113 results on '"Dharma S. Manandhar"'
Search Results
102. The effects of postnatal health education for mothers on infant care and family planning practices in Nepal: a randomised controlled trial
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Dharma S Manandhar, Purna Shrestha, Alison Bolam, Anthony Costello, and Matthew Ellis
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Male ,medicine.medical_specialty ,genetic structures ,Psychological intervention ,Nutritional Status ,Prenatal care ,Nepal ,Nursing ,Pregnancy ,medicine ,Humans ,Infant Nutritional Physiological Phenomena ,Contraception Behavior ,Health Education ,General Environmental Science ,business.industry ,Public health ,Infant Care ,Infant, Newborn ,General Engineering ,Infant ,Prenatal Care ,General Medicine ,Prognosis ,Breast Feeding ,Health promotion ,Family planning ,Family Planning Services ,Family medicine ,Papers ,General Earth and Planetary Sciences ,Female ,Immunization ,Perception ,Health education ,business ,Breast feeding ,Follow-Up Studies - Abstract
Objectives: To evaluate impact of postnatal health education for mothers on infant care and postnatal family planning practices in Nepal. Design: Randomised controlled trial with community follow up at 3 and 6 months post partum by interview. Initial household survey of study areas to identify all pregnant women to facilitate follow up. Setting: Main maternity hospital in Kathmandu, Nepal. Follow up in urban Kathmandu and a periurban area southwest of the city. Subjects: 540 mothers randomly allocated to one of four groups: health education immediately after birth and three months later (group A), at birth only (group B), at three months only (group C), or none (group D). Interventions: Structured baseline household questionnaire; 20 minute, one to one health education at birth and three months later. Main outcome measures: Duration of exclusive breast feeding, appropriate immunisation of infant, knowledge of oral rehydration solution and need to continue breast feeding in diarrhoea, knowledge of infant signs suggesting pneumonia, uptake of postnatal family planning. Results: Mothers in groups A and B (received health education at birth) were slightly more likely to use contraception at six months after birth compared with mothers in groups C and D (no health education at birth) (odds ratio 1.62, 95% confidence interval 1.06 to 2.5). There were no other significant differences between groups with regards to infant feeding, infant care, or immunisation. Conclusions: Our findings suggest that the recommended practice of individual health education for postnatal mothers in poor communities has no impact on infant feeding, care, or immunisation, although uptake of family planning may be slightly enhanced. Key messages Health education is widely promoted in primary care, but there have been few rigorous evaluations of its impact, especially in developing countries A randomised controlled trial of postnatal individual health education for mothers given by trained female health workers showed no significant impact on maternal knowledge and practices of child care or on infant health outcomes, but there was a small improvement in uptake of family planning at six months after birth The efficacy of health education interventions that rely solely on giving people information to bring about a change in health behaviour is unproved; interventions should be evaluated before being implemented on a large scale Alternative strategies for health promotion in developing countries such as interactions within families, peer groups, or communities may be more effective but are costly and difficult to implement on a large scale
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- 1998
103. Micronutrient supplementation in pregnancy – Authors' response
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Dharma S Manandhar, Anthony Costello, David Osrin, Parul Christian, Keith P. West, and Subarna K. Khatry
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Pregnancy ,business.industry ,Physiology ,Medicine ,General Medicine ,business ,medicine.disease ,Micronutrient - Published
- 2005
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104. Antenatal micronutrient supplements in Nepal
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Subarna K. Khatry, David Osrin, Anthony Costello, Dharma S Manandhar, Parul Christian, and Keith P. West
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medicine.medical_specialty ,Pediatrics ,Iron ,Birth weight ,MEDLINE ,Prenatal care ,Double blind ,Folic Acid ,Nepal ,Pregnancy ,Infant Mortality ,medicine ,Birth Weight ,Humans ,Maternal health ,Micronutrients ,Obstetrics ,business.industry ,Infant, Newborn ,Pregnancy Outcome ,Prenatal Care ,General Medicine ,Micronutrient ,medicine.disease ,Infant mortality ,Dietary Supplements ,Female ,business - Published
- 2005
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105. Association between Clean Delivery Kit Use, Clean Delivery Practices, and Neonatal Survival: Pooled Analysis of Data from Three Sites in South Asia
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Prasanta Tripathy, Anni-Maria Pulkki-Brännström, Nirmala Nair, Anthony Costello, Tanja A. J. Houweling, Kishwar Azad, David Osrin, Leah Li, Joanna Morrison, Dharma S Manandhar, Nadine Seward, and Audrey Prost
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Rural Population ,Health Knowledge, Attitudes, Practice ,Hand washing ,Pediatrics ,medicine.medical_specialty ,Epidemiology ,Population ,lcsh:Medicine ,India ,Global Health ,Midwifery ,03 medical and health sciences ,0302 clinical medicine ,Nepal ,Pregnancy ,Sepsis ,Survivorship curve ,Environmental health ,Infant Mortality ,Cluster Analysis ,Humans ,Medicine ,Childbirth ,030212 general & internal medicine ,education ,Home Childbirth ,Bangladesh ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Neonatal sepsis ,business.industry ,Mortality rate ,lcsh:R ,Infant, Newborn ,1. No poverty ,Obstetrics and Gynecology ,Public Health, Global Health, Social Medicine and Epidemiology ,General Medicine ,Odds ratio ,Delivery, Obstetric ,medicine.disease ,Infant mortality ,3. Good health ,Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi ,Female ,business ,Research Article - Abstract
