Given the prevalence of infertility and consequences of stress, anxiety, and depression during pregnancy and after childbirth, this study aimed to determine the effect of group cognitive behavioral therapy (CBT)-based counseling on perceived stress (primary outcome), anxiety, depression, and quality of life (QoL) of pregnant women with a history of primary infertility.n = 28) and control (n = 28) groups using block randomization. The intervention group received group CBT-based counseling after the 14th week of the pregnancy: six in-person sessions and two telephone sessions once per week. The control group received routine care. The Perceived Stress Scale (PSS), Edinburgh Postnatal Depression Scale (EPDS), Van den Bergh’s Pregnancy-Related Anxiety Questionnaire (PRAQ), and Quality of Life in Pregnancy (Gravidarum) (QOL-GRAV) were completed through interviews before and 4 weeks after the intervention by the researcher.This controlled randomized clinical trial was conducted on 56 pregnant women with a history of primary infertility referred to Infertility Clinic of Al-Zahra Teaching Hospital of Tabriz. The participants were divided into the intervention (p > 0.05). Both of these variables were adjusted in ANCOVA. After the intervention, the mean scores of perceived stress  and anxiety  were significantly lower in the intervention group. The mean depression score in the intervention group was lower than the control; however, this between-group difference was not significant . The mean score of quality of life in pregnancy was significantly higher in the intervention group than the control .There was not any between-group difference in socio-demographic characteristics, except the gestational age and husband educational level (CBT counseling can affect the perceived stress, anxiety, and quality of life of pregnant women with a history of primary infertility. As a result, this counseling approach is recommended along with other counseling approaches to improve the mental health of pregnant women with a history of infertility.IRCT20111219008459N12, registered on 10/11/ 2018.IRCT Registration Number:  Infertility is defined as the inability to become pregnant after one year of unprotected coitus . AcordinStress is defined as an organism’s total response to environmental demands or pressures which is perceived as a threat to their abilities and resources and endangers their health . Stress Different studies have recommended several psychological interventions, including Cognitive Behavioral Therapy (CBT) to improve depression and anxiety , 14. CBTLoGiudice et al. 2018) performed a systematic review to investigate the effect of complementary therapies on psychological factors in women undergoing IVF and observed their effectiveness in reducing anxiety, depression, and stress, and improving quality of life during pregnancy . Klerk e performeTaking into account the anxiety and stress in pregnant women with a history of infertility , their aThis controlled randomized clinical trial was conducted on 56 pregnant women aged between 20 and 40 years old with a history of primary infertility referred to Infertility Clinic of Al-Zahra in Tabriz, Iran. Sampling was conducted from November 2018 to June 2019. Inclusion criteria were age range between 20 and 40 years, history of primary infertility, at least secondary school educational level, and gestational age between 14 to 20 weeks. Exclusion criteria were fetal abnormality, self-reported history of mental illnesses, chronic physical diseases and experience of unfortunate events in the past 3 months (e.g. relative loss).Sampling was initiated after obtaining an ethics code from the Ethics Committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1397.625) and registering the study on the Iranian Registry of Clinical Trials (IRCT20111219008459N12) website. The researcher attended the Al-Zahra Teaching Hospital of Tabriz and extracted the list of women impregnated by assisted reproduction technologies (ART). Then, they were called and provided with a brief description of research objectives and methodology. Eligibility of the samples was assessed and eligible women who were willing to participate in the study were invited. In an in-person meeting, research objectives and methodology were completely explained. Women impregnated with ART, were interviewed and their Perceived Stress Scale (PSS) was completed by the author. The participants scored higher than the cut-off point of 21.8 (high level of stress) were included and their informed written consent was obtained. Then, the Postnatal Depression Scale (PDS), Pregnancy-Related Anxiety Questionnaire (PRAQ), and Quality of Life in Pregnancy (QOL-GRAV) were completed by the researcher through interviews.The participants were divided into the intervention and control groups using block randomization with blocks of 4 and 6, based on the age range (20–30 and 30–40 years). For allocation concealment, the type of intervention was written on a piece of paper by a person not involved in sampling and data analysis. Papers were then enclosed in specific envelopes numbered sequentially. Each participant received an envelope on arrival.First session: Inducting, determining the number and duration of each session, sequence of sessions and group regulations, identifying problem, introducing CBT, introducing cognitive-behavioral pattern, describing the problem based on the given pattern, determining objectives, and receiving feedback.Second session: Conducting mood assessment, describing problem based on the given pattern, impacts of lack of control on stress process, determining objectives, introducing progressive muscle relaxation and practicing it, and allocating homework assignments: planning for progressive muscle relaxation twice per day and receiving feedback.Third session: Conducting mood assessment, reviewing progressive muscle relaxation, asking participants to pose problems, introducing imagination and practicing it , and allocating homework assignments: practicing progressive muscle relaxation and imagination, and receiving feedback.Fourth session: Conducting mood assessment, reviewing imagination practices, introducing three first columns of thought record sheet , introducing hot thought concept, practicing three columns  using one event happened last week, and allocating homework assignments: imagination technique and three first columns of the thought record sheet, receiving feedback.Fifth session: Conducting mood assessment, conducting discussion about treatment process and its completion, reviewing homework assignments, introducing cognitive distortions, completing three columns of thought record sheet , identifying hot thought, introducing the concept of hot thought challenge, and determining homework assignments: relaxation technique and recording three columns of the thought record sheet  and receiving feedback.Sixth session: Conducting mood assessment, reviewing homework assignments, introducing challenge with thoughts and 7-column thought record sheet , completing columns during the session, introducing the concept of hot thought challenge, allocating homework assignments: recording three first columns of the though record sheet and relaxation techniques, receiving feedback.Seventh session: Conducting mood assessment, reviewing homework assignments, completing seven columns of the thought record sheet during the session , and allocating homework assignments: completing 7-column thought record sheet and relaxation techniques, receiving feedback.Eighth session: Conducting mood assessment, reviewing homework assignments, reviewing the treatment process (reviewing and recording different CBT techniques), taking recurrence prevention process, introducing self-management sessions and its scheduling, and allocating homework assignments: self-management session and determination of the precise date of post-test.The intervention group, comprised of 5–7 participants, received six 60- to 90-min in-person CBT sessions in a quiet and friendly room in the Infertility Clinic of Al-Zahra Teaching Hospital and two telephone sessions once a week by the researcher. The CBT sessions was conducted by a graduate student in midwifery counseling under the supervision of a PhD in clinical psychology who designed the intervention procedure. The intervention was supervised by two person who not involved in the study approximately once every two weeks randomly. For encouraging the eligible women to participate in the study, the importance of psychotherapy and its role in improving the outcome of pregnancy were explained during the recruitment stage of study and after confirming their desire to participate in the study and counseling sessions, they were entered to the study. The day before each counseling session, the time of the session was reminded with telephone call and the motivation to participation in the session was strengthened again. In case of non-participation of any person in any meeting, she was invited to another group to hold the same meeting during the same week, therefore, All 28 members of the intervention group completed all counseling sessions. In addition, the counseling was provided in participants’ native language. A brief explanation of the content of the sessions is as follows .First sThe control group only received routine pregnancy care based on the “National Guideline for Midwifery and Delivery Services” of Iran . Four weData were collected using the socio-demographic and midwifery scale, Cohen’s perceived stress scale, PRAQ, EPDS, QOL-GRAV.The socio-demographic and midwifery questionnaire was prepared by the authors and its validity was confirmed by 10 academic members of Tabriz University of Medical Sciences.The degree of stress (primary outcome) was measured using PSS-14. The scale is scored based on a 5-point Likert scale; the lowest and highest scores are 0 and 56, respectively. The cut-off point was 21.8 and a higher score indicated a higher degree of stress. The internal consistency and reliability coefficients were obtained through Cronbach’s alpha in a range of 0.84–0.86 in two groups of students and a group of tobacco users in a smoking cessation program . The relThe shortened version of the PRAQ (PRAQ-17) which was used to measure the anxiety level (secondary outcome), contains 17 items and the score of each item ranges between 1 and 7. Therefore, the total PRAQ score is between 17 and 119. The higher total PRAQ score indicates a higher level of anxiety .This scale is used to measure the level of depression (secondary outcome) during pregnancy and postpartum. Items are scored from 0 to 3 based on the severity of symptoms. An individual’s score is the total sum of all 10 items, which varies between 0 and 30. Mothers who scored higher than the threshold level  had diffThis questionnaire was developed by Vachkova et al. (2013) using the WHO Quality of Life-BREF (WHOQOL-BREF). It is composed of 9 items to measure individuals’ experience of the quality of life during pregnancy (secondary outcome). The QOL-GRAV’s score varies between 9 and 63. Higher scores indicate a higher quality of life . MirghafIn the present study, the reliability of the questionnaire was determined through test-retest on 20 women in a two-week interval and the Cronbach’s alpha and intraclass correlation coefficient (ICC) was determined. The ICC for PSS, PRAQ, EPDS, and QOL-GRAV was 0.91, 0.88, 0.83, and 0.93, respectively. The Cronbach’s alpha for these questionnaires was 0.87, 0.78, 0.72, and 0.91, respectively.Existence of any adverse event after the intervention was asked from participants as an open question after completing the post-test questionnaires.d = (M2 - M1) / SDpooled. All analyses were done based on intention-to treat.After collecting data from all participants, they were analyzed in SPSS-21. The normality of the quantitative data was determined using the Kolmogorov-Smirnov Test and all variables were normal. The