Purpose The PREgnancy Care Integrating Translational Science, Everywhere (PRECISE)-DYAD Study is a prospective observational cohort designed to investigate health outcomes among mother-child pairs (dyads) over the first 3 years of life in two contexts from sub-Saharan Africa. The primary objective of the study was to explore the effects of selected placenta-related complications, such as pregnancy hypertension, fetal growth restriction and preterm birth, on (1) Child health and development, and (2) Women’s health and well-being, including outcomes after stillbirth. Participants The PRECISE-DYAD Study enrolled women (and their children) originally recruited into the PRECISE pregnancy cohort study in The Gambia and Kenya between July 2021 and April 2024. Participants were seen at 6 weeks to 6 months, 12 months, 24 months and 36 months postpartum. Clinical and health data, including anthropometry and diet, were collected for both mothers and children. Mother assessment included a cardiology assessment and collection of data about symptoms of COVID-19 infection. In a subset of participants, mothers were asked about their mental health, their healthcare costs during and after pregnancy, and experiences of care during labour and childbirth/delivery. Additionally, a personal environmental exposure assessment was performed for a subset of the cohort by collecting air and water quality data alongside geographical, demographic and behavioural factors. Child development was assessed using neurodevelopmental assessments, home environment evaluation and quality of life measures. Biological samples were collected from mothers and children, processed promptly and biobanked locally. Sample data were entered into an OpenSpecimen database and linked to each individual, as well as to their corresponding social determinants and clinical data. Findings to date A total of 2980 women and 2909 children completed at least one PRECISE-DYAD Study visit. The biorepository contains 108 897 biological samples from mothers and children. Baseline descriptive analysis of the cohort is reported here. Future plans Analysis of data and samples will include biomarker studies, social determinants of health and epidemiological investigations. These analyses will explore how placenta-related complications and environmental exposures, such as nutrition and air quality, interact to shape maternal health, mental well-being, subsequent pregnancies and mother-child interaction, as well as child growth and neurodevelopment through early childhood. Additional work will examine the biological pathways linking these exposures to outcomes and the impacts of caring for children with moderate-to-severe disabilities on maternal well-being. Findings will be disseminated through scientific publications, conference presentations, engagement with local stakeholders and continued community outreach.

Background:Screening for, detecting, and managing pregnancy hypertension is a core function of antenatal care. To reduce both training requirements and the risks of measurement error in blood pressure (BP) values, automated and semiautomated BP devices have been validated in pregnant women with normal BP and pregnant women with hypertension and introduced for serial antenatal measurement of BP. objectives:The study aimed to (1) determine whether or not repeated BP measurements reduced the presence of terminal digit preference and (2) discern whether or not there was evidence of threshold avoidance in the Community-Level Interventions for Preeclampsia (CLIP) trials compared with the purely observational Pregnancy Care Integrating Translational Science, Everywhere (PRECISE) cohorts. Methods:The BP 3AS1-2 and CRADLE Vital Signs Alert low-cost Microlife BP devices were used by trained research staff in the CLIP trials conducted in India, Mozambique, Nigeria (pilot trial only), and Pakistan and the PRECISE cohorts of unselected pregnant women and nonpregnant women of reproductive age recruited in the Gambia, Kenya, and Mozambique. Both devices algorithmically calculate systolic blood pressure and diastolic blood pressure values displayed on digital read-outs. All BP readings were entered manually into a digital platform, which averaged them as the BP for that visit; the first and second readings were averaged unless they were more than 10 mm Hg different, which triggered a third reading, and the second and third readings were averaged. Results:A total of 51,875 participants had their BP measured 438,404 times. Using raw BP values, there was terminal digit preference (129,539/911,500, 14.21% vs 10%; P<.001 values ended in zero). A total of 28,929 out of 437,446 (6.61%) dBP values were 62 mm Hg, compared with 9310 of 195,349 (4.77%) from the averaged values (P<.001); errors were obviated by averaging BP values. There was evidence of both threshold preference and avoidance in the CLIP trials and the PRECISE cohort. Conclusions:Given the excess of 62 mm Hg values, there is a shared inherent algorithmic error in the calculation of dBP in the BP 3AS1-2 and CRADLE Vital Signs Alert devices. Averaged BP measurements are important to reduce the impact of user errors in manually recording BP values. We recommend that automated and semiautomated BP devices should be connected wirelessly to automatically transfer readings to digital health records to further optimize care.

