Estimated fetal weight standards of the INTERGROWTH-21st project for the prediction of adverse outcomes: a systematic review with meta-analysis.

OBJECTIVE: To systematically review and assess the risk of bias in the literature evaluating the performance of INTERGROWTH-21st estimated fetal weight (EFW) standards to predict maternal, fetal and neonatal adverse outcomes. METHODS: Searches were performed in seven electronic databases (Scopus, Web of Science, Medline, Embase, Lilacs, Scielo and Google Scholar) using citation tools and keywords (intergrowth AND (standard OR reference OR formula OR model OR curve); all from 2014 to the last search on April 16th, 2021). We included full-text articles investigating the ability of INTERGROWTH-21st EFW standards to predict maternal, fetal or neonatal adverse outcomes in women with a singleton pregnancy who gave birth to infants with no congenital abnormalities. The study was registered on PROSPERO under the number CRD42020115462. Risk of bias was assessed with a customized instrument based on the CHARMS checklist and composed of 9 domains. Meta-analysis was performed using relative risk (RR [95%CI]) and summary ROC curves on outcomes reported by two or more methodologically homogeneous studies. RESULTS: Sixteen studies evaluating fifteen different outcomes were selected. The risk of bias was high (>50% of studies with high risk) for two domains: blindness of assessment (81.3%) and calibration assessment (93.8%). Considering all the outcomes investigated, for 95% of the results, the specificity was above 73.0%, but the sensitivity was below 64.1%. Pooled results demonstrated a higher RR of neonatal small for gestational age (6.71 [5.51-8.17]), Apgar <7 at 5 min (2.17 [1.48-3.18]), and neonatal intensive care unit admission (2.22 [1.76-2.79]) for fetuses classified <10th percentile when compared to those classified above this limit. The limitation of the study is the absence of heterogeneity exploration or publication bias investigation, whereas no outcomes were evaluated by more than five studies. CONCLUSIONS: The IG-21 EFW standard has low sensitivity and high specificity for adverse events of pregnancy. Classification <10th percentile identifies a high-risk group for developing maternal, fetal and neonatal adverse outcomes, especially neonatal small for gestational age, Apgar <7 at 5 min, and neonatal intensive care unit admission. Future studies should include blind assessment of outcomes, perform calibration analysis with continuous data, and evaluate alternative cutoff points.

Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies.

BACKGROUND: Journal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies' risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored. OBJECTIVE: We aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses. METHODS: Two independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework. RESULTS: The literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023. CONCLUSIONS: Our meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43537.

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial.

BACKGROUND: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol- and setting-related factors related to women's ineligibility and refusal to participate in the study. METHODS: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. RESULTS: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study. CONCLUSION: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03148483. Registered on 11 May 2017.

Sleep duration of 24 h is associated with birth weight in nulli- but not multiparous women.

OBJECTIVES: This study aimed to evaluate the association between nightly, napping, and 24-h sleep duration throughout pregnancy and birth weight z-score among nulli- and multiparous women. METHODS: Nightly,napping, and 24-h sleep duration and birth weight z-score (calculated on thebasis of the International Fetal and Newborn Growth Consortium for the 21st century standards) were studied in a cohort of 176 pregnant women from Brazil. Linear mixed-effect analyses were performed to assess the longitudinal evolution of sleep duration and the best unbiased linear predictors of the random coefficients were estimated. The best unbiased linear predictor estimates of sleep duration intercept and slope were included in the linear regression models with birth weight z-score as the outcome. RESULTS: The mean hours of nightly sleep decreased during pregnancy in nulliparous women (ß = -0.55; 95% confidence interval [CI], -0.83 to -0.27) but the decrease was not statistically significant in multiparous women (ß = -0.19; 95% CI, -0.30 to 0.01). Twenty-four hour sleep duration decreased during pregnancy in both multiparous (ß = -0.50; 95% CI, -0.76 to -0.25) and nulliparous women (ß = 0.77; 95% CI, -1.06 to -0.48). Napping sleep duration did not change in either group. Among the nulliparous women, both first-trimester 24-h sleep duration and its change throughout pregnancy were inversely associated with birth weight (ß = -0.44; 95% CI, -0.68 to -0.21; ß = -1.75; 95% CI, -3.17 to -0.30, respectively). No associations were detected in multiparous women for nightly and napping sleep duration. CONCLUSIONS: Nulliparous women with greater decreases in sleep duration throughout their pregnancy gave birth to newborns with lower birth weight z-scores.

