Maternal serum cytokine levels in pregnancies complicated with threatened preterm labour.

OBJECTIVE: To investigate serum inflammatory markers in singleton gestations complicated with threatened preterm labour (TPL). METHODS: Pregnant women complicated with TPL (n = 61) were recruited to measure maternal serum levels of a panel of cytokines and C-reactive protein and then compared to controls without TPL, matched for gestational age (n = 64) and term pregnancies in the prodromal phase of labour (PPL) (n = 31). In addition, baseline cytokine levels were compared among cases and controls according to the outcome. RESULTS: Women with TPL displayed higher CRP and white blood counts levels together with lower granulocyte macrophage colony-stimulating factor (GMC-SF) compared to both controls without TPL and to term gestations in the PPL. Also, interleukin 10 (IL-10), IL-6, IL-7, IL-8 and tumour necrosis alpha (TNF-α) levels were found significantly higher in TPL cases as compared to controls without TPL and term women in the PLL. Baseline cytokine levels (except IL-10) were higher among TPL cases who later delivered preterm. TPL cases delivering preterm displayed lower GMC-SF levels as compared to those delivering at term. Multivariate analysis found that gestational age at birth positively correlated with cervical length and inversely with CRP, IL-6 and TNF-α levels (p < 0.0001). CONCLUSIONS: TPL and preterm birth were related to inflammatory changes in the maternal side that correlate with cervical shortening and the initiation of uterine contractions.

Epidemiology, Evolution, and Long-Term Survival of Alcoholic Cirrhosis Patients Submitted to Liver Transplantation in Southeastern Spain.

BACKGROUND: Alcoholic cirrhosis (AC) is a common cause of death among individuals abusing alcohol. In the last resort, liver transplantation (LT) is considered the only solution to save the patient's life, generating socioeconomic and public health problems. Clinical and sociodemographic characteristics, rejection frequency, and short- and long-term graft survival are not well known in end-term AC patients undergoing LT. The aim was to determine the sociodemographic and clinical characteristics, their incidence in LT, main pre- and posttransplant complications, and short- and long-term post-transplant graft survival in AC patients in southeastern Spain. METHODS: The medical records of 1,026 patients who underwent LT over the last 23 years were retrospectively reviewed, and demographic data and posttransplant survivals were analyzed and compared. Biochemical characteristics, major pre- and posttransplant complications and short- and long-term survivals were analyzed in a total of 398 male patients with AC undergoing LT. RESULTS: AC and viral cirrhosis are the main indications for LT in our study. Mostly represented in our study are AC men without associated viral infections with a mean age of 53.06 years. Main pretransplant complications in AC patients are ascites (78.3%) and encephalopathy (43.5%), while acute graft rejection is the most common liver posttransplant complication (26.6%), nevertheless with low graft loss frequency (1.1%). AC and autoimmune cirrhosis show the best posttransplant survival in both the short and long term. Patients with AC included on the waiting list for LT were Child-Pugh class B (52.1%) and Model for End-Stage Liver Disease score of 10 to 19 (71.2%). The highest percentage of AC patient survival was observed at 1 year posttransplant (81.2%) and progressively decreased over time up to 10 years posttransplant (69.6%). Pretransplant complications such as ascites and encephalopathy did not have an influence on the percentage of posttransplant survivals, although better survival rates were observed in nonviral AC patients. CONCLUSIONS: AC without viral infections is the main indication for LT in southeastern Spain although its frequency has decreased in last decade. AC is a good indication for LT for its high survival rate and few posttransplant complications. Despite having a high percentage of pretransplant complications (ascites and encephalopathy) but does not appear to influence survivals being observed posttransplant survival rates above those expected. Conversely, viral infections in the patient with AC decrease patient survivals. The main future goals are design new strategies to detect, treat, and reduce AC frequency in our population and know alcoholic recidivism rate posttransplant in our population.

Maternal serum 25-hydroxyvitamin D and C-reactive protein levels in pregnancies complicated with threatened preterm labour.

