Normative ranges of biventricular volumes and function in healthy term newborns.

BACKGROUND: Cardiovascular magnetic resonance (CMR) is increasingly used in newborns with congenital heart disease. However, reporting on ventricular volumes and mass is hindered by an absence of normative data in this population. DESIGN/METHODS: Healthy term (37-41 weeks gestation) newborns underwent non-sedated, free-breathing CMR within the first week of life using the 'feed and wrap' technique. End-diastolic volume (EDV), end-systolic volume (ESV) stroke volume (SV) and ejection fraction (EF) were calculated for both left ventricle (LV) and right ventricle (RV). Papillary muscles were separately contoured and included in the myocardial volume. Myocardial mass was calculated by multiplying myocardial volume by 1.05 g/ml. All data were indexed to weight and body surface area (BSA). Inter-observer variability (IOV) was performed on data from 10 randomly chosen infants. RESULTS: Twenty healthy newborns (65% male) with a mean (SD) birth weight of 3.54 (0.46) kg and BSA of 0.23 (0.02) m2 were included. Normative LV parameters were indexed EDV 39.0 (4.1) ml/m2, ESV 14.5 (2.5) ml/m2 and ejection fraction (EF) 63.2 (3.4)%. Normative RV indexed EDV, ESV and EF were 47.4 (4.5) ml/m2, 22.6 (2.9) ml/m2 and 52.5 (3.3)% respectively. Mean LV and RV indexed mass were 26.4 (2.8) g/m2 and 12.5 (2.0) g/m2, respectively. There was no difference in ventricular volumes by gender. IOV was excellent with an intra-class coefficient > 0.95 except for RV mass (0.94). CONCLUSION: This study provides normative data on LV and RV parameters in healthy newborns, providing a novel resource for comparison with newborns with structural and functional heart disease.

Antenatal detection of large-for-gestational-age fetuses following implementation of the Growth Assessment Protocol: secondary analysis of a randomised control trial.

OBJECTIVE: To determine whether the Growth Assessment Protocol (GAP) affects the antenatal detection of large for gestational age (LGA) or maternal and perinatal outcomes amongst LGA babies. DESIGN: Secondary analysis of a pragmatic open randomised cluster control trial comparing the GAP with standard care. SETTING: Eleven UK maternity units. POPULATION: Pregnant women and their LGA babies born at ≥36+0  weeks of gestation. METHODS: Clusters were randomly allocated to GAP implementation or standard care. Data were collected from electronic patient records. Trial arms were compared using summary statistics, with unadjusted and adjusted (two-stage cluster summary approach) differences. MAIN OUTCOME MEASURES: Rate of detection of LGA (estimated fetal weight on ultrasound scan above the 90th centile after 34+0  weeks of gestation, defined by either population or customised growth charts), maternal and perinatal outcomes (e.g. mode of birth, postpartum haemorrhage, severe perineal tears, birthweight and gestational age, neonatal unit admission, perinatal mortality, and neonatal morbidity and mortality). RESULTS: A total of 506 LGA babies were exposed to GAP and 618 babies received standard care. There were no significant differences in the rate of LGA detection (GAP 38.0% vs standard care 48.0%; adjusted effect size -4.9%; 95% CI -20.5, 10.7; p = 0.54), nor in any of the maternal or perinatal outcomes. CONCLUSIONS: The use of GAP did not change the rate of antenatal ultrasound detection of LGA when compared with standard care.

Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial.

