators than native women. Controversially, this is known as the 'healthy immigrant' phenomenon in the literature.

Background Lifestyle interventions are the primary prevention strategy for gestational diabetes (GDM) in obese/overweight women; however, these interventions have shown limited effectiveness. Omega-3 polyunsaturated fatty acids (PUFAs) intake has shown beneficial effects on glucose metabolism, lipid fractions and inflammatory factors in women who already have GDM. Combining PUFAs supplementation with a lifestyle intervention could achieve lower increase of glucose levels by improving insulin sensitivity. Our aim is to assess two prenatal nutritional interventions (home-based dietary counseling and/or docosahexaenoic acid (DHA) supplementation) delivered to obese/overweight women during pregnancy for them and their offspring to achieve better metabolic control. Methods/design Randomized controlled trial, 2 × 2 factorial design. Eligible pregnant women will be randomly allocated to one of the four parallel arms: 1) Home-based dietary counseling +800 mg/day DHA supplementation (n = 250); 2) 800 mg/day DHA (n = 250); 3) Home-based dietary counseling +200 mg/day DHA (n = 250); 4) 200 mg/day DHA (n = 250). Primary outcomes are: GDM; macrosomia; and neonatal insulin resistance. Data analyses will be done on an intention-to-treat basis. Discussion We expect the present study to contribute to the understanding of the potential effectiveness of an omega-3 supplementation on the risk of developing GDM in overweight/obese pregnant women. We will also test if the combination of having better dietary habits alongside with omega 3 supplementation will improve insulin sensitivity and as consequence, a lower elevation of glucose levels could be achieved. Trial Registration: NCT02574767

Background: Women in childbearing ages (WCBA) represent a strategic intervention group to reverse the global trend of increasing obesity. Aim: To conduct a review of studies reporting obesity prevalence in WCBA in Chile in the last 25 years. Material and Methods: To describe obesity prevalence, we used three approaches, namely qualitative review of studies describing obesity prevalence in WCBA and a comparative study of the prevalence of obesity, overweight, abdominal and morbid obesity in WCBA from 2003 and 2009-10 National Health Surveys (ENS). Finally, nutrition status trends of pregnant women in the period 1987-2013 were plotted. Results: According to ENS, obesity prevalence exceeded 20% and excess weight 50%, both in 2003 and 2009-10 surveys. We found seven population studies, being difficult to compare them due to the heterogeneity of obesity definitions, design, and populations. Population studies showed that the prevalence of obesity increases along with age. The higher prevalence of obesity in WCBA aged 20 to 43 years was found in the city of San Carlos in 2007 (35.5%). The lowest was found in female university students, ranging from 0% to 5.9%. Obesity in pregnant women increased from 12.9% to 32.2% in the period 1987-2004 and from 20.3% to 26.3% in the period 2005- 2013. Conclusions: There is a high and increasing prevalence of obesity among women in childbearing age, whether pregnant or not-pregnant

Accurate measurement of in vitro cell growth is critical for oncology drug development, but cell counting and the most accurate indirect proliferation assays are impractical. Here, we describe a robust alternative method that monitors proliferating cell thymidine kinase 1 (TK1) activity via LC-MS/MS quantification of 3'-deoxy-3'-fluorothymidine (FLT) and its monophosphate metabolite FLT-MP. LNCaP prostate cancer cells were cultured at four densities (20,000; 10,000; 5000; and 500 cells/well) and incubated with 2000 ng/mL FLT in multi-well plates. Internal standards were FLT-d3 for FLT and d4-thymidine for FLT-MP. In culture medium, peak area ratios of FLT to FLT-d3 and FLT-MP to d4-thymidine were linear over the range 0.25-100 ng/mL (r(2)≥0.998). Accuracy for quality controls was between -7.3% and 6.3% for FLT, and from -3.3% to 1.7% for FLT-MP. Quality control precision was from 2.4% to 5.7% for FLT and 3.2% to 7.5% for FLT-MP. The limit of quantification was 0.25 ng/mL, with good control results (precision of 9.6% for FLT and 14.8% for FLT-MP). FLT-MP formation was linearly proportional to cell number from 500 to 20,000 cells/well 1 h after FLT addition. FLT-MP and ATP generation were comparable in LNCaP cells exposed to cell cycle inhibitor drugs (Spearman r=0.925, p0.0001), demonstrating assay suitability for drug screening. This fit for purpose method is amenable to analysis of tumor tissue extracts, and should enable direct assessment of in vitro-in vivo relationships in animal models of cancer.