OBJECTIVE AND METHODS: To measure 25-hydroxyvitamin D [25(OH)D] and C-reactive protein (CRP) serum levels in singleton gestations complicated with threatened preterm labour (TPL, n = 59) and compare to normal controls matched for gestational age (n = 64). Cases were treated after blood sample according to institutional protocol. Also, analyte levels were compared among cases according to the outcome. RESULTS: Mean serum 25(OH)D levels were similar between cases and controls, with median white blood cell count and CRP levels found significantly higher in TPL cases. Women with TPL delivering preterm displayed shorter mean cervical lengths along with higher CRP and lower 25(OH)D serum levels when compared to those delivering at term. Two multiple linear regression models were constructed to analyse factors related to gestational age at delivery (pooled analysis and only those with TPL). In both models, gestational age positively correlated to cervical length and inversely to CRP levels; whereas, in the TPL model, only 25(OH)D levels correlated positively. CONCLUSION: Women complicated with TPL showed similar serum 25(OH)D yet higher CRP levels as compared to controls. TPL cases delivering preterm displayed lower 25(OH)D and higher CRP correlated levels.

Assessment of obstructive sleep apnea-hypopnea syndrome risk at the end of pregnancy using the Berlin Questionnaire.

OBJECTIVE: To assess the risk of obstructive sleep apnea-hypopnea syndrome (OSAHS) and related factors at the end of pregnancy using the Berlin questionnaire. METHODS: A total of 367 women at the end of pregnancy (median gestational age 39 weeks) were interviewed with the Berlin questionnaire and a general survey containing maternal socio-demographic and anthropometric information. Neonatal outcome data were also assessed. RESULTS: Median age for the whole sample was 31 years. According to the Berlin questionnaire, 39.8% were positive for high risk of OSAHS. Upon bivariate analysis, higher risk of OSAHS was significantly related to church attendance, and higher pre-pregnancy body mass index (BMI), current BMI, weight, neck and arm circumference and systolic blood pressure at survey. Logistic regression analysis found that higher maternal pre-pregnancy BMI (OR 2.71 95% CI 1.84-4.00, p < 0.0001) and higher maternal weight at survey (OR 3.02, 95% CI 1.78-5.17, p < 0.0001) were significantly related to a higher risk of OSAHS. CONCLUSION: The risk of OSAHS is relatively high at the end of pregnancy and related to a higher pre-pregnancy BMI and higher maternal weight at survey. Further studies are needed to confirm our results with a diagnostic tool, such as polysomnography or another similar yet less complicated to carry out procedure.

Telomerase activity and telomere length in women with breast cancer or without malignancy: A systematic review and meta-analysis.

AIM: We performed a systematic review and meta-analysis to assess whether telomerase activity and telomere length are associated with breast cancer. METHODS: PubMed, Web of Science, Embase, LILACS, Scielo, Embase, and CNKI databases were searched to obtain relevant articles published through May 10, 2023, following PRISMA guidelines and a registered PROSPERO protocol (CRD42022335402). We included observational studies reporting telomerase activity or telomere length in patients with breast cancer compared with women with benign lesions or normal tissue (control women). The Newcastle-Ottawa Scale was used to evaluate the quality of studies. Data were expressed as odds ratios (OR) and 95 % confidence intervals (CI). Random effects and inverse variance methods were used to meta-analyze associations. The I2 test was used to assess heterogeneity. RESULTS: The meta-analysis of telomerase shows significantly greater activity in patients with breast cancer than in those without malignancies (OR = 23.46, 95 % CI 14.07-39.11, p < 0.00001, I2 = 72 %). There were non-significant differences in relative telomere length (OR = 1.16, 95 % CI = 0.90-1.49, p = 0.26, I2 = 86 %) and leukocyte telomere length (OR = 2.32, 95 % CI = 0.89-6.08, p = 0.09, I2 = 98 %) between women with and without breast cancer. In subgroup analyses by world regions of studies, both telomerase activity and telomere length displayed the same trends as in their respective meta-analyses. In sensitivity analyses, variables showed their respective same trends. CONCLUSION: Telomerase activity is higher in patients with breast cancer than in women without malignancies. There were no significant differences in either relative telomere length or leukocyte telomere length in women with and without breast cancer. PROSPERO protocol CRD42022335402.

Comparative efficacy of exercise, diet and/or pharmacological interventions on BMI, ovulation, and hormonal profile in reproductive-aged women with overweight or obesity: a systematic review and network meta-analysis.