BACKGROUND: Antenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care. METHODS AND FINDINGS: This was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight <10th centile using customised centiles (intervention) or Hadlock centiles (standard care)) confirmed at birth (birthweight <10th centile by both customised and population centiles). Secondary outcomes were maternal and neonatal outcomes, including induction of labour, gestational age at delivery, mode of birth, neonatal morbidity, and stillbirth/perinatal mortality. A 2-stage cluster-summary statistical approach calculated the absolute difference (intervention minus standard care arm) adjusted using the prerandomisation estimate, maternal age, ethnicity, parity, and randomisation strata. Intervention arm clusters that made no attempt to implement GAP were excluded in modified intention to treat (mITT) analysis; full ITT was also reported. Process evaluation assessed implementation fidelity, reach, dose, acceptability, and feasibility. Seven clusters were randomised to GAP and 6 to standard care. Following exclusions, there were 11,096 births exposed to the intervention (5 clusters) and 13,810 exposed to standard care (6 clusters) during the outcome period (mITT analysis). Age, height, and weight were broadly similar between arms, but there were fewer women: of white ethnicity (56.2% versus 62.7%), and in the least deprived quintile of the Index of Multiple Deprivation (7.5% versus 16.5%) in the intervention arm during the outcome period. Antenatal detection of SGA was 25.9% in the intervention and 27.7% in the standard care arm (adjusted difference 2.2%, 95% confidence interval (CI) -6.4% to 10.7%; p = 0.62). Findings were consistent in full ITT analysis. Fidelity and dose of GAP implementation were variable, while a high proportion (88.7%) of women were reached. Use of routinely collected data is both a strength (cost-efficient) and a limitation (occurrence of missing data); the modest number of clusters limits our ability to study small effect sizes. CONCLUSIONS: In this study, we observed no effect of GAP on antenatal detection of SGA compared to standard care. Given variable implementation observed, future studies should incorporate standardised implementation outcomes such as those reported here to determine generalisability of our findings. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry, ISRCTN67698474.

Lifestyle intervention in obese pregnancy and cardiac remodelling in 3-year olds: children of the UPBEAT RCT.

BACKGROUND/OBJECTIVES: Obesity in pregnancy has been associated with increased childhood cardiometabolic risk and reduced life expectancy. The UK UPBEAT multicentre randomised control trial was a lifestyle intervention of diet and physical activity in pregnant women with obesity. We hypothesised that the 3-year-old children of women with obesity would have heightened cardiovascular risk compared to children of normal BMI women, and that the UPBEAT intervention would mitigate this risk. SUBJECTS/METHODS: Children were recruited from one UPBEAT trial centre. Cardiovascular measures included blood pressure, echocardiographic assessment of cardiac function and dimensions, carotid intima-media thickness and heart rate variability (HRV) by electrocardiogram. RESULTS: Compared to offspring of normal BMI women (n = 51), children of women with obesity from the trial standard care arm (n = 39) had evidence of cardiac remodelling including increased interventricular septum (IVS; mean difference 0.04 cm; 95% CI: 0.018 to 0.067), posterior wall (PW; 0.03 cm; 0.006 to 0.062) and relative wall thicknesses (RWT; 0.03 cm; 0.01 to 0.05) following adjustment. Randomisation of women with obesity to the intervention arm (n = 31) prevented this cardiac remodelling (intervention effect; mean difference IVS -0.03 cm (-0.05 to -0.008); PW -0.03 cm (-0.05 to -0.01); RWT -0.02 cm (-0.04 to -0.005)). Children of women with obesity (standard care arm) compared to women of normal BMI also had elevated minimum heart rate (7 bpm; 1.41 to 13.34) evidence of early diastolic dysfunction (e prime) and increased sympathetic nerve activity index by HRV analysis. CONCLUSIONS: Maternal obesity was associated with left ventricular concentric remodelling in 3-year-old offspring. Absence of remodelling following the maternal intervention infers in utero origins of cardiac remodelling. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The UPBEAT trial is registered with Current Controlled Trials, ISRCTN89971375.

Performances of birthweight charts to predict adverse perinatal outcomes related to SGA in a cohort of nulliparas.