Blood pressure in healthy pregnancy and factors associated with no mid-trimester blood pressure drop: a prospective cohort study.

BACKGROUND: The well-known mid-trimester drop in blood pressure (BP) during normal pregnancy was recently questioned. OBJECTIVE: To describe longitudinal changes in BP during healthy pregnancies and to investigate factors associated with no mid-trimester drop in BP. METHODS: A prospective cohort with 158 healthy pregnant women was followed up in a public health care center in Rio de Janeiro, Brazil. We used linear mixed-effects models to estimate longitudinal changes in systolic BP (SBP) and diastolic BP (DBP) during pregnancy. Poisson regression models were performed to identify factors associated with no mid-trimester drop in BP. RESULTS: Significant mid-trimester increase in SBP (5.6 mm Hg; 95% confidence interval (CI) = 4.6-6.7) and DBP (4.4 mm Hg; 95% CI = 3.4-5.3) was observed in 44.3% and 39.9% of the sample, respectively. Women (37.1%) who had not a mid-trimester SBP drop still had a DBP drop. White skin color (incidence ratio (IR): 1.71; 95% CI = 1.22-2.39), family history of hypertension (IR: 1.93; 95% CI = 1.29-2.89), early pregnancy obesity (IR: 2.29; 95% CI = 1.27-4.11), outside temperature variation (IR: 1.45; 95% CI = 1.00-2.10), and gestational weight gain from the first to second trimester (IR: 1.71; 95% CI = 1.01-2.88 and IR: 2.32; 95% CI = 1.39-3.89 for second and third tertiles) were characteristics associated with no mid-trimester drop in SBP. The same characteristics were associated with no mid-trimester drop in DBP, except family history of hypertension and outside temperature variation. CONCLUSIONS: Some women without a mid-trimester SBP drop still present a DBP drop. The different patterns of mid-trimester change in BP seem to be determined by preexisting and pregnancy-related factors.

Total cholesterol and leptin concentrations are associated with prospective changes in systemic blood pressure in healthy pregnant women.

BACKGROUND: Lipids and leptin have been associated with high blood pressure (BP) levels during pregnancy. The aim was to evaluate the associations between serum lipids and leptin concentrations during the first trimester and longitudinal changes of SBP and DBP in healthy pregnancies. METHODS: Prospective cohort of pregnant women followed at a public healthcare center in Rio de Janeiro, Brazil. SBP and DBP were obtained at the ≤13th, 20-26th, and 30-36th weeks of gestation and were the dependent variables. Serum lipids and plasma leptin concentrations were collected at 13 weeks or less of gestation and were the main independent variables. Statistical analyses included longitudinal linear mixed-effects regression models, with (ß) coefficients and their 95% confidence intervals (CI). RESULTS: Mean BPs were 109.8/66.9, 107.8/64.3, and 111.2/66.9  mmHg, respectively in the 1st, 2nd, and 3rd trimester. Multiple longitudinal regressions revealed that leisure time physical activity before pregnancy (ß(SBP) = -3.003, 95% CI = -5.034 to -0.971; ß(DBP) = -2.620, 95% CI = -4.177 to -1.064), baseline BMI (ß(SBP) = 4.003, 95% CI = 1.924-6.081; ß(DBP) = 1.862, 95% CI = 0.252-3.412), parity (ß(SBP) = -2.778, 95% CI = -4.627 to -0.929; ß(DBP) = -1.780, 95% CI = -3.168 to -0.392), and Homeostasis model of assessment-Insulin Resistance (HOMA-IR; ß(SBP) = 2.554, 95% CI = 0.552-4.557; ß(DBP) = 2.962, 95% CI = 1.436-4.489) were the covariates independently associated with SBP and DBP changes. Monthly per-capita family income (ß(SBP) = -0.006, 95% CI = -0.010 to -0.001), total cholesterol (ß(SBP) = 2.094, 95% CI = 0.223-3.965), and leptin (ß(SBP) = 2.211, 95% CI = 0.159-4.263) were associated only with SBP changes. CONCLUSION: Serum total cholesterol and leptin concentrations, HOMA-IR, and BMI were positively associated with changes in BP during healthy pregnancies, whereas physical activity, parity, and family income were negatively associated.

C-reactive protein and later preeclampsia: systematic review and meta-analysis taking into account the weight status.