chi-square test, Trend chi-square test, Fisher’s exact test, and independent t-test were used to assess the consistency of socio-demographic data. The independent t-test was used to compare the two groups before intervention in terms of perceived stress, anxiety, depression, and quality of life. After the completion of the intervention, this comparison was conducted using the analysis of covariance (ANCOVA) while controlling the baseline values and the effect size was calculated based on this formula: Cohen’s Sample size estimation in G-Power was 24 per group based on the study by Hassan-Zadeh Lifshagerd , considen = 56) and they were equally randomized into counseling and control groups. Because the participants were motivated enough by the researcher, all 28 participants of the intervention group completed all counseling sessions, they also did their homework in more than 90% of the cases. Due to premature birth, two participants in the counseling group and three participants in the control group were excluded. As a result, the post-intervention follow-up analysis was conducted with 26 participants in the counseling group and 25 participants in the control group .The comparison of socio-demographic characteristics of participants in study groups was shown in Table p = 0.561). Based on the ANCOVA and adjusted baseline values, the mean ± standard deviation of the total perceived stress score was significantly lower in the counseling group than that of control group after intervention   Table , correspp = 0.484), whereas based on the ANCOVA and adjusted baseline values, the mean ± standard deviation of total anxiety score was significantly lower in the counseling group than that of control group after intervention  . After intervention, based on the ANCOVA and adjusted baseline values, the mean ± standard deviation of depression was lower in the counseling group than that of control group; however, this between-group difference was not significant  . After intervention based on the ANCOVA and adjusted baseline values, the mean ± standard deviation of the total quality of life score was significantly higher in the counseling group than that of control group   Table , correspNo adverse events were reported by participants.Results from this study showed that the mean perceived stress and anxiety scores were significantly lower in the counseling group than the control 4 weeks after intervention. The mean depression score was lower in the control group 4 weeks after intervention with adjusted baseline values; however, this between-group difference was not significant. Moreover, the mean quality of life score was significantly higher in the counseling group than the control.In a review study, Ying et al. (2016) investigated the effect of psychological interventions on mental health, pregnancy rate, and marital function of infertile couples undergoing IVF. In 20 trials under investigation, 14 interventions, such as CBT, mindfulness, counseling, coping with stress, and positive reassessment used at different IVF stages were studied. The authors concluded that none of these interventions were effective in soothing stress and depression of patients undergoing IVF . ResultsGiven that stress perception and responding to it are affected by previous experiences, the present situation and learned behaviors , it coulp < 0.001). In addition, group CBT was more effective than interactive lectures in reducing participants anxiety; however, this between-group difference was not significant (p > 0.05) [Hamzeh Poor (2014) showed that anxiety in infertile women was significantly lower in the CBT group than the control . Finding > 0.05) . ResultsP < 0.001); But it had no significant effect on depression [p = 0.104). Moreover, anxiety score in the CBT group was significantly lower than that of EFT group (p = 0.032) [In a review and meta-analysis study, Golshani et al. (2020) examined the effect of cognitive-behavioral therapy on anxiety and depression in Iranian infertile women and concluded that the level of anxiety in infertile women who received cognitive-behavioral therapy compared to the control group was significantly lower (pression . The respression . The respression . Chatwin= 0.032) .According to the cognitive-behavioral theory, anxiety disorders are caused by mistaken beliefs, which affect the interpretation of events and induce a disproportionate emotional response . As a rep < 0.01) [p < 0.05) [In this study, cognitive-behavior counseling improved the quality of life of pregnant women with a history of primary infertility. In the review of literature, the author found no relevant study on pregnant women. In a controlled randomized clinical trial, Cooney et al. (2018) investigated the effect of CBT on weight and quality of life of women with polycystic ovary syndrome (PCOS). Results showed that weekly CBT + LS (lifestyle) for 8 weeks was more effective than LS alone in reducing weight and improving the quality of life in women with PCOS . In a qu < 0.01) . In a cl < 0.05) . Results, while the most of previous studies were either about CBT-based counseling in pregnant women with no history of infertility or were about the impact of this type of counseling on the mental health of infertile women during infertility treatment before getting pregnancy test results and in some studies the target population was quite different, which should be considered in comparing the results.All participants in this study were first-time pregnant women with a history of primary infertility and were literateThe financial burden from infertility treatment, lengthy treatment period, irrational thoughts about having a child, psychological pressures from relatives, and low educational level are among factors having adverse effects on the quality of life of infertile women . Women iIn addition to the positive effects mentioned for CBT, because this method is done in a group, it also has the benefits of group therapy. In this way, people see themselves as part of a group that has had similar experiences; As a result, they know that what happened to them is common and they are not alone. Group members help each other by exchanging information. Sharing feelings and experiences with a group of people helps to relieve feelings of pain, guilt or stress and causes emotional relief.In the present study, all responses of participants were assumed to be correct as their validation was beyond the researchers’ ability. Moreover, this study was a small study in one center and all participants were literate with history of primary infertility, which could affect generalizability of the results, therefore, the results should be generalized with caution. Among the strengths of this study are observing all principles of clinical trials, including allocation randomization and allocation concealment, completion of the questionnaire by the researcher, and reduction of plausible incomplete, null, and wrong responses. To make a better communication with the participants, their native language was used during the counseling sessions.According to the results, CBT-based group counseling is effective in reducing perceived stress and anxiety, and improving quality of life. Given the needs of pregnant women with a history of primary infertility for both psychical and psychological supports to improve pregnancy outcomes, mental health, and quality of life, healthcare providers can provide them with this counseling technique, along with routine pregnancy care.


Background: The prevalence of high serum uric acid is increasingly rising in recent years, and diet behavior is perceived to be associated with it. This study aimed to explore the relationship between eating away from home (EAFH) and the risk of high serum uric acid in adults in South China.Methods: The data utilized in this study were from Guangdong Nutrition and Health Survey (NHS) 2015. Serum uric acid concentration was detected. EAFH in the past week was investigated. We defined EAFH as food consumption away from home. Dietary data were collected by 24-h recalls on 3 consecutive days. A generalized linear mixed-effects model was applied to compute the odds ratio (OR) and its corresponding 95% CI.Results: A total of 3,489 individuals were included in this study. A 1.27-fold OR  of high serum uric acid was identified in adults with EAFH in comparison with those without EAFH. With respect to men, a 1.66-fold OR  of high serum uric acid was observed. We also observed that men with EAFH had higher intakes of red meat, poultry, vegetable, carbohydrate, protein, fat, and total energy, while a lower grain intake than those without EAFH. However, there was a lack of significant association between EAFH and the odds ratio of high serum uric acid in women. Women with EAFH did not have higher consumptions of red meat, vegetable, fish, fat, and water than those without EAFH.Conclusions: This study found that EAFH was associated with an increased odds ratio of high serum uric acid in men, but not in women. Hyperuricemia is perceived as a diet-related disease, which is characterized as the abnormal metabolism of purine . AccordiRisk factors for hyperuricemia include age, sex, genetics, lifestyle, and environmental quality , 10. PreGuangdong province is located in South China and its economy has a rapid development since the reform and opening-up. Diet patterns and food sources in local citizens have dramatically changed in the last few decades. According to some recent studies, animal-derived foods account for an increasing proportion of the total caloric intake in this population , 21. AloData utilized in this study were derived from Guangdong Nutrition and Health Survey (NHS) 2015, which was cross-sectional designed and a part of Chinese NHS 2015 . NHS wasTo obtain a minimum sample size in each county, the following formula was applied:where N is the sample size, deff is design efficiency and set to be 3, u is the dividing value of normal distribution and set to be 1.96, p is probability and set to be 9.7% , and d is deviation and set to be 0.0196 (20% × 9.7%). Thus, at least 612 adults were needed in each county.A total of 8,991 adults were recruited in Guangdong NHS and 3,643 adults finished the food consumption survey. Since 157 participants lacked complete information, a total of 3,489 adults were included in this study.Individual dietary data were collected by three consecutive 24-h recalls, 2 weekdays, and 1 weekend. Dietary assessment was performed by well-trained staff through face-to-face interviews and household surveys. All kinds of food and taking amount by participants in the 3 days were recorded. Food weight was evaluated by the investigator according to the recall of participants and with the help of a food map, comparison with the container, etc. Since cooking oil and condiments were consumed by family members at the household, we recorded their consumption amount at the household level. And then individual consumption of cooking oil and condiments was calculated based on the individual ratio of energy intake among family members and the times of taking meals at home. Major nutrients intake, including carbohydrate, protein, and fat, as well as total energy intake, were calculated according to the Chinese Food Composition Tables (2004 and 2009) .The dining places of participants in the past week were investigated. We defined EAFH as food consumption away from home in this study. In order to explore the combined effect of EAFH on high serum uric acid, adults who had more than one meal  EAFH (restaurant and/or company/school canteen) in the past week were perceived as having a habit of eating outside.2). Definition of hypertension was based on guidelines of the World Health Organization (WHO) (Anthropometric measurements were performed by well-trained investigators. Weight (kg), height (m), systolic blood pressure (mmHg), and diastolic blood pressure (mmHg) were measured, and their procedures were described