Correction: Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pmed.1004186.].

Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

BACKGROUND: Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy-protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. METHODS AND FINDINGS: A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (-3.18 percentage points (pp), 95% CI [-5.86 to -0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (-2.74 pp, 95% CI [-5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. CONCLUSIONS: This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03533712.

Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso.

BACKGROUND: Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using energy-dense supplements is that they could lead to more maternal and/or infant overweight. However, evidence is lacking on the potential effect of BEP on maternal and offspring body composition. This study evaluates the effects of micronutrient-fortified BEP supplementation during pregnancy on body composition of mothers and their newborns in rural Burkina Faso. METHODS AND FINDINGS: The MISAME-III study is an open label individually randomized controlled trial where pregnant women (n = 1,897) of gestational age <21 weeks received either a combination of micronutrient-fortified BEP and iron-folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control). The prenatal phase of the MISAME-III study was conducted between the first enrollment in October 2019 and the last delivery in August 2021. In a sub-study nested under the MISAME-III trial, we evaluated anthropometry and body composition in newborns who were born starting from 17 November 2020 (n: control = 368 and intervention = 352) and their mothers (n: control = 185 and intervention = 186). Primary study outcomes were newborn and maternal fat-free mass (FFMI) and fat-mass (FMI) indices. We used the deuterium dilution method to determine FFMI and FMI and %FFM and %FM of total body weight within 1 month postpartum. Our main analysis followed a modified intention-to-treat approach by analyzing all subjects with body composition data available. Univariable and multivariable linear regression models were fitted to compare the intervention and control arms, with adjusted models included baseline maternal age, height, arm fat index, hemoglobin concentration and primiparity, household size, wealth and food security indices, and newborn age (days). At study enrollment, the mean ± SD maternal age was 24.8 ± 6.13 years and body mass index (BMI) was 22.1 ± 3.02 kg/m2 with 7.05% of the mothers were underweight and 11.5% were overweight. Prenatal micronutrient-fortified BEP supplementation resulted in a significantly higher FFMI in mothers (MD (mean difference): 0.45; 95% CI (confidence interval): 0.05, 0.84; P = 0.026) and newborns (MD: 0.28; 95% CI: 0.06, 0.50; P = 0.012), whereas no statistically significant effects were found on FMI. The effect of micronutrient-fortified BEP on maternal FFMI was greater among mothers from food secure households and among those with a better nutritional status (BMI ≥21.0 kg/m2 or mid-upper arm circumference (MUAC) ≥23 cm). Key limitations of the study are the relatively high degree of missing data (approximately 18%), the lack of baseline maternal body composition values, and the lack of follow-up body composition measurements to evaluate any long-term effects. CONCLUSIONS: Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI. TRIAL REGISTRATION: ClinicalTrials.gov with identifier NCT03533712.

Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial.