Introduction: Food insecurity and undernutrition persist in much of sub-Saharan Africa. Women of reproductive age (WRA) who fail to meet the minimum dietary diversity (MDD-W) have inadequate nutrient intakes and increased risk of adverse pregnancy outcomes. This study assessed MDD-W in The Gambia, Kenya, and Mozambique and identified determinants. Methods: A food list-based 24-hour recall was conducted within the PRECISE Network, a prospective cohort study with pregnant and non-pregnant WRA in The Gambia, Kenya, and Mozambique. We descriptively summarized dietary diversity scores and rates of MDD-W (≥5 out of 10 food groups) and very low dietary diversity (≤2 food groups). We evaluated associated factors (demographic/household characteristics, socio-economic status, women’s autonomy), using multivariable regression models performed on R Studio (version 4.2.3). Results: Dietary intake data from 7,715 women (1,846 from The Gambia, 3,209 from Kenya, 2,660 from Mozambique) showed that 47.7% met MDD-W (65.1% The Gambia, 45.0% Kenya, 39.2% Mozambique). Pregnant women had a slightly higher rate of meeting MDD-W compared with non-pregnant WRA (48.4% pregnant vs 45.6% non-pregnant [aOR 1.65, 95% CI: 1.40, 1.95]). Higher educational attainment, professional and small business occupations, pregnancy status, parity, household size, marital status and being from The Gambia were protective factors for meeting MDD-W. Poverty and living alone were risk factors for unmet MDD-W. Poverty and country of residence (Mozambique), were risk factors for very low dietary diversity. Conclusion: A majority of the PRECISE cohort did not meet MDD-W, including both pregnant and non-pregnant WRA, suggesting inadequate micronutrient status before pregnancy and limited dietary diversity improvement during pregnancy. Socio-economic indicators are key determinants of adequate dietary diversity, but local contextualisation is essential. Our study highlights the importance of nutrition-specific and -sensitive interventions in women and girls across the lifespan.