OBJECTIVES: This study aims to determine whether high C-reactive protein (CRP) concentration during pregnancy is associated with later preeclampsia and whether weight status (BMI) is a potential modifier of the relation between CRP and preeclampsia. METHODS: Twenty-three studies were included in a systematic literature review and a subset of 18 in a meta-analysis. Weighted mean difference (WMD) [with their 95% confidence intervals (CI)] of CRP in preeclampsia and control groups was the estimator. A quality assessment was carried out using a scale specifically developed for this study. Meta-regression with estimates for study characteristics and inter-arm differences and sensitivity and subgroup analysis was employed. Statistical heterogeneity was investigated using I(2) statistic. RESULTS: The pooled estimated CRP between 727 women, who developed preeclampsia and 3538 controls was 2.30 mg/l (95% CI: 1.27-3.34). The heterogeneity among studies was high (I(2) = 92.8). The WMD was found to be lower in studies comprising preeclampsia and control groups with similar BMI [WMD = 0.85 (95% CI: 0.10-1.61); I(2) = 25.3%] compared with studies among which BMI was significantly elevated in the preeclampsia group [2.01 (95% CI: 1.23-2.78); I(2) = 0.0%], which may explain the high heterogeneity of pooled data. Meta-regression results confirmed that difference in BMI between groups modifies the association of CRP and preeclampsia. High quality studies represented 30%. CONCLUSION: The pooled WMD suggest that women with higher levels of CRP may have an increased risk of developing preeclampsia. This association seems to be modified by confounders, such as BMI. Further studies of high methodological quality are needed.

Household food insecurity is not associated with BMI for age or weight for height among Brazilian children aged 0-60 months.

We examined the association between Household Food Insecurity (HFI), weight for height z-score (WHZ) and Body Mass Index for age z-score (BMI-Z) in a representative sample of children 0-60 months of age (n = 3,433) in five Brazilian geographical regions. Data were derived from the 2006-07 Brazilian Demographic and Health Survey. HFI was measured with the Brazilian Food Insecurity Scale. Associations were estimated using multiple linear regression models (ß coefficients and 95% CI) taking into account the complex sampling design. Interaction terms between HFI and geographical region and HFI and child sex and child age were assessed. The weighted prevalence of any level of HFI was 48.6%. Severe food insecurity was more prevalent among children from the North region (16.8%), born from mothers with <4 years of schooling (15.9%) and those from families with ≥3 children (18.8%). The interaction between HFI and geographical region was non-significant for BMI-Z (P = 0.119) and WHZ (P = 0.198). Unadjusted results indicated that HFI was negatively associated with BMI-Z (moderate to severe HFI: ß = -0.19, 95% CI: -0.35 - -0.03, P = 0.047), and WHZ (moderate to severe HFI: ß = -0.26, 95% CI: -0.42 - -0.09, P = 0.009). Estimates lost significance after adjustments for key confounders such as mothers' skin color, mothers' years of schooling, place of household, household income quartiles, mothers' smoking habit, mothers' marital status, number of children 0-60 months in the household, and birth order. HFI is unrelated to weight outcomes among Brazilian children 0-60 months.

Severe food insecurity is associated with obesity among Brazilian adolescent females.

OBJECTIVE: To determine whether household food insecurity (HFI) is associated with a higher prevalence of excessive weight (EW) in a large random sample of Brazilian female adolescents. DESIGN: Nationally representative cross-sectional study. EW was the outcome variable (BMI ≥ 85th percentile of WHO reference for adolescents aged 15-18 years and BMI ≥ 25 kg/m(2) for those aged 19 years). HFI was measured with the Brazilian Food Insecurity Scale. Associations were measured using crude and adjusted prevalence ratios (PR) with 95 % confidence intervals through Poisson regression models taking into account the complex sampling design. SETTING: Data were derived from the third wave of the Demographic and Health Survey conducted in 2006-2007, in Brazil. SUBJECTS: The sample included 1529 female adolescents aged 15-19 years. RESULTS: The prevalence of any level of HFI was 40.8 %, with 26.6 % of households experiencing mild, 9.4 % moderate and 4.8 % severe food insecurity. The overall prevalence of EW was 21.9 % (12.9 % were overweight and 9.0 % obese). EW prevalence among those living in severely, moderately and mildly food-insecure households was 36.8 %, 14.9 % and 16.5 %, respectively (P for the overall association = 0.036). Women living in severely food-insecure households had an increased prevalence of EW compared with their food-secure counterparts (PR = 1.96; 95 % CI 1.18, 3.27; P = 0.007), after adjusting for important confounders. CONCLUSIONS: The study suggests that severe but not mild or moderate HFI is independently associated with EW among adolescents residing in Brazil, a middle-income country undergoing the nutrition transition.