BACKGROUND: Providing balanced energy-protein (BEP) supplements is a promising intervention to improve birth outcomes in low- and middle-income countries (LMICs); however, evidence is limited. We aimed to assess the efficacy of fortified BEP supplementation during pregnancy to improve birth outcomes, as compared to iron-folic acid (IFA) tablets, the standard of care. METHODS AND FINDINGS: We conducted an individually randomized controlled efficacy trial (MIcronutriments pour la SAnté de la Mère et de l'Enfant [MISAME]-III) in 6 health center catchment areas in rural Burkina Faso. Pregnant women, aged 15 to 40 years with gestational age (GA) <21 completed weeks, were randomly assigned to receive either fortified BEP supplements and IFA (intervention) or IFA (control). Supplements were provided during home visits, and intake was supervised on a daily basis by trained village-based project workers. The primary outcome was prevalence of small-for-gestational age (SGA) and secondary outcomes included large-for-gestational age (LGA), low birth weight (LBW), preterm birth (PTB), gestational duration, birth weight, birth length, Rohrer's ponderal index, head circumference, thoracic circumference, arm circumference, fetal loss, and stillbirth. Statistical analyses followed the intention-to-treat (ITT) principle. From October 2019 to December 2020, 1,897 pregnant women were randomized (960 control and 937 intervention). The last child was born in August 2021, and birth anthropometry was analyzed from 1,708 pregnancies (872 control and 836 intervention). A total of 22 women were lost to follow-up in the control group and 27 women in the intervention group. BEP supplementation led to a mean 3.1 percentage points (pp) reduction in SGA with a 95% confidence interval (CI) of -7.39 to 1.16 (P = 0.151), indicating a wide range of plausible true treatment efficacy. Adjusting for prognostic factors of SGA, and conducting complete cases (1,659/1,708, 97%) and per-protocol analysis among women with an observed BEP adherence ≥75% (1,481/1,708, 87%), did not change the results. The intervention significantly improved the duration of gestation (+0.20 weeks, 95% CI 0.05 to 0.36, P = 0.010), birth weight (50.1 g, 8.11 to 92.0, P = 0.019), birth length (0.20 cm, 0.01 to 0.40, P = 0.044), thoracic circumference (0.20 cm, 0.04 to 0.37, P = 0.016), arm circumference (0.86 mm, 0.11 to 1.62, P = 0.025), and decreased LBW prevalence (-3.95 pp, -6.83 to -1.06, P = 0.007) as secondary outcomes measures. No differences in serious adverse events [SAEs; fetal loss (21 control and 26 intervention) and stillbirth (16 control and 17 intervention)] between the study groups were found. Key limitations are the nonblinded administration of supplements and the lack of information on other prognostic factors (e.g., infection, inflammation, stress, and physical activity) to determine to which extent these might have influenced the effect on nutrient availability and birth outcomes. CONCLUSIONS: The MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. However, the intervention had a small positive effect on other birth outcomes. Additional maternal and biochemical outcomes need to be investigated to provide further evidence on the overall clinical relevance of BEP supplementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03533712.

Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso.

BACKGROUND: Panel data indicate that nonpregnant women's dietary diversity fluctuates across climatic seasons in low- and middle-income countries. The natural day-to-day variability in food group consumption during gestation is unknown. OBJECTIVES: A longitudinal study was conducted among pregnant women enrolled in the Micronutriments pour la Santé de la Mère et de l'Enfant study 3 randomized controlled efficacy trial [i.e., daily fortified balanced energy-protein supplement and an iron-folic acid (IFA) tablet compared with an IFA tablet only] to investigate the number of 24-hour recalls required to estimate usual prenatal food group (FG) diversity and the seasonality of pregnant women's dietary diversity in Houndé, Burkina Faso. METHODS: FG consumption was assessed twice weekly by qualitative, list-based, 24-hour recalls among 1757 pregnant women (892 control, 865 intervention). The number of days needed to estimate a woman's usual prenatal 10-point FG diversity score was calculated using the within-subject coefficient of variation. Regression models, including truncated Fourier series, were fitted to assess seasonal variations in the FG diversity score and the probability of reaching Minimum Dietary Diversity for Women (MDD-W; i.e., ≥5 FGs). RESULTS: The monthly mean FG scores (<5 FGs) and MDD-W prevalence (<45%) were low. Five list-based recalls allowed observed FG diversity to lie within 15% of the true mean in 90% of the estimations (mean ± SD, 40.4 ± 20.7 recalls per woman). Both the FG diversity score and prevalence achieving MDD-W showed responsiveness to seasonal variations, with peaks at the end of the dry season (i.e., April or May) and troughs in the rainy season (i.e., August). CONCLUSIONS: Five list-based recalls are sufficient to estimate usual FG diversity during gestation, although intra-annual seasonal patterns did modestly affect the FG diversity score and MDD-W prevalence. Thus, timing of repeated dietary surveys is critical to ensure nonbiased inferences of change and trends in Burkina Faso. This trial was registered at clinicaltrials.gov as NCT03533712.

Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.