elsewhere . Electroon (WHO) .The blood sample was collected from each participant in the morning after fasting for at least 8 h. The serum sample was separated after centrifugation. Serum uric acid concentration was determined by the oxidase method on an automated analyzer . Since serum uric acid was measured only once and serum sample from another day was no longer available, adults with hyperuricemia cannot be confirmed. Thus, we applied high serum uric acid to describe the abnormally high level of serum uric acid and it was defined as serum uric acid >420 μmol/L in men, while >360 μmol/L in women according to the definition of hyperuricemia in a previous study . Additiot-test or Kruskal Wallis test was employed.Continuous variables were exhibited as mean and standard deviation if they were normal distribution, or exhibited as median and quartile if they were skewed distribution. Discrete variables were exhibited as number and proportion. To compare the differences of continuous variables  between two groups (EAFH and non-EAFH), Student's To explore the association between EAFH and the odds ratio of high serum uric acid, a generalized linear mixed-effects model was used and crude odds ratio (OR) and its corresponding 95% confidence interval (CI) were computed, as described in a previous study . We put To obtain a robust association between EAFH and the odds ratio of high serum uric acid, subgroup analysis stratified by different sexes (men and women), meals , and dining out places (restaurant and canteen) were performed. Possible confounding effects mentioned previously were also adjusted applying different models.p-value < 0.05 was characterized as statistically significant.Statistical analysis in the present study was performed in SAS Enterprise Guide  and R version 3.5.1 . A A total of 3,489 adults with an average age of 52.0 ± 14.9 years were included in this study. Men accounted for 45.9% . The mean of serum uric acid was 342.4 ± 94.9 umol/L in the total sample, 385.9 ± 91.9 umol/L in men, and 305.3 ± 80.7 umol/L in women. The frequency of EAFH was 19.9%  in the total sample, 23.6%  in men, and 16.9 %  in women. The proportion of high serum uric acid was 26.4%  in the total sample, 32.5%  in men, and 21.2%  in women. Additional information about included participants is exhibited in P = 0.012) of high serum uric acid was found in participants who had a habit of EAFH. The positive association remains after adjusting for age  or age and sex , while the association was not statistically significant after adjusting for sex  or multifactor . Detail results are shown in A 1.27-fold OR , adjusting for age , or adjusting for multifactor . However, as for women, the associations were not statistically significant  was higher than in women (16.9%) in our study. This may be explained by sex differences in family responsibilities. In China, most women should take the responsibility of taking care of the family, which would reduce the frequency of EAFH , 28. FurSeveral limitations in this study should be discussed. Firstly, although this study was based on a large sample size of 3,489 individuals, the extrapolated conclusion should limit to the adult as only participants over 18 years old were eligible. High serum uric acid is more prevalent in middle-aged adults than young-aged adults or children and adolescents. We did not analyze the different effects regarding various age groups for spatial confined. Secondly, it should be noted that a cross-sectional study cannot draw a causal relationship because of the indeterminately chronological order of the relation and potential confounding factors. We employed a generalized linear mixed-effects model and put possible risk factors into the model as we could to adjust their potential confounding effects. However, effects from other possible risk factors such as family history and co-existing diseases, cannot be eliminated. Thirdly, we did not analyze the effect of consuming takeaway food on high serum uric acid, which might introduce potential misclassification bias. As the rate of consuming takeaway food is increasingly rising, its impact on diet-related disease should be uncovered and further studies are warranted. Fourthly, serum uric acid would be affected by dietary factors with a medium to a long period, while we only applied 3 consecutive 24-h recalls collecting food consumption, which only provided clues to the cause of high serum uric acid. The association between medium or long-term EAHF and the OR of high serum uric acid should be verified.This study demonstrated an increased OR of high serum uric acid in adults with EAFH in 3,489 individuals who participated in Guangdong NHS in South China. Sex differences in the association were observed. Compared with those without EAFH, a 1.66-fold OR of high serum uric acid was found in men with EAFH, while the association was not statistically significant in women. We also found sex differences in food intake between EAFH and non-EAFH. Diet behavior has a close link to diet-related diseases and good diet behaviors should be publicly advocated to promote their health.The original contributions presented in the study are included in the article/The studies involving human participants were reviewed and approved by the Ethical Committee of Chinese Center for Disease Control and Prevention. The patients/participants provided their written informed consent to participate in this study.J-wP and Z-hC conceived and designed the experiments. S-wC and PW performed the analyses. S-wC wrote the first draft of the manuscript. PW, G-yJ, QJ, X-mH, W-jM, and RH significantly contributed to the development of the final draft of the manuscript. All authors approve of the final version of the manuscript.This study was supported by Guangdong key research and development program  and Guangdong mandatory medical research fund project (Grant No.: C2019050).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Background: Preventing suicide among adolescents is an urgent global public-health challenge, especially in Africa. Accordingly, the aim of this study was to examine the relationship between the early initiation (< 12 years old) of substance use  and attempted suicide among in-school adolescents in seven African countries.Methods: Data on the early initiation of substance use and on attempted suicide among in-school adolescents over the previous 12 months in Benin, Liberia, Mauritius, Mozambique, Namibia, Seychelles, and the United Republic of Tanzania were collected from Global School-based Student Health Surveys and were pooled to determine the overall prevalence of these behaviors in adolescents. Univariate and multivariate logistic regressions were then performed to evaluate country-specific associations between the early initiation of substance use and attempted suicide in these adolescents, followed by meta-analyses to evaluate overall pooled associations.Results: In the abovementioned seven African low- or middle-income countries (LMICs), overall weighted prevalences of attempted suicide and early initiation of cigarette smoking, alcohol use, and drug use among in-school adolescents were 16.05, 7.76, 17.68, and 3.48%, respectively. Multivariate logistic regression analyses revealed that relative to non-smoking, the early initiation of smoking was significantly associated with attempted suicide in these adolescents [OR (95% CI) = 1.783 (1.219–2.348)]. Additionally, the relationship between early initiation of cigarette smoking and attempted suicide is mostly driven by a higher association in girls [OR (95% CI) = 1.867 (1.031–2.703)] than boys [OR (95% CI) = 1.392 (0.995−1.789)]. Moreover, relative to not using other drugs, the early and later initiation of other drug use were also significantly associated with attempted suicide in these adolescents [ORs (95% CIs) = 2.455 (1.701–3.208) and 1.548 (1.198–1.898)].Conclusion: Programs that can eliminate or decrease the early initiation of substance use among adolescents should be implemented in African LMICs to prevent subsequent suicide attempts, especially among adolescent girls. The prevention of adolescent suicide is an urgent global public-health challenge . In 2016Africa has the world’s largest population of children, and the world’s second-largest population of adolescents . ApproxiSubstance use, such as smoking cigarettes, drinking alcohol, and using drugs, is strongly associated with attempted and completed suicide . RecentlThe reported associations between these dramatically increased risks of attempted suicide in adolescents and the early initiation of substance use are consistent and unambiguous, yet the specific mechanisms underlying these associations remain unclear. It may be that the early initiation of substance use by adolescents is due to a complex interaction between developmental, psychological, and sociocultural factors, which jointly increase the risk of attempted suicide . In addiHowever, little is known about the relationship between the early initiation of substance use and attempted suicide in Africa, which has the world’s highest rate of attempted suicide in adolescents . TherefoThe data used for this study were obtained from the publicly available datasets of the Global School-based Student Health Survey (GSHS), which is a self-administered, school-based multi-country survey that has been conducted in LMICs and was jointly developed by the World Health Organization (WHO) and the United States Centers for Diseases Control and Prevention (CDC) . The GSHThe data used for this study were collected via a self-reported questionnaire, which was translated into the local language of each LMIC and completed by students on a computer-scannable form during regular class time. The details of measures pertaining to this analysis are detailed in I2 statistic to estimate between-country heterogeneity. A between-country heterogeneity value of < 25% was considered to indicate negligible heterogeneity, and relevant data were thus subjected to a fixed-effects meta-analysis;. We added weights, strata, and a primary sampling unit to every set of school-attending adolescents to reflect the weighting process and the two-stage sampling design. We also used univariate logistic regression models to analyze the weighted relationships in each African LMIC between the early initiation of substance use, confounding factors, and attempted suicide, and then adjusted for confounding factors in multivariate logistic regression models to explore the relationships between the early initiation of substance use and attempted suicide. We calculated pooled overall estimates by fixed-/random-effects meta-analysis using STATA , and used the Higgins’s analysis; whereas I2 were greater than 75%  were higher than those who had not smoked 13.49%, . The preThe early initiation of cigarette smoking, alcohol use, and other drug use (< 12 and ≥ 12 years old) were all significantly associated with attempted suicide in adolescents. Current cigarette smoking, alcohol use, drug use, insufficient food, having a physical fight, and being bullied were also significantly associated with attempted suicide. Furthermore, psychological distress and parental support were also significantly associated with attempted suicide, and the magnitude of these associations increased with the number of items .Multivariate logistic regression analyses revealed that relative to non-smokers, the early initiation of cigarette smoking in adolescents was significantly associated with attempted suicide [OR (95% CI) = 1.783 (1.219–2.348)]. However, the early initiation of alcohol use was not significantly associated with attempted suicide [OR (95% CI) = 1.168 (0.832–1.503)]. The early and later initiation of drug use were also significantly associated with attempted suicide , and there was a significant association between the early initiation of drug use and attempted suicide in both adolescent girls and boys [ORs (95% CIs) = 2.446 (1.299–3.593) and 2.094 (1.258–2.931)]. Additionally, the relationship between early initiation of cigarette smoking and attempted suicide is mostly driven by a higher association in girls [OR (95% CI) = 1.867 (1.031–2.703)] than boys [OR (95% CI) = 1.392 (0.995−1.789)] .Our findings demonstrated robust associations between the early initiation of cigarette smoking and drug use and self-reported attempted suicide in adolescents in Africa. The OR of self-reported attempted suicide in adolescents who were early initiators of cigarette smoking was 1.783 times that of adolescents who did not smoke. The relationship between early initiation of cigarette smoking and attempted suicide is mostly driven by a higher association in girls than boys. The OR of self-reported attempted suicide in adolescents who were early initiators of other drug use was 2.455 times that in those who did not use other drugs. However, the early initiation of alcohol use was not associated with self-reported attempted suicide.The prevalences of the early initiation of cigarette smoking and other drug use in African adolescents were 7.8 and 3.5%, respectively, which was less than the prevalences that have been reported in previous studies of adolescents in Pacific Island countries (15.7 and 12.9%) , South-EIn our univariate analysis, experience hungry, having a physical fight, be bullied, psychological distress, parental support, current substance use were all associated with self-reported attempted suicide, which were contrast to previous studies , and theThe reasons for the above-mentioned differences between our findings and those of previous studies remain unclear, but there are several reasons that may account for the lack of an association between the early initiation of alcohol use and attempted suicide. First, although the early initiation of substance use typically harms the developing brains of adolescents , it was In contrast, we found that the early initiation of cigarette smoking was not associated with attempted suicide in adolescent boys, which was consistent with the results from studies in South Korea , and in In our previous study, we highlighted the extremely high prevalence of suicidal behaviors in African adolescents , and theHowever, there are several limitations to our study. First, the data from the GSHS are obtained via self-report, and thus, recall bias was inevitable. However, the GSHS questionnaire was validated by expert consultation , and thuWe found that there was a high rate of early initiation of substance use  and a high prevalence of attempted suicide among in-school adolescents in seven LMICs in Africa, and that the early initiation of cigarette smoking and drug use were associated with attempted suicide. Thus, it is critical that programs be developed to reduce or prevent the early initiation of substance use among adolescents in African, as this will decrease the possibility of them attempting suicide.www.who.int/ncds/surveillance/gshs/en/.Publicly available datasets were analyzed in this study. This data can be found here: LL, YZ, MS, and YW substantially contributed to the conception and the design of the work. YZ and MS participated in the acquisition of data. LL analyzed, interpreted the data, and prepared the draft. YW revised the manuscript. All authors worked for the final approval of the version to be published and were accountable for all the aspects of the work in ensuring that questions related to the accuracy and integrity of any part of the work are appropriately investigated and resolved.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Total hip arthroplasty (THA) has been used for over five decades for treating hip osteoarthritis. THA is a surgical procedure associated with prolonged hospital length of stay (LOS). The aim of this study was to analyze whether a protocol developed for fast-track THA could decrease the time taken to reach functional recovery after surgery and the hospital LOS. Blood transfusion and critical care requirements and the complication rate were evaluated as secondary endpoints.t test, and Poisson regression approach.Ninety-eight patients underwent THA at the University Hospital of the Federal University of Maranhão . The control group included 51 patients who underwent THA through the conventional method. The fast-track surgery (FTS) group included 47 patients who underwent THA through the FTS approach. The inclusion criteria were that the subjects needed to present hip osteoarthritis and at least one clinical indication for THA, and that their risk classification was in ASA category I or II. The following factors were evaluated: age, sex, diagnosis, laterality, type of arthroplasty, blood transfusion, critical care requirement, complications, LOS, and need for re-hospitalization for any reason. For spinal anesthesia, an opioid-free protocol was used. Comparison of categorical variables between the groups was performed using the chi-square test, Shapiro-Wilk test, Student p > 0.05). The majority of the patients in the control group required both blood transfusion and use of the critical care unit, thus differing from the patients who underwent FTS (p < 0.001). The mean hospital LOS in the FTS group was 2.3 ± 0.8 days, compared with 6.4 ± 1.5 days in the control group (p < 0.001).The FTS and control groups were similar in age and sex distribution (Use of FTS was associated with decreased LOS, compared with conventional THA.https://www.researchsquare.com/article/rs-369025/v1. Total hip arthroplasty (THA) has been used for over five decades for treating hip osteoarthritis, with the aims of reducing pain levels and ameliorating articular function and quality of life . FurtherNovel evidence-based protocols targeting surgical patients’ care emerged in the early 1990s, with the aim of accelerating postoperative recovery. These were put forward by Professor Henrik Kehlet for use within colorectal surgery. This approach is named fast-track surgery (FTS) or enhanced recovery after surgery (ERAS) . FTS is On the other hand, use of FTS has also been linked to increased rates of complications and readmissions . NonetheThe increasing worldwide demand for arthroplasties is mainly due to the marked augmentation of the population’s longevity over recent decades, with subsequent elevation of public healthcare costs , 18, 19.This study was approved by our institution’s ethics committee under the number 1.829.945. The inclusion criteria were, for both conventional and FTS group, that the subjects needed to present hip osteoarthritis and at least one clinical indication for THA, and that their risk classification was in American Society of Anesthesiologists (ASA) score I or II. Patients who met the inclusion criteria and agreed to participate in the study received both oral and written information about the study purposes, signed an informed consent statement, and were then included in the study. Patients with decompensated comorbidities (ASA III or IV) or neurological disease, and those who underwent THA due to hip fracture, infection, or revision of previous THA were not included in the study. We also excluded patients for whom it was not possible to perform THA using spinal anesthesia.A total of 98 patients underwent THA at the University Hospital of the Federal University of Maranhão . These patients were allocated into two groups. The control group included patients who underwent THA through the conventional method, and who were operated between January 2012 and November 2016. The FTS group included patients who underwent THA through the FTS approach, in the period from December 2016 to January 2018.A single surgeon performed the operations on all participants. Surgery was performed on a standard operating table without special attachments, through a posterolateral approach under spinal anesthesia. Prophylaxis against infection was implemented using cefazolin (2 g), starting 30 min before induction of anesthesia and continuing for 48 h. Prophylaxis against venous thromboembolism was identical in both groups, and consisted of use of low molecular weight heparin  during hospitalization and maintained through use of oral anticoagulant  for four weeks after hospital discharge. The outpatient follow-up included a 15-day return for suture removal and x-ray control, and subsequent return visits after 1, 3, 6, and 12 months.The following factors were evaluated: age, sex, ASA score, hypertension, diabetes, obesity, diagnosis, laterality, type of arthroplasty, complications, blood supply, ICU postoperative support, LOS, and need for re-hospitalization for any reason. The complications investigated included deep or superficial infection, thromboembolic events, mortality, pneumonia, urinary tract infections, intraoperative fracture, renal failure, or any other medical conditions that could result in prolonged hospital stay.A total of 51 patients underwent conventional THA. In the protocol used, the patients and their families did not receive any detailed written information about the surgery; a multidisciplinary approach was not encouraged; opioids were routinely used for induction of anesthesia, spinal anesthesia, and postoperative pain management; a bladder catheter was routinely utilized; use of ICU support was mandatory; and functional rehabilitation started from the first or second postoperative day. There was no clearly defined hospital discharge goal.A total of 47 patients underwent THA through the FTS approach. Detailed information was provided to the participants and their family members regarding the surgical procedure, potential complications, rehabilitation, and the intent to reach hospital discharge within three days after surgery . A multiFor spinal anesthesia, an opioid-free protocol using bupivacaine (0.5%) and clonidine (15 μg) was used. Delayed bladder catheterization was not performed. Prophylaxis against blood loss consisted of administering TA (15–20 mg/kg) before induction of anesthesia. A combination of ropivacaine (2 mg/mL), ketoprofen (100 mg), and methylprednisolone (40 mg) was infiltrated as a peri-articular injection (PAI).After the surgical procedure, the patients then underwent a rehabilitation stage comprising mobilization in bed, within the first 6 h after surgery. They were encouraged to sit up for about 30 min, and then underwent orthostatic and gait training according to their pain tolerance. These rehabilitation procedures were dependent on absence of nausea, vomiting, malaise, dizziness, or hypotension.The criteria for hospital discharge took into account the patients’ clinical stability, spontaneous mobilization in bed, acceptance of oral diet, pain control with oral medication, and desire to go home.The differences between the conventional and FTS protocols are summarized in Table t test. For multivariate analysis, a generalized linear model was developed, in which the number of days from surgery until hospital discharge was taken to be the dependent variable. Other variables were used as independent variables in the model, and all of them were forced into the equation. A Poisson regression approach was then used to obtain incidence rate ratios (IRRs) and confidence intervals (CIs). The data were analyzed in the SPSS Statistics for Windows software, version 24.0 . The significance level was taken to be 5% for all analyses.Comparison of categorical variables between the groups was performed using the chi-square test. The normality of numerical variables was tested using the Shapiro-Wilk test, and means ± standard deviations were compared using the Student A total of 98 individuals were included in the current study, among whom 51 underwent conventional THA and 47 underwent fast-track THA. A comparison of sociodemographic and clinical data is presented in Table p > 0.05), and most patients were older than 50 years. Sex distribution, ASA score, hypertension, diabetes type 2, and obesity did not differ between the two groups (Table p < 0.05). The cementation and implant characteristics were similar between the two groups (p > 0.05). The majority of the patients in the control group required both blood transfusion and use of the ICU, thus differing from the patients who underwent FTS (p < 0.001). No patient in the FTS group stayed in hospital for more than 6 days, whereas for 56.8% of the controls, the time that elapsed until hospital discharge was seven or more days (p < 0.001) (Table p < 0.001).The FTS and control groups were similar in age distribution (1) Table . The meaNeither in the FTS group nor in the control group were there any cases of thromboembolic events, infections, readmissions, or deaths. Five cases of surgical complications were observed in the FTS group, including one of traumatic dislocation, one of sciatic nerve partial neuropraxia and three of periprosthetic fracture. Among the conventional group, we also noticed two cases of partial sciatic nerve neuropraxia. The occurrence of such complications in both groups took place after surgery process and was not related to preexisting comorbidities..In the present study, we evaluated whether FTS could reduce the hospital LOS, in comparison with conventional THA. It has been estimated that the number of THA operations performed will double within the next decade , 18, andRecent advances in preoperative education, blood conservation, standardized anesthetic protocols, postoperative care with pain management, and early mobilization have led to popularization of FTS for THA –7. A FTSAdditionally, the implementation of this FTS protocol has included both preoperative education for patients and their family members and the development of a multidisciplinary team that had previously not yet become integrated. The main outcome that was expected from the implementation of this protocol was a reduction in the hospital LOS, along with a decreased need for ICU support. After the introduction of the FTS protocol, the number of THA procedures performed was significantly augmented without an increase in the occurrence of complications.One prerequisite for promoting effective rehabilitation and optimizing mobilization in bed is to achieve adequate pain control with few adverse effects. This was achieved in the present study through using an opioid-free protocol consisting of a combination of bupivacaine and clonidine, for spinal anesthesia. Clonidine is a 2-adrenergic agonist that has analgesic properties and boosts the effects of local anesthetics when administered via the epidural route, with few postoperative adverse effects , 23. ThiIn our study, a total of four cases of urinary retention occurred in the FTS group and required use of postoperative relief. In the control group, which underwent spinal anesthesia using morphine, all the patients received a delayed bladder catheter immediately after anesthesia. Other benefits of the opioid-free protocol were absence of or decreased adverse effects such as pruritus, constipation, malaise, nausea, and postoperative vomiting.Relief of acute pain after THA is a major therapeutic challenge, given that postoperative pain hinders early mobilization and rehabilitation, which subsequently leads to longer periods of resting in bed and prolonged hospital LOS , 11. AdmPostoperative anemia is a very common clinical condition observed in THA, which requires blood transfusion in 33 to 74% of the cases . The cosIn the present study, in order to reduce the risks relating to blood transfusion in the postoperative period following FTS, the patients in this group were screened for transfusion risk factors and then treated when serum hemoglobin was < 12 g/dL . Closed Another very useful strategy that was adopted in order to obtain good hemostasis during surgery was intravenous administration of TA in a single dose of 15–20 mg/kg, before induction of anesthesia . TA is aThis measure drastically reduced the need for blood transfusion in the FTS group. Blood transfusion was only required in two patients. One of these patients had sickle cell anemia and the other had rheumatoid arthritis. Both of them showed acute signs of anemia, confirmed by laboratory tests, which therefore required two units of erythrocyte concentrate each. They underwent rehabilitation on the second postoperative day and remained hospitalized for four nights after surgery. It is important to note, in comparison, that as many as 74.5% of the patients in the control group required blood transfusion. Blood transfusion is considered to be an important predictor in relation to hospital discharge , 27. PriOnly one patient in the FTS group required the use of the ICU in the postoperative period. However, this was a preoperative indication based on the individual’s advanced age. The majority (72.5%) of the patients in the control group required critical care support. Neither in the FTS group nor in the control group occurred any cases of thromboembolic events, infections, heart attack, readmissions, or deaths.Regarding the surgical complications observed in the FTS group, one case of sciatic nerve paresthesia and one case of traumatic dislocation of THA were observed. These patients underwent appropriate treatment and stayed in hospital for 5 days. Two cases of periprosthetic fracture of type Vancouver B1 and one case of type Vancouver Al were radiographically identified in the immediate postoperative period. These patients then underwent conservative treatment with a 6-week load restriction. Another case of fracture was identified at the level of the minor trochanter. The time until hospital discharge in these cases ranged from three to five days, and all of these patients evolved well, with fracture healing and no requirement for reoperation. In the conventional group, two cases of partial sciatic nerve paresthesia occurred. We emphasize that such events in both groups were caused by surgical procedures, therefore, there is no direct connection between FTS program implementation and these complications.Another factor that needs to be observed is whether there is any family support . In the The time needed to reach hospital discharge in THA cases is a subject of great debate, and there is no consensus on the ideal criteria that should be met for safe hospital discharge. Normal vital signs, adequate pain control, and safe mobilization are usually considered to be requirements . HoweverThe hospital LOS in our study was notably lower in the FTS group  than in the control group , stability of vital signs, a desire to go home, and the existence of family support are relevant for achieving safe hospital discharge , 35, 36.It needs to be mentioned that this study had several limitations, including the small sample size, the evaluation at a single center, and the fact that interventions were not performed in a parallel fashion in the two groups. Prospective multicenter cohort studies in this regard are thus warranted.The use of FTS was associated with reduced hospital LOS, compared with conventional THA. FTS consisted of multimodal and multidisciplinary standardized care in which the aims were to achieve pain control, early mobility, and early discharge.


Background and Aims: Cardiovascular diseases (CVDs) are the leading cause of death globally and in Brazil. Evidence suggests that the risk of CVDs differs by race/ethnicity. Scarce information exists about the association between CVD risk, obesity indicators and sociodemographic characteristics in the Brazilian population.Objectives: We aimed to assess the CVD risk following the Framingham risk score in relation to the population's sociodemographic profile. Further, we examined the association between anthropometric markers and risk of CVDs.Methods: A total of 701 subjects aged ≥20 years from North-eastern Brazil were recruited randomly to participate in a population-based, cross-sectional survey. Age-adjusted data for CVD risk, sociodemographic characteristics, and anthropometric indices were assessed, and their relationships examined.Results: High CVD risk (Framingham risk score ≥10%) was observed in 18.9% of the population. Males (31.9 vs. 12.5%) and older subjects (age ≥45 years: 68.9% vs. age <45 years: 4.2%) had significantly higher risk of CVDs, whereas those employed in manual labor showed lower risk (7.6 vs. 21.7%). Central obesity measures like waist-to-hip ratio and waist-to-height ratio were more strongly associated with predicted CVD risk than body mass index.Conclusions: Our population had a high risk of CVDs using the Framingham risk score. Cost-effective strategies for screening, prevention and treatment of CVDs may likely reduce disease burden and health expenditure in Brazil. Central obesity measures were strongly associated with predicted CVD risk and might be useful in the clinical assessment of patients. Follow-up studies are warranted to validate our findings. Cardiovascular diseases (CVDs) have reached epidemic proportions worldwide, with a greater impact in low- and middle-income countries (LMICs), including Brazil . In 2016Most CVDs are caused by a complex interaction of several modifiable risk factors, including tobacco use, physical inactivity, unhealthy diet, overweight and obesity, harmful use of alcohol, hypertension, diabetes, and dyslipidaemia . RecentlOverweight and obesity have been regarded as one of the leading factors for mortality, accounting for around 23% of the ischaemic heart disease burden , 6. SeveEvidence suggests that the risk of CVDs differs by race/ethnicity . In BrazThis cross-sectional study was carried out between August 2012 and January 2013 in the city of Pindoretama, located in the state of Ceara (CE), North-eastern Brazil. The recruitment and examination procedures have been discussed previously . AccordiSubjects of both genders, aged ≥ 20 years who were able to communicate and willing to participate in the study were considered eligible. Those with an acute or chronic severe cardiac, renal, or hepatic illness, as well as physically or mentally disabled subjects unable to follow simple questions and examinations were excluded, as were pregnant women. Since we aimed to assess the CVD risk, those with a previous history of myocardial infarction and/or stroke were considered as having had the condition, and therefore were excluded from the analyses (13 subjects). Seven hundred and one subjects remained. At the time of recruitment, the subjects were requested to visit a nearby health center after an overnight fast of 8–10 h. Pre-tested questionnaires were conducted by trained interviewers to collect sociodemographic and clinical information. Anthropometric measurements, blood pressure, and body fat percentage (BF%) were also registered.n = 4 (zcrit)2p (1–p)/D2 , “p” = 0.051 prevalence estimate from a previous study of high/intermediate risk of CVD according to the Framingham risk score . Two-tailed statistical analyses were used. Thus, n = 4 × (1.96)2 × 0.051 × 0.949/(0.0454)2; n = 360.83.The required sample size was calculated by the formula: (1–p)/D2 . The totsk score , and “D”The study was conducted according to the ethical principles outlined in the Helsinki Declaration . The res2). BF% was determined by a portable bipolar body fat analyser . WC was measured with a non-stretchable tape, positioned horizontally in the middle area between the lower border of the ribs and iliac crest, under the mid-axillary line. HC was assessed with the same tape positioned to the maximum circumference around the buttocks, with the subjects standing straight. WC and HC were recorded to the nearest 0.1 cm. WHR was calculated as the WC divided by the HC, while the WHtR as the WC divided by the height.Weight, height, WC, and hip circumference (HC) were taken with subjects standing without shoes and wearing light clothing. Body weight (kilograms) was registered to the nearest 0.1 kg using a portable digital scale, calibrated before use and checked every day with a known weight. Height (centimeters) was