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Background: Globally, 144 million children under 5 years are undernourished and 250 million do not meet their developmental potential. Multi-input interventions, such as bundled nutrition and parenting interventions, are designed to mitigate risks for multiple child outcomes. There is limited evidence that bundled interventions have additive benefits to nutrition, growth, or development outcomes. These outcomes share common risks; therefore, designing interventions to tackle these risks using a common theory of change may optimize effectiveness. Emerging evidence suggests explicit engagement of fathers may benefit child outcomes, but few trials have tested this or included data collected from fathers. Methods: Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS) is a community-based cluster-randomized controlled trial that will be implemented in the rural Mara Region, Tanzania. The trial aims (1) to test a bundled nutrition and parenting program delivered to mothers' groups, with or without fathers' groups, over 12 months on child and caregiving outcomes compared to a nutrition program alone, and (2) to test nutrition or bundled nutrition and parenting programs delivered to mothers' and fathers' groups over 12 months on child and caregiving outcomes compared to programs delivered to mothers alone. The trial comprises five arms: (1) mothers' groups receiving a nutrition program, (2) mothers' groups receiving a bundled nutrition and parenting program, (3) mothers' and fathers' groups receiving a nutrition program, (4) mothers' and fathers' groups receiving a bundled nutrition and parenting program, and (5) control receiving standard of care health services. The primary outcomes are child dietary diversity and early child development (mental and motor development). Parents with a child under 18 months will be enrolled in peer groups and receive twice monthly intervention by trained community health workers. Data will be collected from mothers, fathers, and children at baseline (pre-intervention), midline, and endline (post-intervention). Discussion: EFFECTS will generate evidence on the effects of bundled nutrition and parenting interventions on child nutrition, growth, and development outcomes; determine the benefits of engaging fathers on child, caregiving, and caregiver outcomes; and investigate common and unique pathways between treatments and child outcomes. Trial registration: ClinicalTrials.gov NCT03759821. Registered on November 30, 2018 [ABSTRACT FROM AUTHOR]

Background There is limited data available regarding safety profile of artemisinins in early pregnancy. They are, therefore, not recommended by WHO as a first-line treatment for malaria in first trimester due to associated embryo-foetal toxicity in animal studies. The study assessed birth outcome among pregnant women inadvertently exposed to artemether-lumefantrine (AL) during first trimester in comparison to those of women exposed to other anti-malarial drugs or no drug at all during the same period of pregnancy. Methods Pregnant women with gestational age <20 weeks were recruited from Maternal Health clinics or from monthly house visits (demographic surveillance), and followed prospectively until delivery. Results 2167 pregnant women were recruited and 1783 (82.3%) completed the study until delivery. 319 (17.9%) used anti-malarials in first trimester, of whom 172 (53.9%) used (AL), 78 (24.4%) quinine, 66 (20.7%) sulphadoxine-pyrimethamine (SP) and 11 (3.4%) amodiaquine. Quinine exposure in first trimester was associated with an increased risk of miscarriage/stillbirth (OR 2.5; 1.3-5.1) and premature birth (OR 2.6; 1.3-5.3) as opposed to AL with (OR 1.4; 0.8-2.5) for miscarriage/stillbirth and (OR 0.9; 0.5-1.8) for preterm birth. Congenital anomalies were identified in 4 exposure groups namely AL only (1/164[0.6%]), quinine only (1/70[1.4%]), SP (2/66[3.0%]), and non-anti-malarial exposure group (19/1464[1.3%]). Conclusion Exposure to AL in first trimester was more common than to any other anti-malarial drugs. Quinine exposure was associated with adverse pregnancy outcomes which was not the case following other anti-malarial intake. Since AL and quinine were used according to their availability rather than to disease severity, it is likely that the effect observed was related to the drug and not to the disease itself. Even with this caveat, a change of policy from quinine to AL for the treatment of uncomplicated malaria during the whole pregnancy period could be already envisaged. [ABSTRACT FROM AUTHOR]

Background: There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy. Methods: Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome. Results: 1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08 - 0.3). Conclusion: Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines. [ABSTRACT FROM AUTHOR]