BACKGROUND: Small-for-gestational-age neonates (SGA) are at increased risk of neonatal morbidity. Nulliparity represents a risk factor for SGA; birthweight charts may perform differently for the detection of SGA among nulliparas. This study aimed at describing the prevalence of SGA in nulliparas according to different birthweight charts and evaluating the diagnostic performance of these charts to maternal and perinatal outcomes. METHODS: This is a secondary analysis of a Brazilian cohort of nulliparas named Preterm SAMBA study. Birthweight centiles were calculated using the Intergrowth-21st, WHO-Fetal Growth Charts, Birth in Brazil population chart and GROW-customised chart. The risks of outcomes among SGA neonates and their mothers in comparison to neonates with birthweights between the 40th-60th centiles were calculated, according to each chart. ROC curves were used to detect neonatal morbidity in neonates with birth weights below different cutoff centiles for each chart. RESULTS: A sample of 997 nulliparas was assessed. The rate of SGA infants varied between 7.0-11.6%. All charts showed a significantly lower risk of caesarean sections in women delivering SGA neonates compared to those delivering adequate-for-gestational-age neonates (OR 0.55-0.64, p < .05). The charts had poor performance (AUC 0.492 - 0.522) for the detection of neonatal morbidity related to SGA born at term. CONCLUSION: The populational and customised birthweight charts detected different prevalence of small-for-gestational-age neonates and showed similar and poor performance to identify related neonatal adverse outcomes in this population.

The relation between maternal obesity and placenta accreta spectrum: A multinational database study.

INTRODUCTION: It has been suggested that women with obesity have increased risk of developing placenta accreta spectrum (PAS). It is unclear if this is independent of the increased risk of cesarean delivery seen with obesity itself. The aim of this study was to explore the association between maternal obesity and PAS, particularly severe PAS (percreta). MATERIAL AND METHODS: This is a cohort study based on cases recorded in the International Society for Placenta Accreta Spectrum (IS-PAS) database between April 2008 and May 2019. Multivariable logistic regression was used to explore the effect of maternal obesity on severity of PAS; this model was adjusted for other known risk factors including previous cesarean deliveries, maternal age, and placenta previa. The estimated rate of obesity in a hypothetical cohort with similar characteristics (previous cesarean delivery and same parity) was calculated and compared with the observed rate of obesity in the women of the PAS cohort (one sample test of proportions). RESULTS: Of the 386 included women with PAS, 227 (58.8%) had severe disease (percreta). In univariable analysis, maternal obesity initially appeared to be associated with increased odds of developing the most severe type of PAS, percreta (odds ratio [OR] 1.87; 95% CI 1.14-3.09); however, this association was lost after adjustment for other risk factors including previous cesarean delivery (OR 1.44; 95% CI 0.85-2.44). There was no difference in the observed rate of obesity and the rate estimated based on the risk of cesarean delivery from obesity alone (31.3% vs 36.8%, respectively; P = .07). CONCLUSIONS: Obesity does not seem to be an independent risk factor for PAS or severity for PAS. These findings are relevant for clinicians to provide accurate counseling to women with obesity regarding increased risks related to pregnancy.

Characteristics associated with uncomplicated pregnancies in women with obesity: a population-based cohort study.

BACKGROUND: Approximately one in five pregnant women have obesity. Obesity is associated with an increased risk of antenatal, intrapartum, and perinatal complications, but many women with obesity have uncomplicated pregnancies. At a time where maternity services are advocating for women to make informed choices, knowledge of the chance of having an uncomplicated (healthy) pregnancy is essential. The objective of this study was to calculate the rate of uncomplicated pregnancy in women with obesity and evaluate factors associated with this outcome. METHODS: This prospective cohort study was conducted using the Ontario birth registry dataset in Canada (703,115 women, April 2012-March 2017). The rate of uncomplicated or complicated composite pregnancy outcomes (hypertensive disorders of pregnancy, gestational diabetes, preterm birth, neonate small- or large- for gestational age at birth, congenital anomaly, fetal death, antepartum bleeding or preterm prelabour membrane rupture) were calculated for women with and without obesity. Associations between uncomplicated pregnancy and maternal characteristics were explored in a population of women with obesity but without other pre-existing co-morbidities (e.g., essential hypertension) or obstetric risks identified in the first trimester (e.g., multiple pregnancy), using log binomial regression analysis. RESULTS: Of the studied Ontario maternity population (body mass index not missing) 17·7% (n = 117,236) were obese. Of these 20·6% had pre-existing co-morbidities or early obstetric complicating factors. Amongst women with obesity but without early complicating factors, 58·2% (n = 54,191) experienced pregnancy without complication; this is in comparison to 72·7% of women of healthy weight and no early complicating factors. Women with obesity and no early pregnancy complicating factors are more likely to have an uncomplicated pregnancy if they are multiparous, younger, more affluent, of White or Black ethnicity, of lower weight, with normal placental-associated plasma protein-A and/or spontaneously conceived pregnancies. CONCLUSIONS: The study demonstrates that over half of women with obesity but no other pre-existing medical or early obstetric complicating factors, proceed through pregnancy without adverse obstetric complication. Care in lower-risk settings can be considered as their outcomes appear similar to those reported for low-risk nulliparous women. Further research and predictive tools are needed to inform stratification of women with obesity.