Background:Stillbirth is a critical public health challenge in sub-Saharan Africa, but prospective data on incidence and risk factors remain limited. We conducted a multi-country study in Kenya, Mozambique, and The Gambia to determine stillbirth rates and underlying risk factors. Methods:We analysed pooled data from 5772 women aged 16-49 with birth outcomes enrolled from seven health facilities in Mozambique, Kenya, and The Gambia participating in the PRECISE (PREgnancy Care Integrating translational Science, Everywhere) cohort (2019-2022). We used bivariable and multivariable modified Poisson regression models to assess associations between maternal socio-demographic, environmental, medical, including obstetric, and health system factors with stillbirth (≥20 weeks gestation or weighing ≥500 g). Findings:Overall stillbirth incidence was 29.2 per 1000 total births (95%CI 24.8-33.6): 17.5 (95% CI:12.5-22.5) in Kenya, 32.8 (95% CI:24.7-40.9) in Mozambique, and 49.8 (95%CI: 37.4-62.4) in The Gambia. The majority (89.1%) occurred at ≥28 weeks gestation. Significant risk factors were a history of previous stillbirth (attributable risk ratio (aRR) = 3.18, 95% CI: 1.85-5.46), Stage 2 hypertension (aRR = 3.25, 95% CI: 1.42-7.44), antepartum haemorrhage (aRR = 3.10, 95% CI: 1.77-5.42), Caesarean delivery aRR = 1.74 (95%CI:1.01-3.01), and small-for-gestational age (aRR = 2.05 (95%CI:1.34-3.12)). Interpretation:Stillbirth rates remain unacceptably high across these settings, with country variations. Multifactorial determinants underscore the need for integrated antenatal and intrapartum care strategies addressing systemic barriers to early detection of risk, robust referral systems and timely access to high-quality emergency obstetric care towards ending preventable stillbirths in these contexts. Funding:The PRECISE Network was funded by the UK Research and Innovation Grand Challenges Research Fund GROW Award scheme (grant number: MR/P027938/1). The PRECISE cohort extension in Kenya after January 2022 was funded by the Office of the Director, National Institutes of Health, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Mental Health, and the Fogarty International Center AT THE NATIONAL INSTITUTES OF HEALTH under award number U54TW012089. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Air pollution is a major contributor to mortality and adverse health outcomes, particularly in pregnant women and children, with vehicular emissions as a key source. This study aimed to characterize long-term exposure to fine particulate matter (PM2.5), evaluate potential health risks, and quantify the contribution of road transport and proximity to roads in The Gambia, Kenya, and Mozambique. Multi-temporal personal exposure data were interpolated into continuous spatial surfaces and aggregated into daily averages, which were then compared with World Health Organization (WHO) guidelines to assess potential health impacts. Multi-distance buffers at 10 m intervals up to 1000m from major roads were created to examine pollutant variation with road proximity. Overlay analyses and linear regression models were applied to quantify the road-edge effect on pollution exposure. The Inverse Distance Weighting interpolation technique produced accurate PM2.5 field in all sites (R2>0.55, MAE<4 μg/m3 and RMSE<10 μg/m3) based on leave-one-out cross-validation. PM2.5 concentrations were highest in The Gambia across all land use and land cover (LULC) types, reflecting localized industrial and vehicular emissions. Elevated pollutant levels were observed in herbaceous wetlands, bare land, and built-up areas. Most sites across all three countries exceeded WHO recommended thresholds, indicating significant health risks. PM2.5 decreased with distance from roads in Rabai (Kenya) and Mozambique, while in other sites it increased away from roads. These findings highlight the combined influence of multiple local sources, including traffic, fire smoke, wetlands, and industry, on pollutant exposure. The study demonstrates the utility of WHO thresholds for health risk assessment and shows how road proximity affects pollutant dispersal. The results provide critical insights for modeling air pollution exposure and informing mitigation strategies in sub-Saharan Africa.

Background Most tuberculosis (TB) cases in The Gambia are notified in the Greater Banjul Area (GBA). We conducted an Enhanced-Case-Finding (ECF) intervention in the GBA and determined its effect on TB case notifications and ongoing TB transmission. Methods This was a cluster randomized trial in which randomly assigned intervention areas of grouped settlements received three rounds of an ECF strategy consisting of sensitization followed by auramine microscopy, whereas people with TB in control areas continued to be identified through passive case finding. People with TB were recruited at the TB diagnostic and treatment centers serving both the intervention- and control areas. The primary outcome was TB case notification rate. To exclude that an increase in notified cases, followed by a decrease in notified cases, would hide the future impact of the intervention, we tested for changes in transmission dynamics using both genetic clustering and phylodynamic methods. Results 3,047 people living with TB were recruited in the study, evenly split between intervention and control regions. No significant difference in TB case notification rates, transmission clustering or effective reproductive number was detected between intervention and control areas using either a case notification rate or phylodynamic approach. Conclusion Although we did not find evidence for decreased TB case notification nor TB transmission through the ECF strategy used, this approach is an examplar of how both classical epidemiology and genomic phylodynamics approaches can be integrated to better assess public health intervention outcomes.

Background : Heat exposure during pregnancy has been linked to adverse maternal health outcomes. However, evidence regarding the relationship between ambient heat and hypertensive disorders of pregnancy (HDP) mixed with limited evidence from low- and middle-income countries (LMICs) in sub-Saharan Africa. Methods: We examined the association between ambient heat exposure and HDP among women in the PRECISE pregnancy cohort (The Gambia, Kenya and Mozambique). Logistic regression models estimated associations between pregnancy window and preconception pregnancy windows and risk of HDP. Results and Discussion: The cohort analysis subset HDP incidence was 15.9%. HDP status varies by maternal age, education, and other characteristics. Each 1°C increase in first-trimester temperature was associated with 8% increased odds of HDP (aOR 1.08, 95%CI:1.04 to 1.13, p<0.001). A similar relationship was observed for preconception heat exposure. Conclusion: First trimester heat exposure was associated with increased HDP risk, highlighting early pregnancy as a critical window for targeted interventions.