BACKGROUND: Anemia and suboptimal gestational weight gain (GWG) are associated with adverse maternal and birth outcomes. Limited research indicates that balanced energy-protein (BEP) supplements reduce the incidence of inadequate GWG. OBJECTIVES: We assessed the efficacy of a micronutrient-fortified BEP supplement on the secondary outcomes of anemia, GWG, GWG rate, and GWG in relation to the Institute of Medicine (IOM)'s recommendations, as compared with an iron-folic acid (IFA) tablet. METHODS: We conducted a randomized controlled trial in Burkina Faso, among pregnant women (15-40 y old) enrolled at <21 weeks of gestation. Women received either BEP and IFA (intervention) or IFA (control). Hemoglobin (g/dL) concentrations were measured at baseline and the third antenatal care visit (ANC), whereas maternal weight was measured at baseline and all subsequent ∼7-weekly ANCs. GWG (kg) was calculated as a woman's last weight measurement (at ∼36 weeks of gestation) minus weight at enrollment, whereas GWG rate (kg/wk) was GWG divided by the time between the first and last weight measurements. GWG adequacy (%) was computed as GWG divided by the IOM's recommendation. Binary outcomes included severely inadequate, inadequate, and excessive GWG. Statistical analyses followed the intention-to-treat principle. Linear regression and probability models were fitted for the continuous and binary outcomes, respectively, adjusting for baseline measurements. RESULTS: Women in the BEP group tended to have higher, but nonsignificantly different, GWG (0.28 kg; 95% CI: -0.05, 0.58 kg; P = 0.099). Furthermore, there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or incidence of inadequate or excessive GWG. Findings were robust to model adjustments and complete case and per protocol analyses. CONCLUSIONS: This trial does not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG, as compared with IFA. In conjunction with the small, but positive, effects of maternal BEP supplementation on birth outcomes, our findings warrant the investigation of additional biochemical and postnatal outcomes.This trial was registered at clinicaltrials.gov as NCT03533712.

Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso.

BACKGROUND: In many low- and middle-income countries, the prevalence of energy and nutrient deficiencies is high among pregnant women. Balanced energy-protein (BEP) supplements are a promising strategy to cover nutritional requirements during pregnancy and improve birth outcomes. However, the displacement of nutrient-dense foods by BEP might attenuate the efficacy of supplementation. OBJECTIVE: This cross-sectional study of participants in a randomized controlled trial evaluated the difference in energy and macro- and micronutrient intakes, food groups, and nutrient adequacy between a control and intervention group receiving either a daily iron-folic acid (IFA) tablet or IFA and BEP supplement during pregnancy, respectively. METHODS: We collected a single multiple-pass 24-h recall from 470 pregnant women from the MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III study that investigates the efficacy of BEP supplementation on birth outcomes and infant growth. Dietary intake (median and IQR) and nutrient adequacy were assessed using individual recipes and preparation methods of mixed dishes for each participant. Linear regression models were fitted to compare energy and nutrient intakes. RESULTS: Dietary energy, and macro- and micronutrient intakes were significantly higher among women in the intervention group when including BEP [2329 kcal/d (1855, 3008 kcal/d) compared with 1942 kcal/d (1575, 2405 kcal/d) in the control group (all P < 0.001)]. The difference in median energy intake (448 kcal/d; 95% CI: 291, 605 kcal/d) was approximately equivalent to a daily dose of the BEP supplement (393 kcal). Nutrient adequacy ratios for both groups were low for all micronutrients (between 0.02 and 0.66), when excluding BEP (except iron and folic acid, due to standard supplemental doses) from analysis. However, nutrient intakes increased to the Estimated Average Requirement for pregnant women when including BEP supplements. CONCLUSIONS: BEP supplementation increases energy and macro- and micronutrient intakes among pregnant women and fills nutrient gaps without displacing food intake. This trial was registered at clinicaltrials.gov as NCT03533712 (https://clinicaltrials.gov/ct2/show/NCT03533712).

Acceptability of 12 fortified balanced energy protein supplements - Insights from Burkina Faso.