Determination of birth-weight centile thresholds associated with adverse perinatal outcomes using population, customised, and Intergrowth charts: A Swedish population-based cohort study.

BACKGROUND: Although many studies have compared birth-weight charts to determine which better identify infants at risk of adverse perinatal outcomes, less attention has been given to the threshold used to define small or large for gestational age (SGA or LGA) infants. Our aim was to explore different thresholds associated with increased risk of adverse perinatal outcomes using population, customised, and Intergrowth centile charts. METHODS AND FINDINGS: This is a population-based cohort study (Swedish Medical Birth Registry), which included term singleton births between 2006 and 2015 from women with available data on first-trimester screening. Population, customised, and Intergrowth charts were studied. Outcomes included cesarean section, postpartum haemorrhage, severe perineal tear, Apgar score at 5 minutes, neonatal morbidity, and perinatal mortality. Odds for each outcome were assessed in intervals of 5 centiles of birth weight (reference being 40th-60th centiles) using logistic regression. Intervals of 5% of the population were also explored. Sensitivity for fixed false-positive rates (FPRs) was reported for neonatal outcomes. Data from 212,101 births were analysed. Mean age was 33 ± 5 years, 48% of women were nulliparous, and 80% were born in Sweden. Prevalence of SGA (<10th centile) was 10.1%, 10.0%, and 3.1%, and prevalence of LGA (>90th centile) was 10.0%, 8.2%, and 25.1%, assessed using population, customised, and Intergrowth charts, respectively. In small infants, the risk of perinatal mortality was consistently increased below the 15th, 10th, and 35th birth-weight centiles for the respective charts (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.05-2.39, p = 0.03 for 10th-15th population centile; OR 2.54, 95% CI 1.74-3.71, p < 0.001 for 5th-10th customised centile; OR 1.81, 95% CI 1.07-3.04, p = 0.03 for 30th-35th Intergrowth centile). The strength of association with adverse perinatal outcomes was different between infants below the 5th birth-weight centile for each chart (OR 4.47, 95% CI 3.30-6.04, p < 0.001 for the population chart; OR 5.78, 95% CI 4.22-7.91, p < 0.001 for the customised chart; OR 10.74, 95% CI 7.32-15.77, p < 0.001 for the Intergrowth chart) but similar in the smallest 5% of the population (OR 4.34, 95% CI 3.22-5.86, p < 0.001 for the population chart; OR 5.23, 95% CI 3.85-7.11, p < 0.001 for the customised chart; OR 4.69, 95% CI 3.47-6.34, p < 0.001 for the Intergrowth chart). For a fixed FPR of 10%, different thresholds for each chart achieved similar sensitivity for perinatal mortality in small infants (29% for all charts). Similar behaviour of different thresholds and similar risk/sensitivity for fixed FPR were observed in relation to other outcomes and for LGA infants. Limitations of this study include the relative homogeneity of the Swedish population, which limits generalisability to other populations; customised centiles may perform differently in populations with increased heterogeneity of ethnic background. CONCLUSIONS: The risk of adverse outcomes was consistent across proportions of the population but did not reflect fixed thresholds, such as the 10th or 90th centiles, across different growth charts. Chart-specific thresholds for the population should be considered in clinical practice.