Intrapartum-related asphyxia (IRA) is a major cause of neonatal mortality and long-term neurodevelopmental impairment, yet little is known about the role of environmental stressors. Using clinical cohort data from 13,803 births in The Gambia and Burkina Faso linked to ERA5 temperature data, we applied a time-stratified case-crossover design to investigate the short-term effects of heat exposure on IRA. Exposure to extreme daytime heat in the days preceding delivery was associated with increased odds of IRA, with stronger associations observed at higher temperature thresholds and longer exposure durations. Among live births, the most extreme multi-day heat events nearly doubled the odds of IRA. No associations were observed for minimum temperatures. These findings suggest that extreme heat may act as an acute trigger of intrapartum complications and highlight the need to strengthen maternal and newborn health systems in regions facing increasing heat exposure.

Background Most tuberculosis (TB) cases in The Gambia are notified in the Greater Banjul Area (GBA). We conducted an Enhanced-Case-Finding (ECF) intervention in the GBA and determined its effect on TB case notifications and ongoing TB transmission. Methods This was a cluster randomized trial in which randomly assigned intervention areas of grouped settlements received three rounds of an ECF strategy consisting of sensitization followed by auramine microscopy, whereas people with TB in control areas continued to be identified through passive case finding. People with TB were recruited at the TB diagnostic and treatment centers serving both the intervention- and control areas. The primary outcome was TB case notification rate. To exclude that an increase in notified cases, followed by a decrease in notified cases, would hide the future impact of the intervention, we tested for changes in transmission dynamics using both genetic clustering and phylodynamic methods. Results 3,047 people living with TB were recruited in the study, evenly split between intervention and control regions. No significant difference in TB case notification rates, transmission clustering or effective reproductive number was detected between intervention and control areas using either a case notification rate or phylodynamic approach. Conclusion Although we did not find evidence for decreased TB case notification nor TB transmission through the ECF strategy used, this approach is an examplar of how both classical epidemiology and genomic phylodynamics approaches can be integrated to better assess public health intervention outcomes.

The World Health Organization recommends a minimum of eight antenatal care (ANC) contacts, with the first visit occurring before the 12 th week of gestation, as a strategy to enhance the preparedness of women for institutional delivery and improve perinatal outcomes. The present study aims to assess the prevalence of delayed ANC attendance among pregnant women in rural Burkina Faso and identify associated risk factors. This is a secondary analysis of clinical data collected from a randomised-controlled trial ( clinicaltrials.gov ref: NCT03199547 ); conducted between 2018 and 2021 in rural Burkina Faso. We estimated gestational age (GA) at the first ANC visit based on recall information on the last menstrual period provided by study participants or, when such information was unavailable, symphysis-fundal height measurements taken by ANC nurses. We used descriptive methods followed by unadjusted and adjusted logistic regression, informed by an original conceptual framework, to determine the prevalence and risk factors associated with delayed first ANC visit, defined as occurring after the 12 th week of gestation. A significance threshold was set at 0.05. Out of the 5250 women enrolled in the study, 2480 (47.2%) had data available from their first ANC visit, and 90.6% (2248/2480) of those women had gestational age estimates. Most women (n=2037/2248, 90.6%) attended their first ANC after the 14 th week of gestation. The main factors associated with this delay were multiparity ≥ 4 pregnancies (OR=2.26, 95%CI [1.48 – 3.4], p < 0.001) and first ANC visit attended during the dry season (OR=1.79, 95%CI [1.34 – 2.39], p < 0.001). Our study highlights that most pregnant women in rural Burkina Faso attended their first ANC visit later than the WHO recommended timeline, increasing their risk of poor delivery outcome. Although we identified some factors that increased this risk of late ANC attendance, awareness raising interventions are required for the whole population as starting late seems to be the norm.