Poor maternal nutrition contributes to poor birth outcomes, including low birth weight and small for gestational age births. Fortified balanced energy protein (BEP) supplements may be beneficial, although evidence is limited. This mixed method study, conducted among pregnant women in Burkina Faso, is part of a larger clinical trial that seeks to understand the impact of fortified BEP supplements on pregnancy outcomes and child growth. The formative research reported here, a single-meal rapid assessment of 12 product formulations, sought to understand product preferences for provision of BEP supplements and contextual factors that might affect product acceptability and use. Results indicate a preference for products perceived as sweet rather than salty/savoury and for products perceived as familiar, as well as a sensitivity to product odours. Women expressed a willingness and intention to use the products even if they did not like them, because of the health benefits for their babies. Data also indicate that household food sharing practices may impact supplement use, although most women denied any intention to share the products. Sharing behaviour should therefore be monitored, and strategies to avoid sharing should be developed during the succeeding parts of the research.

Home consumption of two fortified balanced energy protein supplements by pregnant women in Burkina Faso.

Balanced energy protein (BEP) supplementation for pregnant and lactating women in low- and middle-income countries is a promising strategy to improve birth outcomes and child growth. The objective of this study was to assess and compare the acceptability of new formulations of two fortified BEP supplements, a lipid-based peanut paste and a vanilla biscuit, among 80 pregnant women in rural Burkina Faso, prior to an efficacy trial. A 10-week individually randomized cross-over study was designed, in which women received a weekly supply of each supplement for 4 weeks, and a daily choice between the supplements in the last 2 weeks. Questionnaires to assess daily consumption and supplement acceptability (n = 80) and home observations (n = 20) were combined with focus group discussions (n = 6) and in-depth interviews with women (n = 80) and stakeholders (n = 24). Results showed that the two supplements were well accepted. Quantitative findings indicated high compliance (>99.6%) and high overall appreciation (Likert score >6 out of 7) of both supplements. The assessment of preferred choice in Weeks 9 and 10 indicated a slight preference for the vanilla biscuit. Qualitative findings indicated that perceived health benefits, support from household members and educational messages from health professionals were important drivers for acceptance and compliance. Sharing was not often reported but was identified during interviews as a possible risk. We recommend that future studies use a combination of methods to identify appropriate food supplements and context-specific factors that influence acceptability, compliance and subsequent impact of nutritious food supplements.

Can mass media interventions reduce child mortality?

Many people recognise that mass media is important in promoting public health but there have been few attempts to measure how important. An ongoing trial in Burkina Faso (ClinicalTrials.gov, NCT01517230) is an attempt to bring together the very different worlds of mass media and epidemiology: to measure rigorously, using a cluster-randomised design, how many lives mass media can save in a low-income country, and at what cost. Application of the Lives Saved Tool predicts that saturation-based media campaigns could reduce child mortality by 10-20%, at a cost per disability-adjusted life-year that is as low as any existing health intervention. In this Viewpoint we explain the scientific reasoning behind the trial, while stressing the importance of the media methodology used.

Switching the poles in sexual and reproductive health research: implementing a research capacity-strengthening network in West and North Africa.

Health research capacities have been improved in Africa but still remain weak as compared to other regions of the World. To strengthen these research capacities, international collaboration and networking for knowledge and capacity transfer are needed. In this commentary, we present the Network for Scientific Support in the field of Sexual and Reproductive Health in West and North Africa, its priority research topics and discuss its implementation process. Established in January 2014, the Network aims at generating human rights and gender-based research fully carried out and driven by South based institutions. It is composed of 12 institutions including the Institute of Tropical Medicine of Antwerp (Belgium) and 11 institutions from eight Francophone West and North African countries. The key areas of interest of this network are health policies analysis and health system research in family planning, HIV prevention among vulnerable groups, quality of care and breast cancers. Since it started, seventeen research proposals based on locally relevant research questions have been developed. Among the seventeen proposals, eleven have been implemented. Several research institutions enhanced linkages with local representations of international partners such as UNFPA. The network is committed to strengthening methodological research capacities and soft skills such as fundraising, advocacy and leadership. Such competencies are strongly needed for developing an effective South-based leadership in Sexual and Reproductive Health research, and for achieving the Sustainable Development Goals.