BACKGROUND: The increasing prevalence of obesity worldwide poses a significant threat to reproductive function owing, in part, to hormonal disturbances caused by negative feedback between excess adiposity and the hypothalamic-pituitary-ovarian axis. Consequently, finding the most appropriate strategies to lose weight and improve ovulation in women with overweight or obesity is a clinically relevant matter that needs to be investigated. A comprehensive comparison of the independent and combined efficacy of lifestyle and/or pharmacological interventions on BMI, ovulation, and hormonal profile in women with overweight or obesity at risk of anovulatory infertility would facilitate improving fertility strategies in this population. OBJECTIVE AND RATIONALE: This study aimed to evaluate the comparative efficacy of exercise, diet, and pharmacological interventions on BMI, ovulation, and hormonal profile in reproductive-aged women with overweight or obesity. SEARCH METHODS: A systematic review was performed by searching PubMed, Scopus, Web of Science, PsycINFO, and Cochrane Library up to 14 December 2023, for randomized controlled trials assessing the effects of exercise, diet and/or pharmacological interventions (i.e. weight-lowering drugs or ovulation inducers) on BMI, ovulation, and/or hormonal profile in reproductive-aged women with overweight or obesity. We performed frequentist random-effect network meta-analyses and rated the certainty of the evidence. The primary outcomes were BMI and ovulation rate, and the secondary outcomes were serum reproductive hormone levels (gonadotrophins, androgens, or oestrogens). We performed sensitivity analyses, including the studies that only involved women with PCOS. OUTCOMES: Among 1190 records screened, 148 full texts were assessed for eligibility resulting in 95 trials (9910 women), of which 53% presented a high or unclear risk of bias. The network meta-analyses revealed that, compared to control: diet combined with weight-lowering drugs (mean difference (MD) -2.61 kg/m2; 95% CI -3.04 to -2.19; τ2 = 0.22) and adding exercise (MD -2.35 kg/m2; 95% CI -2.81 to -1.89; τ2 = 0.22) led to the greatest decrease in BMI; exercise combined with diet and ovulation inducers (risk ratio (RR) 7.15; 95% CI 1.94-26.40; τ2 = 0.07) and exercise combined with diet and weight-lowering drugs (RR 4.80; 95% CI 1.67-13.84; τ2 = 0.07) produced the highest increase in ovulation rate; and exercise combined with diet and weight-lowering drugs was the most effective strategy in reducing testosterone levels (standardized mean difference (SMD) -2.91; 95% CI -4.07 to -1.74; τ2 = 2.25), the third most effective strategy in increasing sex hormone-binding globulin levels (SMD 2.37; 95% CI 0.99-3.76; τ2 = 2.48), and it was coupled with being ranked first in terms of free androgen index reduction (SMD -1.59; 95% CI -3.18 to 0.01; τ2 = 1.91). The surface under the cumulative ranking curve scores suggested that: diet combined with weight-lowering drugs is the strategy most likely (94%) to produce the highest BMI reduction; and exercise combined with diet and ovulation inducers is the strategy most likely (89%) to produce the highest ovulation rate improvement. The sensitivity analyses, which exclusively included studies involving women diagnosed with PCOS, were consistent with the results presented above. WIDER IMPLICATIONS: Overall, the findings of this network meta-analysis indicate that the combination of exercise, diet, and pharmacological interventions is effective for weight loss, improving ovulation, and normalizing the androgen levels of women with overweight or obesity. Although higher quality studies are needed, these results support that the optimal treatment strategy for women with overweight or obesity wishing to conceive must consider exercise, diet, and pharmacological interventions during the shared decision-making process.

KIR gene variability in cutaneous malignant melanoma: influence of KIR2D/HLA-C pairings on disease susceptibility and prognosis.

