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Labrique A.B.,Johns Hopkins University | Christian P.,Johns Hopkins University | Klemm R.D.W.,Johns Hopkins University | Rashid M.,The JiVitA Maternal and Child Health and Nutrition Research Project | And 5 more authors.
Trials | Year: 2011

Background: We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field.Methods: This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies.Results: The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age.Conclusion: Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822. © 2011 Labrique et al; licensee BioMed Central Ltd. Source

Sundaram M.E.,Johns Hopkins University | Sundaram M.E.,Marshfield Clinic Research Foundation | Labrique A.B.,Johns Hopkins University | Mehra S.,Johns Hopkins University | And 5 more authors.
Journal of Nutrition | Year: 2013

Exclusive breastfeeding of newborns, a practice recommended by WHO, is hindered in many countries by practices such as prelacteal feeding (feeding other foods before breast milk is fed to infants). This paper describes maternal and infant characteristics and trends over time associated with early neonatal feeding (ENF) in Bangladesh. The analysis used data from 24,992 participants in a randomized controlled trial supplementing vitamin A and β-carotene to women in northwestern rural Bangladesh. A majority of newborns (89.2%) were fed substances other than breast milk in the first 3 d of life. Early neonatal feeding practices were found to be significantly associated with lower maternal education, higher gravidity, lower socioeconomic status, and younger maternal age. A perceived inability to suckle normally after birth was closely related to the risk of an infant being fed a food other than breast milk in the first 3 d of life [OR = 0.09 (95%CI: 0.08, 0.11)]. Only 18.8% of newborns fed an early neonatal food were exclusively breastfed between 3 d and 3 mo postpartum compared with 70.6% of those not fed an early neonatal food during this period (P < 0.05). Early neonatal feeding practices should be addressed when scaling-up exclusive breastfeeding in South Asia. Maternal education, antenatal care, and support during labor and delivery may help reduce ENF and promote exclusive breastfeeding. © 2013 American Society for Nutrition. Source

Gernand A.D.,Center for Human Nutrition | Christian P.,Center for Human Nutrition | Paul R.R.,The JiVitA Maternal and Child Health and Nutrition Research Project | Shaikh S.,The JiVitA Maternal and Child Health and Nutrition Research Project | And 4 more authors.
Journal of Nutrition | Year: 2012

Placental growth is a strong predictor of fetal growth, but little is known about maternal predictors of placental growth in malnourished populations. Our objective was to investigate in a prospective study the associations of maternal weight and body composition [total body water (TBW) estimated by bioelectrical impedance and fat and fat-free mass derived from upper arm fat and muscle areas (UAFA, UAMA)] and changes in these with placental and birth weights. Within a cluster- randomized trial of maternal micronutrient supplementation, a subsample of 350 women was measured 3 times across gestation. Longitudinal analysis was used to examine independent associations of;10-wk measurements and;10-20wk and;20-32wk changes with birth outcomes. Weight, TBW, and UAMA, but not UAFA, at;10wk were each positively and independently associated with placental weight and birth weight (P < 0.05). Of the maternal;10-20wk changes in measurements, only TBW change and placental weight, and maternal weight and birth weight were positively associated (P < 0.05). Gains in weight, TBW, and UAMA from 20 to 32wk were positively and UAFA gain was negatively associated with placental weight (P # 0.01). Gains in weight and UAMA from 20 to 32wk were positively associated with birth weight (P # 0.01). Overall, higher maternal weight and measures of fat-free mass at;10wk gestation and gains from 20 to 32wk are independently associated with higher placental and birth weight. © 2012 American Society for Nutrition. Source

Francesconi K.,University of Graz | Gossler W.,University of Graz | Schulze K.,The JiVitA Maternal and Child Health and Nutrition Research Project | Mehra S.,The JiVitA Maternal and Child Health and Nutrition Research Project | And 8 more authors.
Environmental Research | Year: 2015

Background: Arsenic has immunomodulatory properties and may have the potential to alter susceptibility to infection in humans. Objectives: We aimed to assess the relation of arsenic exposure during pregnancy with immune function and hepatitis E virus (HEV) infection, defined as seroconversion during pregnancy and postpartum. Methods: We assessed IgG seroconversion to HEV between 1st and 3rd trimester (TM) and 3 months postpartum (PP) among 1100 pregnancies in a multiple micronutrient supplementation trial in rural Bangladesh. Forty women seroconverted to HEV and were matched with 40 non-seroconverting women (controls) by age, parity and intervention. We assessed urinary inorganic arsenic plus methylated species (∑As) (μg/L) at 1st and 3rd TM and plasma cytokines (pg/mL) at 1st and 3rd TM and 3 months PP. Results: HEV seroconverters' urinary ∑As was elevated throughout pregnancy. Non-seroconverters' urinary ∑As was similar to HEV seroconverters at 1st TM but declined at 3rd TM. The adjusted odds ratio (95% confidence interval) of HEV seroconversion was 2.17 (1.07, 4.39) per interquartile range (IQR) increase in average-pregnancy urinary ∑As. Increased urinary ∑As was associated with increased concentrations of IL-2 during the 1st and 3rd TM and 3 months PP among HEV seroconverters but not non-seroconverters. Conclusions: The relation of urinary arsenic during pregnancy with incident HEV seroconversion and with IL-2 levels among HEV-seroconverting pregnant women suggests arsenic exposure during pregnancy may enhance susceptibility to HEV infection. © 2015 Elsevier Inc. Source

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