Antenatal risk factors associated with neonatal morbidity in large-for-gestational-age infants: an international prospective cohort study.

INTRODUCTION: Large-for-gestational-age infants are associated with increased risk of neonatal morbidity and mortality. However, most of them will not have adverse outcomes. Our aim was to identify antenatal clinical factors associated with neonatal morbidity in large-for-gestational-age infants. MATERIAL AND METHODS: Nulliparous women from the Screening for Pregnancy Endpoints (SCOPE) study were included. We compared maternal and fetal factors between large-for-gestational-age infants (birthweight >90th customized centile) with and without neonatal morbidity, defined as admission to a neonatal intensive care unit or severe neonatal morbidity. Factors were selected based on a priori hypotheses of association and included maternal demography, anthropometric measures and self-reported physical activity (15 and 20 weeks), fetal biometry (20 weeks), and clinical information. Multivariable logistic regression was used to identify risk factors. Stratified analyses were performed by maternal obesity and physical activity. RESULTS: Among term pregnancies, prevalence of large-for-gestational-age infants was 9.3% (491/5255), with 11.8% (58/491) prevalence of neonatal morbidity. Random glucose at 20 weeks (odds ratio 1.52; 95% confidence interval 1.17-1.97, per 1 mmol/L increase) and no regular physical activity at 20 weeks (odds ratio 3.93; 95% confidence interval 1.75-8.83) were associated with increased risk of neonatal morbidity after adjustment for birthweight, gestational age at delivery and gestational diabetes. The increased risk associated with higher glucose levels was not evident in women with regular physical activity or without obesity. CONCLUSIONS: Regular physical activity in mid-pregnancy is associated with lower risk for neonatal morbidity in large-for-gestational-age infants and seems to offer protection against the increased risk associated with higher maternal glucose levels.

Prediction of uncomplicated pregnancies in obese women: a prospective multicentre study.

BACKGROUND: All obese pregnant women are considered at equal high risk with respect to complications in pregnancy and birth, and are commonly managed through resource-intensive care pathways. However, the identification of maternal characteristics associated with normal pregnancy outcomes could assist in the management of these pregnancies. The present study aims to identify the factors associated with uncomplicated pregnancy and birth in obese women, and to assess their predictive performance. METHODS: Data form obese women (BMI ≥ 30 kg/m2) with singleton pregnancies included in the UPBEAT trial were used in this analysis. Multivariable logistic regression was used to identify sociodemographic, clinical and biochemical factors at 15+0 to 18+6 weeks' gestation associated with uncomplicated pregnancy and birth, defined as delivery of a term live-born infant without antenatal or labour complications. Predictive performance was assessed using area under the receiver operating characteristic curve (AUROC). Internal validation and calibration were also performed. Women were divided into fifths of risk and pregnancy outcomes were compared between groups. Sensitivity, specificity, and positive and negative predictive values were calculated using the upper fifth as the positive screening group. RESULTS: Amongst 1409 participants (BMI 36.4, SD 4.8 kg/m2), the prevalence of uncomplicated pregnancy and birth was 36% (505/1409). Multiparity and increased plasma adiponectin, maternal age, systolic blood pressure and HbA1c were independently associated with uncomplicated pregnancy and birth. These factors achieved an AUROC of 0.72 (0.68-0.76) and the model was well calibrated. Prevalence of gestational diabetes, preeclampsia and other hypertensive disorders, preterm birth, and postpartum haemorrhage decreased whereas spontaneous vaginal delivery increased across the fifths of increasing predicted risk of uncomplicated pregnancy and birth. Sensitivity, specificity, and positive and negative predictive values were 38%, 89%, 63% and 74%, respectively. A simpler model including clinical factors only (no biomarkers) achieved an AUROC of 0.68 (0.65-0.71), with sensitivity, specificity, and positive and negative predictive values of 31%, 86%, 56% and 69%, respectively. CONCLUSION: Clinical factors and biomarkers can be used to help stratify pregnancy and delivery risk amongst obese pregnant women. Further studies are needed to explore alternative pathways of care for obese women demonstrating different risk profiles for uncomplicated pregnancy and birth.

