Seasonal and District Level Geo-Spatial Variations in Stillbirth Rates in India: An Analysis of Secondary Data.

Stillbirth is a major public health problem across the world as well as in India. The programmatic interventions to tackle stillbirth require granular data upto local levels. The Health Management Information System (HMIS) in India is one of the best sources of granular data on stillbirth. This analysis was conducted using HMIS stillbirth data of three pre-pandemic years 2017-2020 to study the geo-spatial patterns of stillbirth at district level in nine states of India, forming a high burden cluster of four central Indian states and a low burden cluster of five southern states. Geo-spatial variation at sub-district level was studied for Maharashtra given the ready availability of sub-district shapefiles required for such analysis. The analysis also explores the seasonal variations in stillbirths at all-India level. A granular intra-cluster spatial pattern of stillbirth was observed in all states analyzed, with a clear hotspot across a few districts in Odisha and Chhattisgarh (>20 stillbirths/1,000 total births in 2019-20). Even in the southern cluster, the hotspots (8-20 stillbirths/1,000 total births) were found. Availability of sub-district level data in Maharashtra helped to identify intra-state regional variations in stillbirth with high prevalence in certain district clusters. In temporal terms, stillbirths exhibit a regular peak during August-October and a dip during February-April which is inclined with the birth seasonality patterns. This review and analysis underscore the need for more granular data availability, regular analysis of such data by expert and program managers, more decentralized and context specific programme intervention both in locational and seasonal terms.

Stillbirth rates and its spatial patterns in India: an exploration of HMIS data.

Background: High prevalence of stillbirths is a significant concern for the health system of India. This necessitates a closer scrutiny of the prevalence, spatial pattern and the risk factors of stillbirth at both national and local level. Methods: We analysed stillbirth data of three financial years (April 2017-March 2020) from Health Management Information System (HMIS) of India which provides majorly public facility level data for stillbirths up to the district level on a monthly basis. National and state level prevalence of stillbirth rate (SBR) were estimated. Spatial patterns of SBR at district level was identified using local indicator of spatial association (LISA). Risk factors of stillbirths were studied by triangulation of HMIS and National Family Health Survey (NFHS-4) data using bivariate LISA. Findings: National average of SBR in 2017-18, 2018-2019 and 2019-2020 are 13.4 [4.2-24.2], 13.1 [4.2-22.2] and 12.4 [3.7-22.5] respectively. Districts of Odisha, Madhya Pradesh, Rajasthan and Chhattisgarh (OMRC) form a contiguous east-west belt of high SBR. Body mass index (BMI) of the mother, antenatal care (ANC), maternal anemia, iron-folic acid (IFA) supplementation and institutional delivery show significant spatial autocorrelation with SBR. Interpretation: Maternal and child health programme delivery should prioritise targeted intervention in the hotspot clusters of high SBR, considering the locally significant determinants. The findings show inter alia, the need to focus on ANC to reduce stillbirth in India. Funding: The study is not funded.

A Randomized Trial of Quadruple-Fortified Salt for Anemia and Birth Defects Prevention in Southern India: Protocol Design and Methods.

Background: Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects (NTDs) and other pregnancy complications. Vitamin B12 deficiency is a risk factor for NTDs and may modify folate biomarkers that predict NTD risk at the population level. There is an interest in mandatory fortification with vitamin B12 and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. Objectives: This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B12) in 1,000 households in Southern India. Methods: Women 18 to 49 y who are not pregnant or lactating and reside within the catchment area of our community-based research site in Southern India will be screened and invited to participate in the trial. After informed consent, women and their households will be randomized to receive one of the following 4 interventions: 1) double-fortified salt (DFS; iron, iodine), 2) DFS + folic acid (iron, iodine, folic acid), 3) DFS + vitamin B12 (iron, iodine, vitamin B12), or 4) DFS + folic acid and vitamin B12 (QFS; iron, iodine, folic acid, vitamin B12) for 12 mo. Structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, anthropometric, dietary, health, and reproductive history data. Biological samples will be collected at baseline, midpoint, and endpoint. Whole blood will be analyzed for hemoglobin using Coulter Counter. Total vitamin B12 will be measured by chemiluminescence; red blood cell folate and serum folate will be evaluated using the World Health Organization-recommended microbiologic assay. Conclusions: The results of this randomized trial will help to evaluate the efficacy of QFS to prevent anemia and micronutrient deficiencies. Clinical trial registration numbers: NCT03853304 and Clinical Trial Registry of India REF/2019/03/024479. Registration number: NCT03853304 and REF/2019/03/024479.

Guava with an institutional supplementary meal improves iron status of preschoolers: a cluster-randomized controlled trial.

The Integrated Child Development Services of India provides Supplementary Nutrition Program (SNP) to preschoolers. Using this platform, the current study examined the impact of diversifying a cereal/pulse-based SNP-meal with guava on iron status and cognitive development among 24-48 months old children. A three-arm, nonblinded, cluster-randomized controlled trial (CTRI/2014/09/004983) included 399 beneficiaries from 28 preschools in 16 villages in Telangana state, India. The villages were randomly assigned to receive 25 g of guava (guava group (GG)), banana (banana group (BG)), or cucumber (cucumber group (CG)) along with a SNP meal for 140 days. Nutrient biomarkers (iron status, plasma vitamin C, vitamin B12 , and folate), cognitive development, anthropometric indicators (WAZ, HAZ, and WHZ), and morbidity were assessed at baseline and endline. A linear mixed model and a generalized estimating equation were applied to compare changes in outcomes across the groups. All outcome variables were comparable across groups at baseline. The iron to vitamin C molar ratio improved in the GG from 1:1.4 to 1:12 but remained unaltered in control groups. Higher hemoglobin (P = 0.002), serum ferritin (SF; P < 0.001), vitamin C (P = 0.047), and lower soluble transferrin receptor (sTfR; P < 0.001) causing decreased prevalence of iron deficiency (ID) (P = 0.003) were observed in the GG compared with BG and CG. Prevalence of acute respiratory infection (ARI) was lower in the GG (P = 0.035) versus controls. No impact was observed on cognitive development or growth. Thus, diversifying a cereal/pulse-based meal with guava increased meal vitamin C content, thereby reducing ID and ARI-related morbidity. This approach represents a valid and scalable strategy to address ID among young children.

A food synergy approach in a national program to improve the micronutrient status of preschoolers: a randomized control trial protocol.

Iron deficiency anemia (IDA) is a significant public health issue in India affecting nearly all vulnerable segments of the population. Causes of IDA include low consumption of iron-rich foods combined with poor iron bioavailability of nonheme iron sources. To date, interventions aimed at correcting IDA focus on increasing iron intake through iron supplementation or fortification strategies. In contrast, dietary diversification is a long-term sustainable approach to improve bioavailable iron intake. In this context, the inclusion of vitamin C-rich fruits in the regular diet has proven to improve iron absorption, but the effect on iron status is inconclusive. Considering the ongoing national program for preschoolers in India, we designed a cluster randomized controlled trial (RCT) to test the hypothesis that inclusion of vitamin C-rich fruit in a regular meal would improve iron absorption and lead to better child iron and micronutrient status, cognitive development, gut health, and growth while reducing morbidity. This paper illustrates a context-specific framework and activities to design and functionalize an open-label, three-arm cluster RCT to test a specific hypothesis. The results of this designed trial should generate evidence to inform policy on the effect of a food-based intervention on iron status.