Epidemiological studies suggest that broccoli can decrease risk for cancer. Broccoli contains many bioactives, including vitamins C and E, quercetin and kaempferol glycosides and, like other members of the Brassicaceae, several glucosinolates, including glucobrassicin (3-indolylmethyl glucosinolate) and glucoraphanin (4-methylsulphinylbutyl glucosinolate). A key bioactive component responsible for much of this activity may be sulforaphane (1-isothiocyanato-4-methylsulfinylbutane), a hydrolysis product of glucoraphanin. Sulforaphane not only upregulates a number of phase II detoxification enzymes involved in clearance of chemical carcinogens and reactive oxygen species, but has anti-tumorigenic properties, causing cell cycle arrest and apoptosis of cancer cells. The bioequivalency of sulforaphane and whole broccoli have not been fully evaluated, leaving it unclear whether whole broccoli provides a similar effect to purified sulforaphane, or whether the presence of other components in broccoli, such as indole-3-carbinol from glucobrassicin, is an added health benefit. Dietary indole-3-carbinol is known to alter estrogen metabolism, to cause cell cycle arrest and apoptosis of cancer cells and, in animals, to decrease risk for breast cancer. Recent research suggests that both dietary broccoli and the individual components sulforaphane and indole-3-carbinol may offer protection from a far broader array of diseases than cancer, including cardiovascular and neurodegenerative diseases. A common link between these oxidative degenerative diseases and cancer may be aggravation by inflammation. A small body of literature is forming suggesting that both indole-3-carbinol and sulforaphane may protect against inflammation, inhibiting cytokine production. It remains to be seen whether cancer, cardiovascular disease, dementia and other diseases of aging can all benefit from a diet rich in broccoli and other crucifers.

Women in childbearing ages (WCBA) represent a strategic intervention group to reverse the global trend of increasing obesity.To conduct a review of studies reporting obesity prevalence in WCBA in Chile in the last 25 years.To describe obesity prevalence, we used three approaches, namely qualitative review of studies describing obesity prevalence in WCBA and a comparative study of the prevalence of obesity, overweight, abdominal and morbid obesity in WCBA from 2003 and 2009-10 National Health Surveys (ENS). Finally, nutrition status trends of pregnant women in the period 1987-2013 were plotted.According to ENS, obesity prevalence exceeded 20% and excess weight 50%, both in 2003 and 2009-10 surveys. We found seven population studies, being difficult to compare them due to the heterogeneity of obesity definitions, design, and populations. Population studies showed that the prevalence of obesity increases along with age. The higher prevalence of obesity in WCBA aged 20 to 43 years was found in the city of San Carlos in 2007 (35.5%). The lowest was found in female university students, ranging from 0% to 5.9%. Obesity in pregnant women increased from 12.9% to 32.2% in the period 1987-2004 and from 20.3% to 26.3% in the period 2005-2013.There is a high and increasing prevalence of obesity among women in childbearing age, whether pregnant or not-pregnant.

Objetivo: Evaluar la histerectomía vaginal en la resolución de patología uterina benigna, en casos que habitualmente se resuelven por histerectomía abdominal. Método: Estudio prospectivo en 68 pacientes sometidas a histerectomía vaginal en el Servicio de Ginecología del Hospital Claudio Vicuña, de San Antonio, entre junio de 2003 a junio de 2009. Son pacientes sin partos vaginales, algunas nuligestas, la mayoría con cicatrices de cesárea o historia de cirugía pélvica previa. Se separan en dos grupos, uno de dificultad moderada (DM) (útero móvil, vagina >2 dedos de diámetro, fondos de saco bien conformados) y otro de dificultad severa (DS) (útero fijo, vagina 2 fingers diameter, well conserved cul de sac, and severe difficulty (SD): composed by patients with none uterine motility, vagina