Purpose The PREgnancy Care Integrating translational Science, Everywhere Network was established to investigate specific placental disorders (pregnancy hypertension, preterm birth, fetal growth restriction and stillbirth) in sub-Saharan Africa. We created a repository of clinical and social data with associated biological samples from pregnant and non-pregnant women. Alongside this, local infrastructure and expertise in the field of maternal and child health research were enhanced.Participants Pregnant women were recruited in participating health facilities in The Gambia, Kenya and Mozambique at their first antenatal visit or at the time a placental disorder was diagnosed (Kenya and The Gambia only). Follow-up study visits were conducted in the third trimester, delivery and 6 weeks to 6 months postpartum. To elucidate the difference between pregnancy and non-pregnancy biology in these settings, non-pregnant nulliparous and parous women, aged 16–49 years, were recruited opportunistically primarily from family planning clinics in Kenya and Mozambique, and randomly through the Health and Demographic Surveillance System in The Gambia. Non-pregnant participants only had one study visit. Biological samples were processed rapidly and locally, stored initially in liquid nitrogen and then at −80°C, and details entered into an OpenSpecimen database linked to their social determinants and clinical research data.Findings to date A total of 6932 pregnant and 1825 non-pregnant women were recruited to the study, providing a repository of clinical and social data and a biorepository of 482 448 samples. To date, baseline descriptive analysis of the cohort has been undertaken, as well as a substudy on the prevalence of COVID-19 in the cohort.Future plans Analysis of data and samples will include an analysis of biomarker and social and physical determinants of health and how these interact in a systemic approach to understanding the origins of common placental disorders. The data from non-pregnant women will provide control data for comparison with the data from normal and complicated pregnancies. Findings will be disseminated to local stakeholders and communities through meetings and ongoing community engagement and globally by publication and presentations at scientific meetings.

Purpose:The PRECISE-DYAD study is a prospective observational cohort, designed to investigate health outcomes among mother-child pairs (dyads), over the first three years of life in two contexts from sub-Saharan Africa. The primary objective of the study was to explore the effects of selected placenta-related complications, such as pregnancy hypertension, fetal growth restriction, and preterm birth, on 1) child health and development, and 2) women's health and well-being, including outcomes after stillbirth. Participants:The PRECISE-DYAD study enrolled women (and their children) originally recruited into the PRECISE regnancy cohort study in The Gambia and Kenya between July 2021 and April 2024. Participants were seen at 6 weeks to 6 months, 12 months, 24 months, and 36 months post-partum. Clinical and health data, including anthropometry and diet were collected for both mothers and children. Mother assessment included a cardiology assessment and collection of data about symptoms of COVID-19 infection. In a subset of participants, mothers were asked about their mental health, their health care costs during and after pregnancy, and experiences of care during labour and childbirth / delivery. Additonally, a personal environmental exposure assessement was performed for a subset of the cohort, by collecting air and water quality data alongside geographical, demographic, and behavioural factors. Child development was assessed using neurodevelopmental assessments, home environment evaluation, and quality of life measures. Biological samples were collected from mothers and children, processed promptly and biobanked locally. Sample data were entered into an OpenSpecimen database and linked to each individual, as well as to their corresponding social determinants and clinical data. Findings to date:A total of 2,980 women and 2,909 children completed at least one PRECISE-DYAD study visit. The biorepository contains 108,897 biological samples from mothers and children. Baseline descriptive analysis of the cohort are reported here. Future plans:Analysis of data and samples will include biomarker studies, social determinants of health, and epidemiological investigations. These analyses will explore how placenta-related complications and environmental exposures, such as nutrition and air quality, interact to shape maternal health, mental well-being, subsequent pregnancies, and mother-child interaction, as well as child growth and neurodevelopment through early childhood. Additional work will examine the biological pathways linking these exposures to outcomes and the impacts of caring for children with moderate-to-severe disabilities on maternal well-being. Findings will be disseminated through scientific publications, conference presentations, engagement with local stakeholders, and continued community outreach.