A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy-Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol.

Fortified balanced energy-protein (BEP) supplementation is a promising intervention for improving maternal health, birth outcomes and infant growth in low- and middle-income countries. This nested biospecimen sub-study aimed to evaluate the physiological effect of multi-micronutrient-fortified BEP supplementation on pregnant and lactating women and their infants. Pregnant women (15-40 years) received either fortified BEP and iron-folic acid (IFA) (intervention) or IFA only (control) throughout pregnancy. The same women were concurrently randomized to receive either a fortified BEP supplement during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention) or the postnatal standard of care, which comprised IFA alone for 6 weeks postpartum (i.e., control). Biological specimens were collected at different timepoints. Multi-omics profiles will be characterized to assess the mediating effect of BEP supplementation on the different trial arms and its effect on maternal health, as well as birth and infant growth outcomes. The mediating effect of the exposome in the relationship between BEP supplementation and maternal health, birth outcomes and infant growth were characterized via biomonitoring markers of air pollution, mycotoxins and environmental contaminants. The results will provide holistic insight into the granular physiological effects of prenatal and postnatal BEP supplementation.

Challenges of scaling up and of knowledge transfer in an action research project in Burkina Faso to exempt the worst-off from health care user fees.

BACKGROUND: Systems to exempt the indigent from user fees have been put in place to prevent the worst-off from being excluded from health care services for lack of funds. Yet the implementation of these mechanisms is as rare as the operational research on this topic. This article analyzes an action research project aimed at finding an appropriate solution to make health care accessible to the indigent in a rural district of Burkina Faso. RESEARCH: This action research project was initiated in 2007 to study the feasibility and effectiveness of a community-based, participative and financially sustainable process for exempting the indigent from user fees. A interdisciplinary team of researchers from Burkina Faso and Canada was mobilized to document this action research project. RESULTS AND KNOWLEDGE SHARING: The action process was very well received. Indigent selection was effective and strengthened local solidarity, but coverage was reduced by the lack of local financial resources. Furthermore, the indigent have many other needs that cannot be addressed by exemption from user fees. Several knowledge transfer strategies were implemented to share research findings with residents and with local and national decision-makers. PARTNERSHIP ACHIEVEMENTS AND DIFFICULTIES: Using a mixed and interdisciplinary research approach was critical to grasping the complexity of this community-based process. The adoption of the process and the partnership with local decision-makers were very effective. Therefore, at the instigation of an NGO, four other districts in Burkina Faso and Niger reproduced this experiment. However, national decision-makers showed no interest in this action and still seem unconcerned about finding solutions that promote access to health care for the indigent. LESSONS LEARNED: The lessons learned with regard to knowledge transfer and partnerships between researchers and associated decision-makers are: i) involve potential users of the research results from the research planning stage; ii) establish an ongoing partnership between researchers and users; iii) ensure that users can participate in certain research activities; iv) use a variety of strategies to disseminate results; and v) involve users in dissemination activities.

Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial.

INTRODUCTION: Adequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for-gestational-age newborns. There is a probable positive effect of providing pregnant women a balanced energy-protein (BEP) food supplement, but more evidence is needed. The MIcronutriments pour la SAnté de la Mère et de l'Enfant (MISAME) III project aims to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy and lactation in rural Burkina Faso. This paper describes the study protocol. METHODS AND ANALYSIS: MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Houndé. Eligible pregnant women, aged between 15 and 40 years old and living in the study areas, will be enrolled. Women will be randomly assigned to one of the four study groups: (1) prenatal intervention only, (2) postnatal intervention only, (3) prenatal and postnatal intervention or (4) no prenatal or postnatal intervention. The intervention group will receive the BEP supplement and iron/folic acid (IFA) tablets, while the control group will only receive the IFA tablets following the national health protocol. Consumption will be supervised by trained village women on a daily basis by means of home visits. The primary outcomes are small-for-gestational age at birth and length-for-age z-score at 6 months of age. Secondary outcomes will be measured at birth and during the first 6 months of the infants' life. Women will be enrolled from October 2019 until the total sample size is reached. ETHICS AND DISSEMINATION: MISAME-III has been reviewed and approved by the University Hospital of Ghent and the ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained. Results will be published in relevant journals and shared with other researchers and public health institutions. TRIAL REGISTRATION NUMBER: NCT03533712.