measured by applying a well-mounted stadiometer, with each subject standing upright with their head in the Frankfurt plane. BMI was calculated as the weight in kilograms divided by the square of the height in meters (kg/mBlood pressure (mmHg) was estimated twice at a 10-min interval using a validated automatic sphygmomanometer , with appropriate cuffs, in a sitting position after a resting time of at least 15 min. The mean of the two readings was used for the analysis.On arrival at the data collection center, a 10-mL fasting venous blood sample was taken to determine the concentrations of plasma glucose, insulin, and lipids. Two hours after a 75g oral glucose load, another 3 ml of venous blood was drawn for the oral glucose tolerance test (OGTT). Blood samples were stored immediately over ice and centrifuged after 1 h. Plasma was frozen and transported to the laboratory, where the samples were stored at −20 °C until the analyses were conducted. Quality control of the laboratory was assessed internally and externally.The glucose oxidase method was applied to estimate fasting and 2-h plasma glucose levels, whereas fasting insulin was determined by chemiluminescence. Total cholesterol (TC) was assessed by the cholesterol oxidase - phenol + aminophenazone (CHOD-PAP) method, while a homogenous enzymatic colorimetric method was used to determine high-density lipoprotein cholesterol (HDL-C) levels. Triglycerides (TG) were assessed by the glycerol-3-phosphate oxidase - phenol + aminophenazone (GPO-PAP) method. The Friedewald Formula  was appl2. A high WC was described as > 102 cm for males, and > 88 cm for females  were applied, i.e., for males, a WHR ≥ 0.90 was classified as “high” , whereas, for females, a WHR ≥ 0.85 was considered “high”. Overweight/obese was defined by a BMI of ≥ 25 kg/m females . A cut-o females .Following the definition of the Brazilian Institute of Geography and Statistics (IBGE) classification, ethnicity was assessed according to the subjects' self-perception of their skin color. The different ethnic groups were categorized into “white” and “non-white” . PhysicaThe 1999 WHO criteria  were appThe Framingham 10-year risk score model, as published by D'Agostino et al.  in 2008,th edition , while percentages and 95% CIs were given for categorical variables. Generalized linear regression models (GLM) were fitted to the data after adjusting for age. To compare differences between adjusted means, we fitted GLMs with linear link function, while GLMs with the logit link function were applied to compare differences between proportions. The prevalence of those with a predicted 10-year CVD risk of ≥ 10% was calculated as predictive margins, based on the estimation of the adjusted logistic regression models. To control confounding by age in the predicted means and prevalence, we fixed age at 45 years, which was the closest to the mean age in the sample. A two-sample test of proportions was applied to compare the prevalence of high CVD among the different sociodemographic groups. Anthropometric measurements were converted to z-scores [original value subtracted by the mean and divided by the standard deviation (SD)] to represent the number of SDs above and below the mean for each subject. Multiple linear regression was carried out to investigate the relationship between the standardized anthropometric markers and CVD risk. Further, we calculated crude and adjusted prevalence ratios (PRs) of the anthropometric indicators for detecting high CVD risk using Poisson regression with robust variance, as the prevalence of high CVD risk was above 10%. We tested for two-way interaction between age and the different anthropometric markers. The Akaike Information Criteria (AIC) was used to compare nested models. Data were analyzed using Stata 15 edition  and SPSS version  statistiA total of 701 subjects  were included in the analysis. Significant differences were found in sociodemographic, lifestyle, anthropometric and cardiometabolic characteristics between the genders . Males hThe mean predicted Framingham risk score increased substantially with age and was higher among males . In addip-value: < 0.001), and those with more than 45 years of age . Furthermore, it was significantly lower among those with an occupation requiring manual labor , defined as jobs in agriculture and construction.As shown in Multiple linear regression was carried out to assess the age-adjusted associations between 1 SD increment in each anthropometric marker and the predict risk of CVDs, entered as a continuous variable . In malep-value < 0.001) and females . This large PR and wide CI in the adjusted model for females and WHtR was due to the few observations of those with high CVD risk and WHtR <0.50 (6 subjects).To the best of our knowledge, this is one of the few population-based studies from Brazil to investigate the CVD risk by sociodemographic characteristics, as well as the association between different obesity markers and the risk of a cardiovascular event. Males and older people presented higher risk of CVDs in our population, whereas those employed in the manual labor had significantly lower risk. Central obesity measures were more strongly associated with CVD risk than BMI.We found a high prevalence of increased CVD risk, i.e., Framingham risk score ≥ 10%, in this population. Our estimates were higher than those reported in Peru , ArgentiConsistent with previous research , 41, 42,We found that the adjusted PR for WHR and WHtR were the highest among the anthropometric indices in relation to increased CVD risk. Further, the association between the WHR and Framingham risk score entered as a continuous variable was higher than that of WC, BMI and WHtR in females, whereas the slope coefficient of WHtR was the highest in males followed by WC. These results may indicate that these central obesity measures were more predictive of CVD risk than the general obesity measure like BMI. Therefore, in line with several others , 10, ourSome studies have identified WC as the most highly correlated marker with CVD risk factors compared with other central obesity measures and BMI in females . NeverthThis study contributes to the limited body of evidence from Brazil on CVD risk and sociodemographic characteristics, as well as on the association between different obesity measures and the risk of CVDs. The subjects were randomly selected, and the participation rate was high. The survey was performed by trained personnel and pre-tested questionnaires were applied. To minimize the risk of misclassification errors due to poor recall, anthropometric parameters were carefully assessed, and no self-reported measures were used. Blood samples were collected, handled, and transported according to standard protocols. Quality control of the laboratory was assessed internally and externally.Our study had some limitations. It was based on a cross-sectional design and the 10-year CVD risk was calculated instead of using prospective CVD events. Nevertheless, the study generated valuable epidemiological data from Brazil regarding the association between CVD risk, obesity indicators and sociodemographic characteristics. Considering that Brazil is a large country with marked socioeconomic, ethnic, and regional disparities, our findings may not be representative for the whole nation. Caution should be taken when generalizing the results. However, since Brazilians have a mixed background, our sample might be a fair representation of the country's population. Furthermore, we had an overrepresentation of females . As previously mentioned, out of 1,000 names randomly selected from the healthy registry list, around 163 subjects were not found by the CHW and therefore could not be invited to participate in the study. Out of these 163, approximately 78% were males. Additionally, among 92 subjects who refused to participate, around 63% were males. Population-based studies conducted during the day may constitute a hindrance to male participation. Males are often involved in income-generating work and therefore may not have been able to participate in the survey. The overrepresentation of females was dealt with by adjusting the analyses for gender or stratifying by gender. The Framingham risk score was not recalibrated for our population, which might have introduced some uncertainty in the CVD risk estimation. However, this was beyond the scope of the study and our available resources. Furthermore, the Framingham risk score has been widely applied and validated in ethnically diverse cohorts including whites, blacks, Native Americans, and Hispanics .A high risk of CVDs according to the Framingham risk score was found in this population, especially among males and older people. In addition, manual labor seems to provide a protective effect on CVD risk. A timely targeted investment in screening, prevention, and necessary treatment of CVDs could reduce the burden on many and reduce the pressure on the health budget. Central obesity measures are more strongly associated with CVD risk than general obesity indicators. Our data suggest that WHR and WHtR are the best anthropometric markers to identify high CVD risk. Since an increase in muscle mass might not lead to changes in BMI , centralThe raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by the Local Ethical Committee in Brazil (Protocol Number: 045.06.12) and the Regional Committee for Medical and Health Research Ethics (REK) in Norway (Reference: 2012/779/REK sør-øst D). The patients/participants provided their written informed consent to participate in this study. In case of illiteracy, verbal consent was assured by a local witness, who signed the informed consent, to secure the free participation of the subjects.NM contributed to the conceptualisation of research goals and design, drafting of the article, as well as acquisition, analysis, and interpretation of the data. AH contributed to the study concept and design, data analyses, writing the initial draft and revising it critically, study oversight, and leadership. BB participated in the analysis and interpretation of data, writing the article, and revising it critically. IM took part in conceptualizing the study aims and design, writing the initial draft and revising it critically, as well as organizing the database, and conducting the statistical analysis. TS contributed to the design of the study, data curation and analyses, and drafting of the article. VF contributed to conceptualizing the work and designing the methodology, data collection and analyses, writing the initial draft, and revising it critically. RM contributed to the study concept and design, data analyses, study management and coordination, as well as writing the initial draft, and revising it critically. HM contributed to the design of the methodology, data analyses, study oversight and leadership, writing the initial draft, and performing critical review. All authors read and approved the content of the final manuscript. Furthermore, they agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.This study was funded by the Ivar Helles Foundation, and the Health Department of the city of Pindoretama-CE.