Introduction: Approximately 20 million neonates are born with low birth weight (LBW) annually, with West Africa bearing the highest burden of LBW and associated poor outcomes. This study aims to estimate the prevalence of LBW, identify maternal and foetal risk factors, and describe associated adverse perinatal and neonatal outcomes in a West African cohort. Methods: These are secondary analyses of data from a randomised clinical trial (PregnAnZI-2). Pregnant women without known acute or chronic conditions were enrolled during labour at ten primary and secondary health facilities in The Gambia and Burkina Faso (2017-2021). Birth weight was measured within 24h of birth using standardised methods. Logistic regression was applied to identify associations between LBW and both selected risk factors and adverse outcomes, guided by a novel conceptual framework. Results: 11,980 women and their 12,027 offspring were included in this study. The overall prevalence of LBW was 9.6% (1159/12027): 8.2% (551/6681) in The Gambia and 11.4% (608/5346) in Burkina Faso. Maternal risk factors for LBW included maternal ethnicity (p<0.001), primiparity (aOR 1.63, 9% CI 1.33-1.99, p<0.001), and previous history of stillbirth (aOR 1.88, 95% CI 1.35-2.62, p<0.001), while foetal risk factors included female sex (aOR 1.58, 95% CI 1.38-1.80, p<0.001) and twin birth (aOR 22.96, 95% CI 18.51-28.48, p<0.001). LBW newborns had increased risk of neonatal mortality (cOR 4.35, 95% CI 3.25-5.81, p<0.001); intrapartum stillbirth (cOR 3.37, 95% CI 2.07-5.51, p<0.001); neonatal hospitalisation (cOR 2.17, 95% CI 1.70-2.77, p<0.001); and intrapartum-related asphyxia defined as 1-min Apgar score <7 (cOR 2.04, 95% CI 1.59-2.62, p<0.001). 30.7% (69/225) of neonatal deaths and 26.2% (22/84) of intrapartum stillbirths were attributable to LBW. Conclusion: This study underlines the substantial contribution of LBW towards adverse perinatal and neonatal outcomes in West Africa. Early identification of in-utero growth restriction and women at risk of preterm delivery could enable targeted antenatal interventions and timely referral for hospital delivery, improving perinatal and neonatal outcomes to reach Sustainable Development Goal 3.2. ### Competing Interest Statement Dr. Usman N. Nakakana reported being an employee of the Bill and Melinda Gates Foundation in Seattle, United States, and owning shares of the company. No other disclosures were reported. ### Funding Statement The PregnAnZI-2 trial was funded by a grant from the UKRI under the Joint Global Health Trial Scheme (JGHT)(ref: MC\_EX\_MR/P006949/1) and the Gates Foundation (Ref: OPP1196513). The publication of this supplement was funded by the Gates Foundation as a whole. The funders and study sponsor (MRCG at LSHTM) had no role in the study design, collection, analysis, or interpretation of data, writing of the article, or the decision to submit for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The PregnAnZI-2 trial was approved by The Gambia Government/Medical Research Council Unit, The Gambia (MRCG) Joint Ethics Committee, the Comite dEthique pour la Recherche en Sante (CERS) and the Ministry of Health of Burkina Faso, and the LSHTM Ethics Committee. This included approval for further research utilising trial data. All women provided written informed consent for trial participation during antenatal care visits and were free to withdraw at any time. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data may be obtained from a third party and is not publicly available. The clinical data have been collected following the provision of informed consent, under the prerequisite of strict participant confidentiality. Qualified researchers may request access through the Gambia Government/MRC Joint Ethics Committee. The review process and release of data will be facilitated by the MRC Unit The Gambia (http://www.mrc.gm/) through the Head of Governance at MRCG at LSHTM. Access will not be unduly restricted.