EPA and DHA consumption in Chile is markedly below international daily intake recommendations. For improvement of such low intake level, we developed a fortified powdered dairy drink, containing 60 mg/serving of DHA and 14 mg/serving of EPA.to evaluate the effects of DHA consumption during pregnancy, parturition, and in the newborn, on lipid composition of red blood cell membranes and levels of DHA and EPA on human milk during lactation. One hundred and seventy five (175) pregnant women received 2 kg/month of the fortified powdered dairy drink (GE), and 177 received the regular milk provided by the Ministry of Health (GC). We monitored daily intake of the dairy drink and all other sources of DHA and EPA in the diet, and measured general biological indicators during pregnancy, parturition, and in the new born. On a subsample of 14 women on each group (GE and GC), we measured fatty acid composition of red blood cell membranes after 0 and 60 days of consumption with the fortified dairy drink, and levels of DHA and EPA on human milk after 2 months of lactation. Of all women in the study, 16% had no consumption of fish, and 53% had no consumption of sea food. Less than 25% of all women had fish on a weekly basis. Consumption of the fortified dairy drink tripled intake of DHA, from 48.8 mg/day (CI 38.7-57.5) to 147.8 mg/day (CI 128.4-167.9) (p0.001). The GE group had a higher content of DHA on the phospholipids of red blood cell membranes: 11.1% (CI 10.2-13.0) versus 17.9% (CI 12.9-23.0) (p0.002). Concentration of DHA and omega-3 fatty acids increased 50% in milk of women consuming the fortified dairy drink (p0.06). There was alower incidence of preterm parturitions on the GE group (2.8 vs 10.6%), but without statistical significance. The consumption of the fortified dairy drink produced a significant increase of DHA consumption during pregnancy and lactation, and an improved composition of red blood cell membranes, as well as in human milk, proving to be an appropriate intervention strategy for the target population.

DHA is a critical nutrient for pregnant and lactating women, with important functions in brain development and sight acuity of the newborn. In Chile, DHA int...

Objetivo: Analizar los factores que determinan la selección de alimentos en familias pobres de 3 comunas de Santiago. Metodología: Encuesta en 150 familias atendidas por la Fundación Rodelillo respecto a estructura familiar, ingresos, alimentación y motivaciones para seleccionar alimentos. Se clasificó el NSE según línea de pobreza de MIDEPLAN. Resultados: el 41% de las familias eran indigentes, el 42% pobres no indigentes y el 17% no pobres. El ingreso promedio per cápita fue $26.200 ± 15.760 y el 55,9 ± 24,6% de los ingresos se destinaba a alimentación. El 27% había recibido infor mación sobre alimentación en el colegio y el 37% en el consultorio, especialmente por dietoterapia. Las guías y la pirámide alimentaria eran conocidas por el 4 y 26% de las madres respectivamente. Sobre el 80% de las familias consumía bebidas gaseosas y golosinas. Los principales factores para seleccionar los alimentos fueron: económicos, preferencias sensoriales, comodidad, mejor alimentación familiar o mejor crecimiento de los hijos. En las familias pobres la razón económica tuvo mayor importancia (84,6%) y disminuyó la motivación por mejorar alimentación (8,3%) y por preferencias sensoriales (7,1%) (p

BACKGROUND: Maternal obesity before and during pregnancy predicts maternal and infant risks of obesity and its associated metabolic conditions. Dietary and physical activity recommendations during pregnancy as well as weight monitoring are currently available in the Chilean primary health care system. However some of these recommendations are not updated and most of them are poorly implemented. We seek to assess the effectiveness of an intervention that enhances the implementation of updated nutrition health care standards (diet, physical activity, and breastfeeding promotion) during pregnancy on maternal weight gain and infant growth. METHODS: DESIGN & SETTING: Cluster randomized controlled trial. The cluster units will be 12 primary health care centers from two counties (La Florida and Puente Alto) from the South-East Area of Santiago randomly allocated to: 1) enhanced nutrition health care standards (intervention group) or 2) routine care (control group). PARTICIPANTS: Women seeking prenatal care before 15 weeks of gestation, residing within a catchment area of selected health centers, and who express that they are not planning to change residence will be invited to participate in the study. Pregnant women classified as high risk according to the Chilean norms (i.e age 40 years, multiple gestation, pre-gestational medical conditions, previous pregnancy-related issues) and/or underweight will be excluded. INTERVENTION: Pregnant women who attend intervened health care centers starting at their first prenatal visit will receive advice regarding optimal weight gain during pregnancy and diet and physical activity counseling-support. Pregnant women who attend control health clinics will receive routine antenatal care according to national guidelines. We plan to recruit 200 women in each health center. Assuming a 20% loss to follow up, we expect to include 960 women per arm. MAIN OUTCOME MEASURES: 1) Achievement of adequate weight gain based on IOM 2009 recommendations and adequate glycaemic control at 24-28 weeks of pregnancy according to ADA 2011, and 2) healthy infant growth during the first year of age based on WHO standards. DISCUSSION: We expect that the intervention will benefit the participants in achieving adequate weight gain & metabolic control during pregnancy as well as adequate infant growth as a result of an increased impact of standard nutrition and health care practices. Gathered information should contribute to a better understanding of how to develop effective interventions to halt the maternal obesity epidemic and its associated co-morbidities in the Chilean population. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01916603.