Natural killer and CD8(+) T cells are believed to be involved in the immune protection against melanoma. Their function may be regulated by a group of receptors defined as killer immunoglobulin-like receptors (KIRs) and their cognate HLA class I ligands. In this study, we analyzed the influence of KIR genes and KIR/HLA-I combinations on melanoma susceptibility and/or prognosis in a Spanish Caucasian population. For this purpose, KIR genotyping by PCR-SSP and HLA-C genotyping by reverse PCR-SSO were performed in 187 melanoma patients and 200 matched controls. We found a significantly low frequency of KIR2DL3 in nodular melanoma (NM) patients (P = 0.001) and in ulcerated melanoma patients (P < 0.0001). Similarly, the KIR2DL3/C1 combination was significantly decreased in melanoma patients (Pc = 0.008) and in patients with sentinel lymph node (SLN) melanoma metastasis (Pc = 0.002). Multivariate logistic regression models showed that KIR2DL3 behaves as a protective marker for NM and ulcerated melanoma (P = 0.02, odds ratio (OR) = 0.14 and P = 0.04, OR = 0.28, respectively), whereas the KIR2DL3/C1 pair acts as a protective marker for melanoma (P = 0.017, OR = 0.54), particularly superficial spreading melanoma (P = 0.02, OR = 0.52), and SLN metastasis (P = 0.0004, OR = 0.14). In contrast, the KIR2DL3(-)/C1C2 genotype seems to be correlated with NM and ulceration. We also report that the KIR2DL1(+)/S1(-)/C2C2 genotype is associated with susceptibility to melanoma and SLN metastasis. Altogether, the study of KIR2D genes and HLA-C ligands may help in assessing cutaneous melanoma risk and prognosis.

Assessment of mammographic density in postmenopausal women during long term hormone replacement therapy.

OBJECTIVE: To assess long-term effects of different hormone replacement therapy (HRT) regimens on mammographic density. METHODS: One hundred sixty-five postmenopausal women were treated with the same HRT during 5 years: 38 received transdermal estradiol, 78 cyclic combined therapy and 49 continuous combined therapy. Mammograms were obtained at baseline, at 1-year and 5-year treatment. Breast density changes were categorized as slight focal increased density, considerable focal increased density, slight diffuse increased density and considerable diffuse increased density. RESULTS: Mammographic density increased in 7.9% of women receiving estrogen alone versus 25.2% of women receiving combined therapy (p < 0.022) during 1 year, and in 7.9% of women versus 28.3% of women (p < 0.009) after 5 years of therapy, respectively. There were significant statistical differences in women treated with estrogen alone versus those treated with combined HRT after 1 and 5 years. After 5 years of HRT, breast density increased 21.8% in women receiving cyclic combined therapy versus 38.8% in those under continuous combined therapy (p < 0.039). CONCLUSION: An increase in breast density is significantly more frequent in women receiving combined estrogen-progestin therapy than in women receiving estrogen alone. There are differences between cyclic and continuous combined therapy at 5 years of treatment.

Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.

INTRODUCTION: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of multiple sclerosis (MS) or relapsing-remitting multiple sclerosis (RRMS; depending on the local label), based on extensive evidence from clinical trials and a real-world setting on efficacy, tolerability and patient-reported benefits. The TERICARE study assessed the impact of teriflunomide treatment over 2 years on health-related quality of life (HRQoL) and some of the most common and disabling symptoms of MS, such as fatigue and depression. METHODS: This prospective observational study in Spain included RRMS patients treated with teriflunomide for ≤ 4 weeks. The following patient-reported outcomes (PROs) were collected at baseline and every 6 months for 2 years: the 29-item Multiple Sclerosis Impact Scale version 2 (MSIS-29), the 21-item Modified Fatigue Impact Scale (MFIS-21), the Beck Depression Inventory (BDI-II), the Short Form (SF)-Qualiveen and the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM). Annualised relapse rate (ARR), disability progression according to the Expanded Disability Status Scale (EDSS), and no evidence of disease activity (NEDA-3) were also assessed. RESULTS: A total of 325 patients were analysed. Patients had a mean (SD) age of 43.2 years (10.4), a mean baseline EDSS score of 1.75 (1.5), a mean number of relapses in the past 2 years of 1.5 (0.7), and 64% had received prior disease-modifying therapy (DMT). Patients showed significant improvements in the psychological domain of MSIS-29 from 35.9 (26.6) at baseline to 29.4 (25.5) at 18 months (p = 0.004) and 29.0 (24.6) at 24 months (p = 0.002). Levels of fatigue and depression were also reduced. After 2 years of treatment with teriflunomide, ARR was reduced to 0.17 (95% CI 0.14-0.21) from the baseline of 0.42 (95% CI 0.38-0.48), representing a 60.1% reduction. Mean EDSS scores remained stable during the study, and 79.9% of patients showed no disability progression. 54.7% of patients achieved NEDA-3 in the first 12 months, which increased to 61.4% during months 12-24. Patients reported increased satisfaction with treatment over the course of the study, regardless of whether they were DMT naive or not. CONCLUSION: Teriflunomide improves psychological aspects of HRQoL and maintains low levels of fatigue and depression. Treatment with teriflunomide over 2 years is effective in reducing ARR and disability progression.