Maternal diet and interactions with nutritional evaluation during pregnancy.

This narrative review aims to describe the knowledge regarding nutritional evaluation and monitoring in pregnant women. We discuss care provided by non-specialists in nutrition, regarding dietary information and risks during pregnancy, from a theoretical or conceptual viewpoint. A narrative review was conducted following a literature search when scientific databases were investigated, including SciELO, LILACS, Medline, PubMed, theses, government reports, books, and chapters in books. Finally, the material was fully read, categorized, and critically analyzed. National and international protocols of prenatal nutritional care were included and discussed. Different protocols describe the complexity of evaluating and monitoring nutrition among pregnant women during the prenatal period according to each country. The understanding of social conditions and eating habits has an important role in providing nutritional advice during pregnancy. The lack of dietitians in care overwhelms the healthcare workers and characterizes a missed opportunity. Therefore, it is important to consider rapid support tools that can track adverse nutritional status, and ways to recommend a diet that meets eating habit dynamics, according to the reality of each public health system.

A conceptual framework for nutritional evaluation, screening, and monitoring of pregnant women: Evidence from a Brazilian cohort of nulliparous women.

The present review comes from five previous studies of a multicenter cohort of nulliparous pregnant women from different regions of Brazil. The first study showed a wide difference in consumption of industrialized foods among women from the south and southeast regions compared with northeastern women who chose to eat a healthier diet with fresh natural food. The second investigation intended to understand maternal eating habits, where five dietary patterns were identified: two considered healthy and three with excess protein, ultra-processed foods, fats, and sweets. Considering some barriers to classifying nutrition status during prenatal care, when data on pre-pregnancy weight is unknown, the third study developed a tool to identify three levels of risk for each gestational age range, assessed by measuring arm circumference. Applying those new tools, the associations between maternal nutrition and pregnancy outcomes were investigated: prematurity, pre-eclampsia, gestational diabetes mellitus, and small-for-gestational-age infants. From these analyses, a predictive model was developed indicating that obesity, non-white color, and dietary pattern with excess protein consumption were associated with a greater probability of adverse pregnancy outcomes. Moreover, the potential of the intergenerational influence of head circumference as a proxy for maternal nutrition was analyzed. Using a Path Analysis method, the model was evidenced by different socioeconomic variables. Finally, understanding the complexity of the nutritional assessment, the present conceptual framework was proposed for nutritional assessment, and tracking and monitoring of pregnant women.

Investigation of stillbirths in Brazil: A systematic scoping review of the causes and related reporting processes in the past decade.

BACKGROUND: Recognizing the causes of stillbirths and their associated conditions is essential to reduce its occurrence. OBJECTIVE: To describe information on stillbirths in Brazil during the past decade. SEARCH STRATEGY: A literature search was performed from January 2010 to December 2020. SELECTION CRITERIA: Original observational studies and clinical trials. DATA COLLECTION AND ANALYSIS: Data were manually extracted to a spreadsheet and descriptive analysis was performed. RESULTS: A total of 55 studies were included; 40 studies (72.2%) used the official data stored by national public health systems. Most articles aimed to estimate the rate and trends of stillbirth (60%) or their causes (55.4%). Among the 16 articles addressing the causes of death, 10 (62.5%) used the International Classification of Diseases; most of the articles only specified the main cause of death. Intrauterine hypoxia was the main cause reported (ranging from 14.3% to 54.9%). CONCLUSION: Having a national system based on compulsory notification of stillbirths may not be sufficient to provide quality information on occurrence and, especially, causes of death. Further improvements of the attribution and registration of causes of deaths and the implementation of educational actions for improving reporting systems are advisable. Finally, expanding the investigation of contributing factors associated with stillbirths would create an opportunity for further development of prevention strategies in low- and middle-income countries such as Brazil.

Profile of calories and nutrients intake in a Brazilian multicenter study of nulliparous women.