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Sucrose was the main soluble sugar found in analyzed formulations, and raffinose was the prevalent oligosaccharide, followed by stachyose. The content of total α-galactosides tended to be higher after extrusion cooking. As a consequence of the extrusion treatment, the content of total and soluble dietary fiber was statistically increased in most of the analyzed samples. In general, no significant changes were observed in total arabinoxylan content as a consequence of the extrusion process, while the content of water-soluble arabinoxylans was significantly increased in extruded formulations. It was observed that the content of total available carbohydrates, stachyose, and water-soluble arabinoxylans were significantly influenced by the addition of passion fruit, Fibersol®, and both. The incorporation of these ingredients in gluten-free formulations based on chickpeas and rice allows one to obtain suitable functional formulations for the development of innovative, gluten-free, extruded snack-type products, which could be an interesting alternative for people with celiac disease.Extrusion cooking allows the development of value-added products from pulses, such as gluten-free snacks with added functional properties. The main objective of this study was to evaluate the changes induced by the extrusion process on the carbohydrate fraction  of novel flour formulations based on chickpeas and rice enriched with different dietary fiber sources. Moreover, the influence of the addition of fiber-rich ingredients, such as Fibersol Extrusion is a versatile, high-temperature–short-time technology that allows the production of fully cooked, low-moisture, and shelf-stable food products ,2. Nowad®, which is a water-soluble, nonviscous, and highly digestion-resistant maltodextrin that stimulates the production of satiety hormones and enhances satiety in humans . Inv/v aqueous ethanol, and the residue obtained, after evaporation and dryness, was redissolved in 1 mL of double-deionized water and centrifuged for 10 min at 10,000 rpm. After that, the obtained samples were filtered through a 0.45 µm Millipore membrane, and 20 µL of each extract was injected into an HPLC system  equipped with a Spherisorb-5-NH2 column , equilibrated with acetonitrile/water 60:40 (v/v), and a refractive index detector. The flow rate was 1 mL/min and the samples were analyzed in duplicate. Calibration curves for all standard sugar solutions were prepared. Individual sugars were quantified by comparison with external standards of pure sucrose, maltose, raffinose, stachyose. and verbascose ; ciceritol and galactinol were purified and kindly supplied by Dr. A. I. Piotrowicz-Cieslak .The concentration of soluble sugars and oligosaccharides in the raw and extruded flours was determined by high-performance liquid chromatography (HPLC), using a procedure described by Muzquiz et al. (1992)  and modiTotal, soluble, and insoluble dietary fiber were determined according to AOAC enzymatic–gravimetric methods 993.19 and 991.42 . An amoud-(+)-xylose in 100 mL of distilled water. Then, triplicate standard samples were prepared using different concentrations of xylose (0.005–1 mg mL−1). The absorbance was measured at 448 and 508 nm for determination of the arabinoxylans. In order to remove the influence of hexoses (mainly glucose), the absorbance reading at 508 nm was subtracted from the sample readings at 448 nm. The referred wavelengths were selected after performing a full scanning to check the maximum absorbance of the sugars. The values were expressed as g per 100 g flour. Total arabinoxylans (TOAX) and water-soluble arabinoxylans (WEAX) were quantified using a colorimetric method. An amount of 100 mg of each sample was placed in a conical polypropylene tube, and 25 mL of distilled water was added. After shaking for 30 min, 0.5 mL of the sample suspension was quickly removed and pipetted into a stoppered reaction tube in order to determinate the TOAX content. The original sample suspension was centrifuged for 10 min at 2500 rpm . After centrifugation, 0.5 mL of the supernatant was removed and pipetted into an amber reaction tube for determination of WEAX content. Once the sample aliquots were collected, 1.5 mL of distilled water was added to bring the final volume to 2 mL. The calibration curve was prepared using a stock solution of 10 mg of ®). Duncan’s Multiple Comparison Test was applied to identify the differences among the sets of means. All statistical analyses were performed using Statgraphics Plus 5.1 software . The statistical significance level was set at p < 0.05.Mean ± standard deviations (SD) of the sample data were determined and statistically analyzed by Analysis of variance (ANOVA). In addition, two-way interactions were included in the ANOVA in order to examine the impact of the ingredients added to the formulations for enrichment (passion fruit and Fibersol® and passion fruit. Therefore, the incorporation of these ingredients in extruded gluten-free formulations based on rice and chickpeas could be an interesting alternative so as to increase the range of snack-type products marketed for people with celiac disease. The study of the morphology of the extrudates, as well as the use of other processing temperatures, would be additional interesting aspects of a future study to relate morphology and effect of temperature on resulted extrudates.In recent years, demand for healthier products in the snack market has increased substantially, with most of those made from pulse flours. In this sense, the food industry is required to innovate by using new processing technologies, as well as novel ingredients, to develop innovative products that meet the consumers’ demand. The results of this study showed that the extrusion process is an interesting technology which allows one to obtain suitable gluten-free formulations with added functional properties, as extruded flours based on rice and chickpeas were higher in dietary fiber, water soluble arabinoxylans, and oligosaccharides. Moreover, the chemical composition of analyzed gluten-free formulations has been influenced by the addition of fiber-rich ingredients, such as Fibersol


Significant positive correlations were found between maternal serum Se concentrations and zinc (Zn) and copper (Cu) in the total and regional cohorts. In the total cohort, the toxic elements lead (Pb) and arsenic (As) showed a negative correlation with Se levels, while mercury (Hg), aluminum (Al) and cadmium (Cd) showed a positive correlation. The study found a sex-dependent response in utero for Zn, Cu, Pb, Hg, and Al. The findings of the current study may inform reproductive health policy on Se status in South Africa and highlight the need for sensitive methods to measure Se intake during pregnancy and its complex interactions with other micronutrients and environmental pollutants.Selenium (Se) is an essential trace element and its deficiency in utero may affect fetus development and birth outcomes. The current study aimed to assess serum Se status at delivery and examine the possible association between Se levels and birth outcomes. The interaction of Se with selected essential and toxic elements as well as possible sex-dependent responses in utero were also evaluated. The negative association between Se levels and head circumference of neonates was evident in the total cohort (β = −0.164;  Selenium (Se) is an essential trace element and its status in humans and other mammals depends primarily on dietary intake, with the main sources being meat, cereals, and seafood . GloballThe levels of Se are highly regulated in biological systems and incorporated into selenoproteins. Se plays an integral role in immune function and antioxidant defense, with 25 genes expressing selenoproteins in the human genome ,7,8,9. SNumber of studies have shown that Se can easily be transferred from the mother to the fetus ,18,19). ,19. 18,1In humans, Se deficiency may affect the heart, weaken the immune system, and cause hypothyroidism ,23,24. FIt is of concern that low Se status during pregnancy may result in adverse pregnancy outcomes such as miscarriages and premature birth, neural tube defects, low birth weight, and gestational diabetes ,31,32. FIt is understood that since Se is an essential trace metalloid, it plays a detoxification role in metal toxicity by mitigation of cadmium (Cd) and arsenic (As) induced tissue injuries ,37,38. IDue to the essential functions that Se plays in human health, many studies have been undertaken to evaluate Se status in the general population, in women of reproductive age, and in pregnant women. To date, there is a paucity of such investigations in the Southern Hemisphere and as far as the literature reviews inform, no investigations have been conducted into Se levels in pregnant women nor the general population in South Africa.The current study assessed Se status in utero at delivery and examined the possible association between Se levels and birth outcomes in coastal populations in South Africa. Furthermore, the association of Se with selected essential and toxic elements was investigated as well as possible sex-dependent responses to Se exposure in the neonates.This study is a part of the multi-disciplinary and multi-national research collaboration between South Africa and Norway that evaluates prenatal exposures to environmental pollutants and their effects on reproductive outcomes; the study was carried out under the auspices of the Arctic Monitoring and Assessment Program (AMAP).In total, five study sites were chosen along coastal regions of South Africa  province, and two sites at the Atlantic Ocean coast of the Western Cape province) . All sitA sterile Venoject system and Becton, Dickinson & Company  collection tubes were used for all blood collections. Each study participant donated 10 mL of venous blood into a non-additive tube to obtain serum fractions for the analyses of Se, copper (Cu), zinc (Zn), and aluminum (Al). The serum tubes were centrifuged and the serum was transferred to acid-washed polypropylene tubes using acid-washed plastic pipettes. For the analyses of toxic elements such as Hg, lead (Pb), manganese (Mn), Cd, and As in maternal whole blood, 10 mL of venous blood was collected into tubes containing ethylene diamine tetra acetic acid (EDTA). Samples of serum (post-centrifugation) and whole blood samples were stored at −20 °C and couriered in a frozen state to the National Institute for Occupational Health (NIOH) laboratory, Johannesburg, South Africa. All precautions to eliminate and prevent contamination at collection and during the preparation of samples were applied throughout. All samples were analyzed using an Agilent Inductively Coupled Plasma Mass Spectrometer (ICP-MS) 7900 with an Octopole Reaction System. The serum samples were analyzed at Lancet Laboratories, Johannesburg, and whole blood samples were analyzed at the NIOH laboratory, Johannesburg, South Africa. Both laboratories participate in a proficiency testing scheme for biological samples.For the measurement of Al, Cu, Zn, and Se in serum, samples were diluted 20-fold with a diluent . Ammonia, butanol, and EDTA were purchased from Merck Chemicals (PTY) Ltd., South Africa: Triton-X, calibration standards and internal standards were purchased from Industrial Analytical, South Africa. The following internal standards were also added to the diluent, indium , germanium , scandium , rhodium , and iridium . The ICP-MS instrument was calibrated with calibration standards prepared in a diluent using a multi-element custom standard (SPECTRASCAN–SS028226). The concentrations of the standards for Se, Cu, and Zn ranged from 0.1 to 100 µg/L, and for Al, the range was 0.1 to 50 µg/L. The internal standards used were Sc, Ge, Ge, and Ir for Al, Cu, Zn, and Se, respectively. The instrument was run in general purpose mode using helium gas.Two certified reference controls, Seronorm™ Trace Elements Serum  were analyzed with every analytical run in intervals of 10 samples for quality assurance of all element measurements. The percentage recovery for Cu, Zn, and Se was 88–104%, and 91–114% for Al. The coefficient of variation was 8.76%, 4.56%, 4.87%, and 6.88% for Al, Cu, Zn, and Se, respectively. The limits of quantitation (LoQ) for Al, Cu, Zn, and Se were 0.15, 0.06, 0.31, and 0.17 µg/L, respectively.The collection and analyses of samples for the selected elements manganese (Mn), Hg, Pb, Cd, and As in maternal whole blood have been described previously ,42,43,44In short, analyses for the whole blood samples were performed on an ICP-MS, following digestion in nitric acid. Two blood certified reference controls, Seronorm ™ Trace Elements , were used. The percentage recovery