Factors related to insomnia and sleepiness in the late third trimester of pregnancy.

OBJECTIVE: To assess the presence of insomnia and sleepiness and related factors in the late third trimester of pregnancy. METHODS: A total of 370 singleton gravids completed a general questionnaire containing personal data, the Insomnia Severity Index (ISI) and the Epworth Sleepiness Scale (ESS). In addition, maternal anthropometry was recorded upon survey. RESULTS: Median [interquartile range] maternal age and gestational age upon survey was of 31 [7.0] years and 39 [1.8] weeks, respectively. A 73.5% of women displayed some degree of insomnia (Total ISI score 8-28) and 22.2% sleepiness (Total ESS score ≥10). Determined rho Spearman coefficients showed significant correlations between ISI scores and gestational age at survey and survey to birth interval (weeks) and between ESS scores and maternal weight and arm circumference at survey and neonatal birth weight. Multiple linear regression analysis found that smoking habit, higher blood pressure and shorter survey to birth interval (weeks) significantly predicted higher ISI scores, and hence a higher risk of insomnia. Employed status, increased arm circumference and neonatal weight predicted higher ESS scores (sleepiness). CONCLUSION: Insomnia and sleepiness were prevalent in the late third trimester of pregnancy in which lifestyle factors and maternal and neonatal body composition were significant predictors.

Leishmania infantum UBC1 in Metacyclic Promastigotes from Phlebotomus perniciosus, a Vaccine Candidate for Zoonotic Visceral Leishmaniasis.

Leishmania parasites cause outstanding levels of morbidity and mortality in many developing countries in tropical and subtropical regions. Numerous gene expression profiling studies have been performed comparing different Leishmania species' life-cycles and stage forms in regard to their distinct infective ability. Based on expression patterns, homology to human orthologues, in silico HLA-binding predictions, and annotated functions, we were able to select several vaccine candidates which are currently under study. One of these candidates is the Leishmania infantum ubiquitin-conjugating enzyme E2 (LiUBC1), whose relative levels, subcellular location, in vitro infectivity in the U937 myeloid human cell model, and protection levels in Syrian hamsters against L. infantum infection were studied herein. LiUBC1 displays a low level of similarity with the mammalian orthologs and relevant structure differences, such as the C-terminal domain, which is absent in the human ortholog. LiUBC1 is present in highly infective promastigotes. Knock-in parasites overexpressing the enzyme increased their infectivity, according to in vitro experiments. Syrian hamsters immunized with the recombinant LiUBC1 protein did not show any parasite burden in the spleen, unlike the infection control group. The IFN-γ transcript levels in splenocytes were significantly higher in the LiUBC1 immunized group. Therefore, LiUBC1 induced partial protection against L. infantum in the Syrian hamster model.

Body mass index and its correlation to metabolic and hormone parameters in postmenopausal Spanish women.