OBJECTIVE: To assess the calorie intake and nutritional content of the maternal diet in regions with different culinary traditions and typical foods, and to understand the nutritional profile so as to provide information about the consumption of this population and promote maternal and perinatal health. METHODS: From a cohort of 1145 pregnant women with diverse socio-backgrounds we analyzed the dietary characteristics profile according to three guidelines and compared the differences between regions of Brazil. RESULTS: Women from the northeast had the lowest level of income, occupation, education, and age (P < 0.001). Intakes of unprocessed/minimally processed foods and processed foods were more prevalent in women from the northeast than in southern/southeastern women (P < 0.001). The consumption of dairy products and vegetables was less than the recommended intake, with lower intake in southern/southeastern women (P < 0.001). This study showed a lower consumption of dairy and vegetables, with a shortfall of vitamins K and D, iron, calcium, folate, magnesium, and chromium from natural and fortified foods. We observed a greater consumption of unprocessed or minimally processed food in women from the northeast of Brazil. CONCLUSION: Our findings indicate the importance of differentiating the source of calorie intake between regional nutritional guidance and the diversity of local cuisine.

Head circumference as an epigenetic risk factor for maternal nutrition.

Nutrition indicators for malnutrition can be screened by many signs such as stunting, underweight or obesity, muscle wasting, and low caloric and nutrients intake. Those deficiencies are also associated with low socioeconomic status. Anthropometry can assess nutritional status by maternal weight measurements during pregnancy. However, most studies have focused primarily on identifying changes in weight or Body Mass Index (BMI), and their effects on neonatal measures at present time. Whereas head circumference (HC) has been associated with nutrition in the past. When the mother was exposed to poor nutrition and unfavorable social conditions during fetal life, it was hypothesized that the intergenerational cycle was potentially mediated by epigenetic mechanisms. To investigate this theory, maternal head circumference (MHC) was associated with neonatal head circumference (NHC) in pregnant women without preexisting chronic conditions, differentiated by sociodemographic characteristics. A multiple linear regression model showed that each 1 cm-increase in MHC correlated with a 0.11 cm increase in NHC (ß95% CI 0.07 to 0.15). Notwithstanding, associations between maternal and neonatal anthropometrics according to gestational age at birth have been extensively explained. Path analysis showed the influence of social status and the latent variable was socioeconomic status. A model of maternal height and head circumference was tested with effects on neonatal HC. The social variable lacked significance to predict neonatal HC in the total sample (p = 0.212) and in the South/Southeast (p = 0.095), in contrast to the Northeast (p = 0.047). This study highlights the potential intergenerational influence of maternal nutrition on HC, suggesting that maternal nutrition may be more relevant in families with major social vulnerability.

Fetal deaths in Brazil: What changed in the last decade and what can we learn from the current situation?

OBJECTIVE: To determine fetal death rates (FDRs) according to maternal characteristics in Brazil. METHODS: A serial cross-sectional analysis was conducted based on vital statistics of the Brazilian population from 2007 to 2019. FDRs were estimated according to maternal and pregnancy characteristics. Annual percent change (APC) of FDR was assessed by joinpoint regression model. Causes of death were compared between the ante-/intrapartum periods. RESULTS: A significant reduction in FDR occurred in Brazil during 2007-2019 (11.1 and 10.43 in 2007 and 2019, respectively; APC -0.44). Only the northern region showed an increase in FDR. In 2019, the northeast and southeast had the highest and lowest FDRs, respectively (11.4 and 7.8/1000 live births). In adolescents, FDR increased from 2007 to 2016 (APC 1.75). In 2019, missing information was significantly high for maternal skin color (99.7%), schooling (17.0%), and age (7.0%) in fetal death registries. The most common causes of fetal death in the ante-/intrapartum periods were fetus and newborn affected by maternal conditions. CONCLUSION: A reduction in FDR has been achieved in Brazil over the last decade. However, there is an unmet need for decreasing social and regional disparities. A better system to attribute causes of death is needed to identifying priorities in maternal-fetal health care.

Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial.

BACKGROUND: Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS: A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS: Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78-87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62-98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8-53% of low-risk women and median 5%, range 0-17% of high-risk women) were monitored for SGA as recommended. CONCLUSIONS: Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. TRIAL REGISTRATION: Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474 .