Background: Poorly spaced pregnancies have been documented worldwide to result in adverse maternal and child health outcomes. The World Health Organization (WHO) recommends a minimum inter-birth interval of 33 months between two consecutive live births in order to reduce the risk of adverse maternal and child health outcomes. However, birth spacing practices in many developing countries, including Tanzania, remain scantly addressed. Methods: Longitudinal data collected in the Rufiji Health and Demographic Surveillance System (HDSS) from January 1999 to December 2010 were analyzed to investigate birth spacing practices among women of childbearing age. The outcome variable, non-adherence to the minimum inter-birth interval, constituted all inter-birth intervals <33 months long. Inter-birth intervals ⩾33 months long were considered to be adherent to the recommendation. Chi-Square was used as a test of association between non-adherence and each of the explanatory variables. Factors affecting non-adherence were identified using a multilevel logistic model. Data analysis was conducted using STATA (11) statistical software. Results: A total of 15,373 inter-birth intervals were recorded from 8,980 women aged 15-49 years in Rufiji district over the follow-up period of 11 years. The median inter-birth interval was 33.4 months. Of the 15,373 inter-birth intervals, 48.4% were below the WHO recommended minimum length of 33 months between two live births. Non-adherence was associated with younger maternal age, low maternal education, multiple births from the preceding pregnancy, non-health facility delivery of the preceding birth, being an in-migrant resident, multi-parity and being married. Conclusion: Generally, one in every two inter-birth intervals among 15-49 year-old women in Rufiji district is poorly spaced, with significant variations by socio-demographic and behavioral characteristics of mothers and newborns. Maternal, newborn and child health services should be improved with a special emphasis on community- and health facility-based optimum birth spacing education in order to enhance health outcomes of mothers and their babies, especially in rural settings. [ABSTRACT FROM AUTHOR]

Background: Nutrition-sensitive interventions such as homestead production of diverse, nutrient-rich foods, coupled with behavior change communication, may have positive effects on the nutritional status and health of rural households engaged in agriculture, particularly among women and young children. Engagement of agriculture and health extension workers in these communities may be an effective way of delivering nutrition-sensitive interventions given the dearth of trained health care providers in many developing countries. This study aims to assess the effects of integrated homestead food production, food consumption and women’s empowerment interventions using a multi-sectoral approach on women’s and child’s health and nutrition. Methods: This is a cluster-randomized community-based prospective study set in Rufiji district, a rural area in Eastern Tanzania. Ten randomly selected villages within the Rufiji Health and Demographic Surveillance Site (HDSS) in Eastern-Tanzania were paired and randomly assigned to the intervention or control arm. The Rufiji HDSS dataset was used to randomly sample households with women of reproductive age and children 6–36 months. The intervention includes provision of small agricultural inputs, garden training support, and nutrition and health counseling. This is delivered by community health workers and agriculture extension workers through home visits and farmer field schools. There are three time points for data collection: baseline, midline, and endline. Primary outcomes are women’s and children’s dietary diversity, maternal and child anemia status and growth (child stunting, child wasting, women’s BMI, and women and child hemoglobin). Discussion: This integrated agriculture and nutrition intervention among rural farming households is a simple and innovative solution that may contribute to the reduction of undernutrition and disease burden among women and children in developing countries. Engaging already existing workforce in the community may facilitate sustainability of the intervention package. Trial registration: ClinicalTrials.gov NCT03311698, Retrospectively registered on October 17, 2017. [ABSTRACT FROM AUTHOR]

Background: Blood transfusion (BT) can be lifesaving for children; however, monitoring the quality of BT is important. The current study describes the quality of paediatric BT delivered in two district hospitals in north-east Tanzania in order to identify areas for quality assurance and improvement in the administration of BT.Methods: All 166 children admitted in the paediatric wards and receiving BT through April to June 2007 were prospectively observed. Medical records, request forms and registers in the laboratories were reviewed to identify blood source, blood screening and indications for BT. BT was observation before, during and after transfusion process.Results: Malaria related anaemia accounted for 98% of the BTs. Ninety-two percent of the children were assessed for paleness. Clinical signs such as difficult breathing and symptoms of cardiac failure were only assessed in 67% and 15% of the children respectively, prior to the BT decision. Pre-transfusion haemoglobin and body temperature were recorded in 2/3 of the patients, but respiratory rate and pulse rate were not routinely recorded. In 40% of BTs, the transfusion time exceeded the recommended 4 hours. The zonal blood bank (ZBB) and local donors accounted for 10% and 90% of the blood, respectively. ABO and RhD typing and screening for HIV and syphilis were undertaken in all transfused blood. Evidence for hepatitis B or C infection was not checked except in the ZBB.Conclusion: Criteria for BT are not always fulfilled; time to initiate and complete the transfusion is often unacceptable long and monitoring of vital signs during BT is poor. Blood from the ZBB was often not available and BT often depended on local donors which implied lack of screening for hepatitis B and C. It is recommended that an external supervision system be established to monitor and evaluate the quality of BT performance in the laboratories as well as in wards. [ABSTRACT FROM AUTHOR]