OBJECTIVE: To assess body weight composition in postmenopausal women and determine correlations with metabolic and hormonal parameters. METHODS: Medical records of 574 postmenopausal Caucasian Spanish women first time attending a menopause clinic were retrospectively reviewed. Retrieved information included general demographic data, type of menopause, time since menopause onset and baseline hormonal and metabolic parameters. A body mass index (BMI) value of >28.8 kg/m(2) was used to define obesity. The metabolic syndrome (METS) was diagnosed with three or more criteria: fasting glycemia ≥ 100 mg/dL, high density lipoprotein cholesterol (HDL-C) <50 mg/dL, triglycerides (TG) ≥ 150 mg/dL, blood pressure ≥ 130/85 mmHg and obesity (as defined above). RESULTS: Mean age of the whole cohort was 49.9 ± 6.1 years, with 66% having a natural menopause. A 38.9% and 23.1% of all women were obese or had the METS, respectively. Obese women were older, had a higher parity, smoked less, had more time since menopause onset and a higher rate of surgical menopause as compared to non-obese ones (p = 0.001). BMI values positively correlated with age, time since menopause, parity, and glucose, TG and systolic blood pressure levels; displaying an inverse correlation with HDL-C and SHBG levels. SHBG levels inversely correlated with glucose, TG, HDL-C and systolic blood pressure levels. CONCLUSION: In this Spanish postmenopausal population BMI significantly increased with age, time since menopause and parity displaying significant correlations with hormonal and metabolic parameters.

First trimester serum levels of 25-hydroxyvitamin D, free ß-human chorionic gonadotropin, and pregnancy-associated plasma protein A in Spanish women.

BACKGROUND: Vitamin D has been implicated in embryo/placental development and growth; however information in this regard is limited or unavailable. OBJECTIVE: To assess 25-hydroxyvitamin D (25(OH)D), free ß-human chorionic gonadotropin (ß-hCG) and pregnancy associated plasma protein A (PAPP-A) status during pregnancy. METHODS: Serum 25(OH)D, ß-hCG, and PAPP-A levels were measured in the first trimester of otherwise healthy Spanish pregnant women (n=488). Rho Spearman coefficients were calculated to determine correlations between analytes. RESULTS: Median serum 25(OH)D levels for the entire sample was 27.4 ng/ml (interquartile range=12.1). 25(OH)D levels were insufficient (20-29.99 ng/ml) and deficient (<20 ng/ml) in 40.6% and 23.2%, respectively, in relation to ethnics, body mass index values, tobacco use, and season/gestational age at blood sampling. ß-hCG and PAPP-A levels significantly correlated (r²=0.47) yet neither of them with 25(OH)D levels. Despite this, the three analytes significantly correlated with gestational age at sampling. CONCLUSION: First trimester 25(OH)D, ß-hCG, and PAPP-A levels increase with gestational age; however, placental peptides do not correlate with vitamin D levels, suggesting a non-placental 25(OH)D production. More research is required in this regard.

Metabolic and hormonal parameters in post-menopausal women 10 years after transdermal oestradiol treatment, alone or combined to micronized oral progesterone.

BACKGROUND: In the post-Women's Health Initiative Study era few post-menopausal women complete long term hormonal treatment (HT). OBJECTIVE: To analyse metabolic/hormonal parameters and frequency of the metabolic syndrome (METS) in post-menopausal women after 10 years of HT. METHODS: Retrospective data from parallel cohorts of post-menopausal women receiving HT for 10 years was analysed. Regimens included: transdermal oestradiol (50 microg) (n=22), sequential cyclic HT with transdermal oestradiol (50 microg) plus 200 mg/day micronized oral progesterone (cycle days 12-25) (n=83), or continuous combined HT with transdermal oestradiol (50 microg) plus 100 mg/day micronized oral progesterone (n=46). A group of women who elected not to use HT served as a control group (n=35). RESULTS: Frequency of the METS did not significantly increase after 10 years of HT. Oestradiol and sex hormone binding globulin (SHBG) levels displayed a significant increase compared to baseline after 10 years of HT (all regimens). These values were significant higher when compared to the control group. Glucose levels were significantly higher after 10 years in women receiving the sequential cyclic regimen. Although not reaching statistical significance, there was a trend for transdermal oestradiol alone to increase HDL-C and decrease triglyceride levels. CONCLUSION: Serum oestradiol and SHBG levels were significantly higher after 10 years of transdermal oestradiol, alone or combined with micronized oral progesterone, without differences observed in serum metabolic parameters. More research through randomised clinical trials is required.

Lack of correlation between first trimester maternal serum 25-hydroxyvitamin D levels and ultrasound measured crown-rump length and nuchal translucency.