Low coverage but few inclusion errors in Burkina Faso: a community-based targeting approach to exempt the indigent from user fees.

BACKGROUND: User fees were generalized in Burkina Faso in the 1990s. At the time of their implementation, it was envisioned that measures would be instituted to exempt the poor from paying these fees. However, in practice, the identification of indigents is ineffective, and so they do not have access to care. Thus, a community-based process for selecting indigents for user fees exemption was tested in a district. In each of the 124 villages in the catchment areas of ten health centres, village committees proposed lists of indigents that were then validated by the health centres' management committees. The objective of this study is to evaluate the effectiveness of this community-based selection. METHODS: An indigent-selection process is judged effective if it minimizes inclusion biases and exclusion biases. The study compares the levels of poverty and of vulnerability of indigents selected by the management committees (n = 184) with: 1) indigents selected in the villages but not retained by these committees (n = 48); ii) indigents selected by the health centre nurses (n = 82); and iii) a sample of the rural population (n = 5,900). RESULTS: The households in which the three groups of indigents lived appeared to be more vulnerable and poorer than the reference rural households. Indigents selected by the management committees and the nurses were very comparable in terms of levels of vulnerability, but the former were more vulnerable socially. The majority of indigents proposed by the village committees who lived in extremely poor households were retained by the management committees. Only 0.36% of the population living below the poverty threshold and less than 1% of the extremely poor population were selected. CONCLUSIONS: The community-based process minimized inclusion biases, as the people selected were poorer and more vulnerable than the rest of the population. However, there were significant exclusion biases; the selection was very restrictive because the exemption had to be endogenously funded.

Assessing the repeatability of verbal autopsy for determining cause of death: two case studies among women of reproductive age in Burkina Faso and Indonesia.

BACKGROUND: Verbal autopsy (VA) is an established tool for assessing cause-specific mortality patterns in communities where deaths are not routinely medically certified, and is an important source of data on deaths among the poorer half of the world's population. However, the repeatability of the VA process has never been investigated, even though it is an important factor in its overall validity. This study analyses repeatability in terms of the overall VA process (from interview to cause-specific mortality fractions (CSMF)), as well as specifically for interview material and individual causes of death, using data from Burkina Faso and Indonesia. METHODS: Two series of repeated VA interviews relating to women of reproductive age in Burkina Faso (n = 91) and Indonesia (n = 116) were analysed for repeatability in terms of interview material, individual causes of death and CSMFs. All the VA data were interpreted using the InterVA-M model, which provides 100% intrinsic repeatability for interpretation, and thus eliminated the need to consider variations or repeatability in physician coding. RESULTS: The repeatability of the overall VA process from interview to CSMFs was good in both countries. Repeatability was moderate in the interview material, and lower in terms of individual causes of death. Burkinabé data were less repeatable than Indonesian, and repeatability also declined with longer recall periods between the death and interview, particularly after two years. CONCLUSION: While these analyses do not address the validity of the VA process in absolute terms, repeatability is a prerequisite for intrinsic validity. This study thus adds new understanding to the quest for reliable cause of death assessment in communities lacking routine medical certification of deaths, and confirms the status of VA as an important and reliable tool at the community level, but perhaps less so at the individual level.

Direct data capture using hand-held computers in rural Burkina Faso: experiences, benefits and lessons learnt.