of the Seronorm controls for the metals measured in blood ranged from 83–108%. The detection limits for Mn, Hg, Pb, Cd, and As were 0.07, 0.08, 0.04, 0.03, and 0.13 µg/L, respectively.Information on covariates was obtained from interviewer-administered questionnaires and hospital medical birth records of the neonates. Demographic and socio-economic status questions such as age, race/ethnicity, marital status, educational status, employment status, housing type, and source of water supply as well as self-evaluated health status were included in the questionnaire. Questions on nutrition of the mothers before and during pregnancy were also asked; these included the consumption of meat and fish, dairy products, and fruits. Additionally, the types of fuel used for the purpose of either cooking or heating were included in the questionnaire, as were smoking habits. Birth weight (g), birth length (cm), head circumference (cm), gestational age (weeks), Apgar score at 1 and 5 min, and placenta weight (g) were obtained from the medical records of the neonates.p < 0.05 for all models.Data analyses were carried out using STATA version 12 . The ChiThe study protocol was approved by the Human Research Ethics Committee of the University of Witwatersrand in Johannesburg (Protocol no. M10742), and by the Departments of Health of the different provinces. Personal data confidentiality and sample collection were carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki). Confidentiality was maintained by assigning identification numbers to all study participants.Although the total number of study participants was 650 , the socio-economic, demographic, obstetrics, and birth outcome data reflected in When examining the socio-economic and demographic characteristics of participants  by geogrThe dietary intake of basic food items before and during pregnancy was significantly different between the two regions for fruits, meat, and dairy products. However, there was no difference between regions for the consumption of fresh fish.The descriptive data for total and regional obstetrics and birth outcomes are shown in p < 0.001). There were no differences in the median values of maternal weight, maternal height, and birth weight, and in the categories of the Apgar scores at 5 min between the two regions. For the Apgar score at 1 min, the number of neonates with scores between 7 and 10 was higher in the Indian Ocean region than in the Atlantic Ocean region .The average gestational age was 38.2 weeks with 49.9% of neonates being males. In the total cohort, the median age of mothers was 24.0 years with about 44% being primiparous (results not shown). There were differences in median gestational age between the Atlantic Ocean and the Indian Ocean regions  data of the associations between maternal serum Se and birth outcomes for total, pre-term, and full-term deliveries are presented in p < 0.001) and in both the pre-term  and full-term neonates . However, there was no correlation between maternal serum Se and birth length, birth weight, or Apgar scores at 1 min and 5 min of all the neonates.Spearman’s rank correlation coefficient (p < 0.001) as well as in the pre-term  and full-term  cohorts. Additionally, there is a positive correlation between parity and maternal Se in the total cohort  and the full-term cohort .The main finding related to birth outcomes is that the head circumference of neonates is significantly negatively correlated with maternal serum Se levels in the total cohort  for Se in serum for the total cohort was 65.9 µg/L, whereas the GM for Cu and Zn was 483.8 and 2423.3 µg/L, respectively. The GM concentrations of Mn and Pb in blood were found to be 15.1 µg/L and 13.2 µg/L, respectively. The GM for Al in serum was found to be 9.1 µg/L, and the GMs for Hg, As and Cd concentrations were 0.8 µg/L, 0.6 µg/L, and 0.3 µg/L, respectively.p-value) of the association between Se and measured essential and toxic elements at delivery in total and regional cohorts.As expected, significant positive correlations were found between maternal Se concentrations and Zn and Cu, which are essential elements, in all cohorts. In contrast, for Mn  there were negative correlations with Se in the total cohort and in the Indian Ocean region, but these were not statistically significant. The measured toxic elements in maternal blood showed negative and significant correlations between Se and Pb and As in the total cohort only. Significant positive correlations were evident between Se and both Hg and Al in the total and Atlantic Ocean cohorts. There were also positive correlations between Se and Cd in the total and Indian Ocean cohorts.Significant positive correlations were found between maternal Se concentrations and maternal Zn levels in the total and male cohorts, with a marginal significance level also observed in the female cohort. In all cohorts, maternal Cu serum was positively correlated with the maternal Se concentration. For the toxic elements, maternal blood Pb levels were negatively and significantly correlated with maternal Se concentrations in the total and male cohorts. Maternal Hg concentrations were positively associated with maternal Se in all three cohorts. Maternal Se was negatively associated with As in all three cohorts, but found to be of statistical significance only for the total and female cohorts. The Al levels, on the other hand, were positively and significantly associated with maternal serum Se levels in the total and male cohorts. However, Cd levels in blood were significantly correlated with Se levels in serum only in the total cohort.Results of univariate and multi-variable quantile regression at 50% are shown in In the multi-variable regression, maternal age, serum Zn, serum Cu, and race were associated with maternal Se levels. Compared to black Africans, study participants from other racial groups were more likely to have higher maternal Se levels . Additionally, the greater the maternal age, the higher the level of maternal Se .The current study has determined the Se status in utero at the delivery stage in a large cohort of pregnant women, residing along both the Indian and Atlantic Oceans coastal regions of South Africa. Highly significant differences in Se levels were found between the populations with participants from the rural Indian Ocean sites presenting with lower Se levels. This finding may indicate that some socio-economic, lifestyle, and dietary practices can be contributory factors. When compared with other studies, Se levels measured in our study were similar to those reported from Spain by Navarro et al. (1996) and those reported from Malawi and Ethiopia in pregnant populations ,46. On tStudies that have investigated Se levels at different stages of pregnancy have reported the lowest Se concentrations in the third trimester of pregnancy and at delivery. For example, Liu et al. (2017) showed that median Se levels in pregnant Chinese women declined from 77.6 µg/L in the first trimester to 65 µg/L in the third trimester .p < 0.001) as well as in the pre-term and full-term cohorts. Our literature review did not find any studies reporting an association between Se levels and neonate head circumference, suggesting the need for further investigation. No other effects of Se on birth outcomes were present in our study, although other researchers have reported an effect of Se on birth weight [To date, there are no published data on human Se levels in South Africa, but research has been conducted to investigate Se status in grazing herbivores. These studies report marginal to acute Se deficiencies in parts of the KwaZulu-Natal province and in the southern coastal region of the Western Cape province ; coincidh weight .Essential trace elements including Se regulate and maintain various organ systems in humans and their deficiency or excess may create a number of pathological conditions, particularly during the developmental stages. In South Africa, all women attending prenatal clinics are prescribed free supplements, but we have established that not all are actually taking supplements due to various traditional beliefs and social reasons. Our study found a significant positive correlation between maternal serum Se and the levels of the essential elements Zn and Cu in all cohorts. In contrast, some studies have found a negative correlation between Se and Zn in pregnant women, but significant positive correlations between maternal Se and Cu ,60. ThisThe protective role of Se in the exposure to environmental toxic elements was also evaluated in the current study. It is important to note that all toxic elements measured  were present in all samples and their concentrations were above the detection limits of the analytical instruments. In the total cohort, a significant negative correlation was found between maternal Se and Pb levels. It is reported that the competition between Se and Pb for binding with functional bio-ligands and/or in vivo formation of lead selenide are the protective mechanisms to consider . SimilarIn terms of an association with Al, the present study found a significant positive correlation with Se concentrations in the total and Atlantic Ocean cohorts. In a mouse animal model, a protective effect of Se on aluminum-induced oxidative stress in liver has been recently reported , and Se Evidence is growing for the establishment of sex-related differences in the response to prenatal exposure to environmental toxicants and dietary intake ,65. ThesIn the final univariate analysis model, the following parameters were positively associated with Se levels: living at the Atlantic Ocean site, increase in maternal age, and increased Cu, Zn, Hg, and Al concentrations. Head circumference and Pb level were negatively associated with Se levels. However, only the following parameters showed significant associations with Se in the multi-variable regression model: maternal age, Cu and Zn levels, and being of non-African ethnicity. In addition, Se levels were found to be positively associated with maternal age, as was also shown by other researchers who attributed this to a greater health awareness as one ages ,67.The current study investigated Se status at delivery as a measure of in utero access to selected essential trace elements, and exposure to certain toxic metals during gestation. To the best of our knowledge, this is the first study in South Africa that has evaluated Se status in the developmental stages, in a large cohort of delivering women. Our study found that Se levels were comparably lower than those reported from countries in the Northern Hemisphere, and negatively associated with head circumference of neonates, indicating the need for further investigation. Furthermore, this study has shown a significant correlation between Se and other essential trace elements such as Cu and Zn, which was also evident in the multi-variable regression model. Our study is also the first in South Africa to examine Se levels and sex-dependent responses in utero to both essential and toxic elements.The authors are aware that the present study has a number of limitations, one being reliance on participant memory for information on diet and lifestyle. Although every effort was made to obtain reliable information such as conducting interviews in the participants’ home language, there may still have been information bias due to misinterpretation, cultural misunderstanding, or poor recall. Another limitation is the fact that for practical and logistical reasons, all participants were recruited from government hospitals and no subjects were recruited from private hospitals, introducing an economic bias to the study. The cross-sectional design of the study was also a limiting factor. The study findings will form a baseline for further investigations in other areas of South Africa as well as in the rest of Africa; the findings may inform public health and regulatory agencies in formulating reproductive health policies.