BACKGROUND: Vitamin D regulates the human genome and it is thought to influence the fetal growth and development, but its relation to early ultrasound fetal measures is still unknown. OBJECTIVE: To assess first trimester 25-hydroxyvitamin D [25(OH)D] maternal serum status and correlate with ultrasound crown-rump length (CRL) and nuchal translucency (NT) measurements. METHOD: In this cross-sectional study, women with singleton pregnancies undergoing the first trimester standard two-dimensional ultrasound scan for fetal anomalies were included: CRL (n = 498) and NT (n = 487). Concomitantly, maternal serum 25(OH)D levels were also measured. RESULTS: Median serum 25(OH)D levels for the entire sample (n = 498) was 27.4 ng/mL (interquartile range 20.9-32.7). Serum 25(OH)D was adequate (≥ 30 ng/mL) in only 36.1% of gravids, whereas levels were found to be insufficient (20-29.99 ng/mL) in 41.2% and deficient (< 20 ng/mL) in 22.7%. No significant correlation was found between the serum 25(OH)D levels and the measured ultrasound parameters. CONCLUSION: First trimester 25(OH)D levels did not correlate to fetal ultrasound measurements.

Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial.

BACKGROUND: Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies. PURPOSE: The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity. MATERIAL AND METHODS: The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7-14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery. CONCLUSION: The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery. TRIAL REGISTRATION: EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018.

Assessing fatal cardiovascular disease risk with the SCORE (Systematic Coronary Risk Evaluation) scale in post-menopausal women 10 years after different hormone treatment regimens.

OBJECTIVE: To assess fatal cardiovascular disease (FCD) risk among women in early post-menopausal years, as evaluated with the Systematic Coronary Risk Evaluation (SCORE) scale. DESIGN: This was a retrospective study of parallel cohorts. Two hundred seventy-three healthy post-menopausal women. Participants received one of the following hormone treatment (HT) regimens: transdermal estradiol (50 microg) (n = 99), sequential cyclic HT with transdermal estradiol (50 microg/day) plus 200 mg/day natural micronised oral progesterone (cycle days 12-25) (n = 63) and combined HT using transdermal estradiol (50 microg) plus 100 mg/day of micronised oral progesterone (n = 61). A group of women who elected not to use HT served as control group (n = 50). SCORE values were assessed before HT or follow up. RESULTS: Only one woman displayed a high-risk SCORE value both before and after 10 years of HT, the remaining had low risk values (<5%) for FCD. After 10 years, SCORE values increased significantly as compared to baseline among HT users (all three regimens) and controls. Although post-treatment SCORE values significantly differed among groups, values were all below the high risk cut-off (5%). There were no FCD events during the 10 year observation period. CONCLUSION: As assessed with the SCORE scale, FCD risk in young post-menopausal women (HT users and controls) had a slight significant increase after 10 years, being values in the low risk range.

Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant).

BACKGROUND: Severe and morbid obesity are increasing globally, particularly in women. As BMI increases, the likelihood of anovulation is higher. The primary aim of the EMOVAR clinical trial is to examine, over the short (16 weeks) and medium (12 months) term, the effects of a supervised physical exercise program (focused primarily on aerobic and resistance training) on ovarian function in women with severe/morbid obesity who have undergone bariatric surgery. Secondary objectives are to examine the effects of the intervention on chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life. METHODS: This is a randomized controlled trial in which ∼40 female bariatric surgery patients, aged between 18 and 45 years old, will be included. Participants assigned to the experimental group will perform a total of 48 sessions of supervised concurrent (strength and aerobic) training (3 sessions/week, 60 min/session) spread over 16 weeks. Patients assigned to the control group will receive lifestyle recommendations. Outcomes will be assessed at baseline, week 16 (i.e., after the exercise intervention) and 12 months after surgery. The primary outcome is ovarian function using the Sex-Hormone Binding Globuline, measured in serum. Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale). Other secondary outcomes include serum markers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and the HOMA-IR), arterial stiffness, systolic, diastolic and mean blood pressure, body composition, and total weight loss. Physical fitness (including cardiorespiratory fitness, muscular strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index) will also be measured. DISCUSSION: This study will provide, for the first time, relevant information on the effects of exercise training on ovarian function and underlying mechanisms in severe/morbid obese women following bariatric surgery. TRIAL REGISTRATION NUMBER: ISRCTN registry (ISRCTN27697878).