The prevalence of congenital malformations remains high and significantly contributes to neonatal morbidity and mortality in West Africa. However, there is a gap in the existing literature regarding the clinical epidemiology of congenital malformations in the African subregion. This study aimed to describe the clinical presentation, prevalence, risk factors, and adverse neonatal outcomes of newborns with easily recognisable congenital malformations in urban Gambia. This descriptive cohort study consisted of secondary analyses of a clinical trial data (PregnAnZi2 trial) for liveborn neonates delivered between October 2017 to May 2021 at two public health facilities in The Gambia. Congenital malformations were detected by clinical examination at birth with active and passive surveillance for 28 days after delivery. Congenital malformations were classified according to ICD11 definitions, with sub-classification into major or minor malformations as per WHO guidance. 140 out of 6750 neonates (2.1%) had at least one congenital malformation, with 29.3% (44/150) of these malformations classified as major. The musculoskeletal system was most frequently affected (58%, 87/150) with talipes equinovarus as the most common major malformation identified (43%, 19/44). A history of previous miscarriage was associated with an increased risk of congenital malformations (aOR 1.72, 95% CI 1.02 to 2.73, p value=0.04). Newborns with a congenital malformation were more likely to experience adverse neonatal outcomes than newborns without, with higher odds of low 1 minute Apgar score, (cOR 3.09, 95% CI 1.62 to 5.48, p <0.001), low 5 min Apgar score (cOR 6.10, 95% CI 2.10 to 14.62, p <0.001), hospitalisation during the neonatal period (cOR 4.42, 95% CI 2.77 to 6.83, p <0.001) and mortality within 24hrs of delivery (cOR 48.75, 95% CI 11.08 to 215.62, p <0.001). Among 70 neonatal deaths recorded by day 28 after birth, 15 (21.4%) were newborns with congenital malformation. The circulatory and skeletal systems were equally affected among congenital malformations recorded in neonatal deaths by day 28 (23.8%, 5/21). Despite a relatively low prevalence, easily recognisable congenital malformations are associated with substantial neonatal morbidity and mortality. Improved antenatal diagnosis of congenital malformations is urgently required to optimise delivery strategies and improve perinatal outcomes, especially for women experiencing previous miscarriage. NCT03199547: Clinicaltrials.gov. Registered on 23rd June 2017

Pregnant and lactating women in sub-Saharan Africa are vulnerable to micronutrient inadequacies, with risk of adverse pregnancy outcomes. Adequate intakes of diverse foods are associated with better micronutrient status and recommended by the World Health Organization as part of healthy eating counselling during antenatal care. However, our understanding of community knowledge of dietary diversity within the context of maternal diets is limited. We used a descriptive qualitative approach to explore community perceptions of dietary diversity during pregnancy and lactation, as well as influencing factors in sub-Saharan Africa. A total of 47 in-depth interviews were conducted between May and October 2022 in Kenya, Mozambique and The Gambia with a purposively drawn sample of pregnant women and mothers who had delivered within two years preceding the data collection, their male and female relatives, and community opinion leaders. Other methods included participant observation and photovoice. Data were analyzed using a thematic approach on NVivo software. Dietary diversity was found to be well aligned with local perceptions of healthy meals. All participants were able to differentiate between starchy staple grains and additional foods to provide nutrients. While diverse meals were valued for pregnant and lactating mothers, participants across the three countries shared that maternal diets were not more diverse compared to typical household meals. Furthermore, diverse diets were inaccessible for many in their communities, due to challenges in affordability, seasonality, gender norms, knowledge and preferences. Adequate nutrition knowledge, accessibility of foods, and support of household decision-makers, particularly husbands and partners, were all identified as critical to ensure women have adequate diverse maternal diets.

BACKGROUND:Testing is a critical component to control disease outbreaks. The screening process required to enrol study participants from individuals with suspected COVID-19 disease in a clinical trial, presented an opportunity to explore factors that influence the willingness to be tested for COVID-19. METHODS:We analyzed data from individuals with symptoms suggestive of mild-moderate COVID-19 in two different health facilities in Western Gambia. As part of pre-enrollment screening for recruitment into a COVID-19 drug trial, we recorded clinical, epidemiological, and demographic information. Individuals who consented had a nasopharyngeal and/or oropharyngeal sample collected for SARS-CoV-2 testing. We compared consenting and non-consenting individuals using univariate and multivariable logistic regression and calculated adjusted odds ratio. Over-time trends were visualised using a 30-day moving sum for participants who consented. RESULTS:Among the 1361 suspected COVID-19 individuals identified between January 2021 and August 2022, 33.4 % (458/1361) consented to be tested for SARS-CoV-2. In the multivariate analysis, history of smoking (aOR: 3.07, 95 %CI: 1.60-5.88 p < 0.001), high educational level (aOR: 6.32, 95 %CI: 3.84-10.39 p < 0.001), history of travel (aOR: 2.94, 95 %CI: 1.20-7.22, p = 0.019), and loss of smell (aOR: 4.00, 95 %CI: 2.24-7.17 p = 0.002,) were significantly associated with acceptance to COVID-19 testing. The 30-day moving sum showed a downward trend of testing acceptance over time. CONCLUSION:Although testing acceptance was very low, individuals with recognised risk factors for COVID-19 were more likely to accept testing. Early and sustained information about these risk factors particularly targeting individuals in low-education cadres may enhance testing uptake during a pandemic.