Mild but not light or severe food insecurity is associated with obesity among Brazilian women.

Our aim was to determine whether food insecurity was associated with a higher prevalence of obesity in a large random sample of Brazilian women of reproductive age. The data were derived from the 3rd edition of the Children's and Women's National Demographic and Health Survey conducted in 2006-07. This was a nationally representative cross-sectional study. Obesity (BMI ≥ 30 kg/m(2)) was the outcome variable. Associations were measured using crude and adjusted prevalence ratios (PR) with 95% CI through Poisson regression models taking into account the complex sampling design. The sample included 10,226 women from 18 to 45 y of age. The prevalence of any level of food insecurity measured by the Brazilian Food Insecurity Scale was 40.9%, with 25.5% light, 10.1% mild, and 5.3% severe food insecurities. The prevalence of obesity was 17.4%. We found a borderline effect of light food insecurity and increased prevalence of obesity in Brazil (PR = 1.16; 95% CI = 0.98-1.38; P = 0.08). Women with mild food insecurity had a higher risk of being obese than their food-secure counterparts (PR = 1.49; 95% CI = 1.17-1.90; P = 0.010) after adjustment for skin color/ethnicity, years of schooling, geographical region, income, age, and marital status. In conclusion, this study suggests that mild but not light or severe food insecurity was associated with obesity as assessed by BMI, even after adjusting for various confounding factors in this large cross-sectional survey performed in a middle-income country undergoing the nutrition transition.

Fatores associados à retenção de peso pós-parto em uma coorte de mulheres, 2005-2007 / Factors associated with post-partum weight retention in a cohort of women, 2005-2007

OBJETIVO: investigar fatores associados à retenção de peso pós-parto. MÉTODOS: estudo de coorte com 104 gestantes recrutadas em uma Unidade Básica de Saúde no município do Rio de Janeiro, da 8ª a 13ª semana de gestação e acompanhadas até aproximadamente 55 dias pós-parto. As variáveis incluíram informações sócio-demográficas, econômicas, bioquímicas, antropométricas e reprodutivas. A retenção de peso pós-parto (diferença entre o peso pós-parto e o peso pré-gestacional) foi utilizada como variável dependente. RESULTADOS: a média de peso retido foi 3,2 kg ± 3,7 kg. As mulheres com ganho de peso gestacional (GPG) excessivo retiveram 5,0 kg ± 3,9 em comparação a 3,6 kg ± 3,0 em mulheres com GPG adequado e 1,4 kg ± 3,1 para as com GPG insuficiente. O GPG e o Índice de Massa corporal (IMC) pré-gestacional mantiveram associação significativa com a retenção de peso no modelo final. Observou-se que a cada quilo de peso ganho na gestação, quase 50 por cento ficaram retidos no pós-parto (β = 0,494; p<0,001) e a cada 1,0 kg/m² a menos no IMC pré-gestacional correspondeu a uma retenção de aproximadamente 150g (β = -0,149;p<0,05). CONCLUSÃO: o GPG está positivamente e o IMC pré-gestacional inversamente associado à retenção de peso pós-parto. Orientações nutricionais sobre o controle do ganho ponderal podem ajudar a minimizar a incidência de obesidade entre mulheres no pós-parto.

OBJECTIVE: to investigate factors associated with post-partum weight retention. METHODS: a cohort study with 104 recruited pregnant women in the 8th to 13th week of gestation was carried out at Basic Health Unit in the municipality of Rio de Janeiro and the women were accompanied until around 55 days post-partum. The variables included socio-demographic, economic, biochemical, anthropometric and reproductive data. Post-partum weight retention (the difference between postpartum andpre-gestational weight) was used as the dependent variable. RESULTS: the mean weight retention was 3.2 kg ± 3.7 kg. Women with excessive gestational weight gain retained 5.0 kg ± 3.9 in comparison to 3.6 kg ± 3.0 in women with adequate gestational weight gain and 1.4 kg ± 3.1 compared to those with inadequate gestational weight gain. The gestational weight gain and pre-gestational body mass index continued to show a significant association with weight retention in the final model. It was found that for every kilogram of weight gain during gestation, almost 50 percent was retained post-partum (β = 0.494; p<0.001) and every 1.0 kg/m² less in pre-gestational BMI corresponded to a retention of approximately 150g (β = -0.149; p<0.05). CONCLUSION: gestational weight gain is positively associated with post-partum weight retention, while pre-gestational BMI is inversely associated with the dependent variable. Nutritional advice on weight control may help minimize the incidence of obesity in women during post-partum.