OBJECTIVES: To assess our experiences of using hand-held computers (personal digital assistants, PDAs) for direct data capture in a large community-based geo-referenced survey in rural Burkina Faso, highlighting benefits and lessons learnt from their use. METHODS: A population-based geo-referenced survey of over 500 000 people was undertaken using PDAs with in-built GPS receivers and the resulting database analysed in terms of successful completion, error rates and interview durations. RESULTS: Surveys were successfully completed for 84 861 households (98.3%) by 127 interviewers. The data input error rate was assessed at 0.24%, with more than half of the errors being made by less than 10% of the interviewers. Faster interviewers were not less accurate. Time-stamped and geo-referenced data allowed reconstruction of particular interviewer-day activities. CONCLUSIONS: Although the survey setting was challenging, the feasibility of using direct data capture on a large scale was well established. We learnt that, with more experience, we could have made better use of real-time entry and quality control checking procedures. The work involved in designing and setting up a complex survey on PDAs prior to data collection should not be underestimated.

Effects of a Skilled Care Initiative on pregnancy-related mortality in rural Burkina Faso.

OBJECTIVE: The aim of this paper is to assess to what extent a Skilled Care Initiative (SCI) was associated with pregnancy-related mortality in Ouargaye district, Burkina Faso. METHODS: We used a quasi-experimental design to compare pregnancy-related mortality within the intervention district (health facility areas covered by the SCI vs. areas not covered) and between the intervention district (Ouargaye) and a comparison district (Diapaga). Population-based data were used to examine differences in pregnancy-related mortality levels, their determinants and how they related to uptake of care, as well as examining contexts and mechanisms of pregnancy-related deaths that occurred. Data analyses included descriptive statistics, univariate and multivariate regression analyses. RESULTS: The main risk factors for pregnancy-related mortality in rural Burkina Faso were age (extreme ages of reproductive period), low coverage of antenatal care and low institutional delivery. The introduction of the SCI, as implemented within the study reference period, had no appreciable effect on pregnancy-related mortality. CONCLUSION: Although the SCI was conceptually well designed and implemented, structural constraints may have limited its effectiveness for reducing pregnancy-related mortality within its period of implementation. Lessons have been identified which might enable similar skilled attendance strategies to make their full potential impact on pregnancy-related mortality in remote and rural settings.

The epidemiology of pregnancy outcomes in rural Burkina Faso.

OBJECTIVES: To describe levels and causes of pregnancy-related mortality and selected outcomes after pregnancy (OAP) in two districts of Burkina Faso. METHODS: A household census was conducted in the two study districts, recording household deaths to women aged 12-49 years from 2001 to 2006. Questions on pregnancy outcomes in the last 5 years for resident women of reproductive age were included, and an additional method - direct sisterhood - was added in part of the area. Adult female deaths were followed-up with verbal autopsies (VA) with household members. A probabilistic model for interpreting VA data (InterVA-M) was used to determine distributions of probable causes of death. An OAP survey was conducted among all women with an experience of pregnancy during the prior 12 months. It aimed to document physical and psychological disabilities, economic and social consequences and discomfort that women may suffer as a result of a pregnancy. RESULTS: The maternal mortality ratio (MMR) was 441 per 100 000 live births (95% CI: 397, 485), significantly higher in Diapaga [519 per 100 000 (95% CI: 454, 584)] than Ouargaye [353 per 100 000 (95% CI: 295, 411)]. MMRs were associated with wealth quintile, age and distance from a health facility. The causes of death showed higher than expected rates of sepsis (30%) and lower rates of haemorrhage (7%). A substantial proportion of all women had difficulty performing day-to-day tasks as a consequence of pregnancy. Women who had experienced stillbirths or Caesarean sections reported symptom-related indicators of poor physical health more frequently than women reporting uncomplicated deliveries, and were also more likely to be depressed. CONCLUSIONS: Expectations on the levels and causes of pregnancy-related mortality in Burkina Faso may need to be re-examined, and this could have programmatic implications; for example high levels of sepsis could prompt renewed efforts to reach women with skilled attendance at delivery and follow-up during the postpartum period. Further documentation of how complication-induced disabilities affect women and their families is needed. For mortality and morbidity outcomes, demonstrating variation between study districts is important to empower local decision makers with evidence of need at a subnational level.

Maternal death due to postpartum hemorrhage after snakebite.

A case of fatal postpartum hemorrhage demonstrates the need for the immediate referral of all pregnant women who incur a snakebite.