Neonatal sepsis is a major contributor to adverse neonatal outcomes in West Africa. High quality data on risk factors for sepsis in this region is limited, yet important for surveillance, prevention and management of newborns at greatest risk. This study aimed to describe the clinical epidemiology of sepsis for health-facility born neonates in an urban West African setting. This study comprised secondary data analyses from the Gambian cohort of the PregnAnZI-2 randomised clinical trial. Relatively healthy pregnant women and their offspring who delivered at two urban health facilities were included, with a combination of active and passive surveillance until 28 days. Neonatal sepsis was defined as suspected if clinical and laboratory (abnormal FBC or CRP) criteria were met, and confirmed if blood-culture was positive. A novel conceptual framework informed logistic regression models to identify 1) factors associated with neonatal sepsis and 2) contribution of sepsis towards neonatal mortality. A total of 6515 neonates were included. The health-facility based incidence of neonatal sepsis was 20.2 cases/1000 live births (N=131 cases), predominantly early-onset (<3 days)(15.7 cases/1000 livebirths). Confirmed sepsis accounted for 22% (29/131) of all cases, with Burkholderia cepacia and Staphylococcus aureus the most prevalent bacteria in 24% (7/29) of confirmed sepsis each. Risk factors for sepsis included low 1-minute Apgar score (aOR 13.2, 95% CI 8.40-20.73), pre-labour maternal fever (aOR 5.0, 95% CI 1.15-21.69), easily recognisable congenital malformation (aOR 3.39, 95% CI 1.55-7.38) and low-birth weight (aOR 2.85, 95% CI 1.75-4.65). 40.7% of all neonatal deaths in the cohort occurred in neonates with sepsis, with 40-fold increase in mortality compared to neonates without sepsis (OR: 39.98, 95% CI 22.5 – 71.1). Sepsis, especially early onset, is a major morbidity for health facility born neonates delivered following relatively healthy pregnancy in urban Gambia, with high associated mortality. We identify neonatal phenotypes (low birth weight, newborns with low 1-minute apgar scores, or those with easily recognisable congenital malformations) who may benefit from enhanced postnatal surveillance or antibiotics to prevent or treat neonatal sepsis and reduce neonatal mortality. NCT03199547: Clinicaltrials.gov . Registered on 23 rd June 2017

Intrapartum azithromycin prophylaxis reduced maternal infections but showed no effect on neonatal sepsis and mortality. Although antibiotic exposure may indirectly alter the mycobiota (community of fungi that live in a given environment), there is no data available on how intrapartum azithromycin impacts gut mycobiota development. We hereby assess the impact of intrapartum azithromycin on gut mycobiota development from birth to the age of three years, by ITS2 gene profiling of rectal samples from 102 healthy Gambian infants selected from a double-blind randomized placebo-controlled clinical trial (PregnAnZI-2 – ClinicalTrials.org NCT03199547). In the trial, women received 2 g oral azithromycin or placebo (1:1) during labour with the intension of assessing effect on neonatal sepsis or mortality. Secondary objectives included effects on bacterial carriage and resistance, puerperal infections, and infant growth. Our analysis show that season and parity were key factors that influenced gut mycobiota development. Intrapartum azithromycin increased the abundance of Candida orthopsilosis but only in the wet season and did not show different effects by sex of the child. These data suggest that season and parity can be key factors influencing gut mycobiota development and may inform strategies for a wider implementation of intrapartum azithromycin intervention.