Proposal of MUAC as a fast tool to monitor pregnancy nutritional status: results from a cohort study in Brazil.

OBJECTIVE: In Brazil, although the assessment of maternal nutritional status is recommended using body mass index (BMI), this is only possible in settings adequately prepared. Midupper arm circumference (MUAC) is another biological variable identified as a tool for rapid assessment of nutritional status that is correlated with BMI. Therefore, we aim to surrogate BMI by MUAC cut-offs for rapid screening of maternal nutritional status starting at midpregnancy. DESIGN: Analysis of the multicentre cohort study entitled 'Preterm SAMBA' using an approach of validation of diagnostic test. SETTING: Outpatient prenatal care clinics from five tertiary maternity hospitals from three different Brazilian regions. PARTICIPANTS: 1165 pregnant women attending prenatal care services from 2015 to 2018 and with diverse ethnic characteristics who were enrolled at midpregnancy and followed in three visits at different gestational weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values, likelihood ratio and accuracy of MUAC being used instead of BMI for the assessment of nutritional status of women during pregnancy. RESULTS: We found a strong correlation between MUAC and BMI, in the three set points analysed (r=0.872, 0.870 and 0.831, respectively). Based on BMI categories of nutritional status, we estimated the best MUAC cut-off points, finding measures according to each category: underweight <25.75 cm (19-39 weeks); overweight 28.11-30.15 cm (19-21 weeks), 28.71-30.60 cm (27-29 weeks) and 29.46-30.25 cm (37-39 weeks); and obese >30.15 cm (19-21 weeks), >30.60 cm (27-29 weeks) and >30.25 cm (37-39 weeks) per gestational week. Therefore, we defined as adequate between 25.75-28.10 cm (19-21 weeks), 25.75-28.70 cm (27-29 weeks) and 25.75-29.45 cm (37-39 weeks) of MUAC. CONCLUSION: We conclude that MUAC can be useful as a surrogate for BMI as a faster screening of nutritional status in pregnant women.

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial-data management experience from the DESiGN Trial team.

BACKGROUND: The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study. METHODS: The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks. RESULTS: Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1-4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0-1) cluster at the second time point). Common data management challenges were harmonising a single variable from multiple sources and categorising free-text data, solutions were developed for this trial. CONCLUSIONS: Conduct of clinical trials which use electronic patient records for the assessment of outcomes can be time and cost-effective but still requires appropriate time and resources to maximise data quality. A difficulty for pregnancy and perinatal research in the UK is the wide variety of different systems used to collect patient data across maternity units. In this manuscript, we describe how we managed this and provide a detailed data dictionary covering the harmonisation of variable names and values that will be helpful for other researchers working with these data. TRIAL REGISTRATION: Primary registry and trial identifying number: ISRCTN 67698474 . Registered on 02/11/16.

The food patterns of a multicenter cohort of Brazilian nulliparous pregnant women.

Assessment of human nutrition is a complex process, in pregnant women identify dietary patterns through mean nutrient consumption can be an opportunity to better educate women on how to improve their overall health through better eating. This exploratory study aimed to identify a posteriori dietary patterns in a cohort of nulliparous pregnant women. The principal component analysis (PCA) technique was performed, with Varimax orthogonal rotation of data extracted from the 24-h dietary recall, applied at 20 weeks of gestation. We analysed 1.145 dietary recalls, identifying five main components that explained 81% of the dietary pattern of the sample. Dietary patterns found were: Obesogenic, represented by ultra-processed foods, processed foods, and food groups rich in carbohydrates, fats and sugars; Traditional, most influenced by natural, minimally processed foods, groups of animal proteins and beans; Intermediate was similar to the obesogenic, although there were lower loads; Vegetarian, which was the only good representation of fruits, vegetables and dairy products; and Protein, which best represented the groups of proteins (animal and vegetable). The obesogenic and intermediate patterns represented over 37% of the variation in food consumption highlighting the opportunity to improve maternal health especially for women at first mothering.