A pooled analysis of data from three studies in South Asia demonstrates an association between use of clean delivery kits during home births and reduced risk of neonatal mortality., Background Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births. Methods and Findings Hierarchical, logistic regression models were used to explore the association between neonatal mortality and clean delivery kit use or clean delivery practices in 19,754 home births, controlling for confounders common to all study sites. We tested the association between kit use and neonatal mortality using a pooled dataset from all three sites and separately for each site. We then examined the association between individual clean delivery practices addressed in the contents of the kit (boiled blade and thread, plastic sheet, gloves, hand washing, and appropriate cord care) and neonatal mortality. Finally, we examined the combined association between mortality and four specific clean delivery practices (boiled blade and thread, hand washing, and plastic sheet). Using the pooled dataset, we found that kit use was associated with a relative reduction in neonatal mortality (adjusted odds ratio 0.52, 95% CI 0.39–0.68). While use of a clean delivery kit was not always accompanied by clean delivery practices, using a plastic sheet during delivery, a boiled blade to cut the cord, a boiled thread to tie the cord, and antiseptic to clean the umbilicus were each significantly associated with relative reductions in mortality, independently of kit use. Each additional clean delivery practice used was associated with a 16% relative reduction in neonatal mortality (odds ratio 0.84, 95% CI 0.77–0.92). Conclusions The appropriate use of a clean delivery kit or clean delivery practices is associated with relative reductions in neonatal mortality among home births in underserved, rural populations. Please see later in the article for the Editors' Summary, Editors' Summary Background Worldwide, around 3.3 million babies die in the first month of life, according to data for 2009 from the World Health Organization. Although the global neonatal mortality rate declined by 28% (from 33.2 deaths per 1,000 live births to 23.9) between 1990 and 2009, the proportion of child deaths that are now in the neonatal period has increased in all regions of the world, and currently stands at 41%. This figure is concerning and neonatal mortality remains a big obstacle to the international community in meeting the target of Millennium Development Goal 4—to reduce deaths in children under 5 years by two-thirds from 1990 levels by 2015. At least 15% of all neonatal deaths are due to sepsis (systematic bacterial infection) and an estimated 30%–40% of infections are transmitted at the time of birth. Therefore preventing infections through clean delivery practices is an important strategy to reduce sepsis-related deaths in newborns and can contribute to reducing the overall burden of neonatal deaths. Why Was This Study Done? In South Asia, around 65% of deliveries occur at home, without skilled birth attendants, making practices around clean delivery particularly challenging. To date, evidence on the impact of clean delivery kits and clean delivery practices on neonatal mortality or sepsis-related neonatal deaths from community-based studies is scarce. In this study the researchers explored the associations between neonatal mortality, the use of clean delivery kits, and individual clean delivery practices by using data from the control arms of three cluster-randomized controlled trials conducted among rural populations in South Asia. What Did the Researchers Do and Find? The researchers used data from almost 20,000 (19,754) home births available from the control arms of three community-based cluster-randomized trials conducted between 2000 and 2008 in India (n = 6,841, 18 clusters), Bangladesh (n = 7,041, five clusters), and Nepal (n = 5,872, five clusters). The researchers did not include data from other previously conducted trials on clean delivery practices because of the mix of designs used in these studies and limited their analysis to live-born singleton infants delivered at home in control areas, for whom data on birth kit use were available. The researchers conducted a separate analysis for each country on kit use and clean delivery practices and also analyzed the pooled dataset for all countries while controlling for factors about the mother, the pregnancy, the delivery, and the postnatal period. Using these methods, the researchers found that kits were used for 18.4% of home births in India, 18.4% in Bangladesh, and 5.7% in Nepal. Importantly, according to the pooled analysis, kit use was associated with a 48% relative reduction in neonatal mortality (odds ratio/chance 0.52), which was similar across all countries: 57% relative reduction in neonatal mortality in India, 32% in Bangladesh, and 49% in Nepal. Delivery practices were also important: in the pooled country analysis, the use of a boiled blade to cut the cord, antiseptic to clean the cord, a boiled thread to tie the cord, and a plastic sheet for a clean delivery surface were all associated with significant relative reductions in mortality after controlling for kit use and confounders common to all sites. The researchers found a 16% relative reduction in mortality with each additional clean delivery practice used. What Do These Findings Mean? These findings show that the appropriate use of a clean delivery kit and clean delivery practices could lead to substantial reductions in neonatal mortality among home births in poor rural communities with limited access to health care. The results also reinforce the importance of each clean delivery practice; hand washing and use of a sterilised blade, boiled thread, and plastic sheet were linearly associated with a reduction in neonatal deaths with each additional clean delivery practice used. Costs of such kits are low (US$0.44 in India, US$0.40 in Nepal, and US$0.27 in Bangladesh, although these costs may still be prohibitive for the poorest women), and given the impact of clean delivery kits and clean delivery practices in reducing neonatal practices, such strategies should be widely promoted by the international community. Additional Information Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001180. A recent PLoS Medicine study by Oestergaard et al. has the latest figures on neonatal mortality worldwide UNICEF has information about progress toward Millennium Development Goal 4 The United Nations Population Fund has more information about safe birth practices The EquiNam web site describes ongoing work on socioeconomic inequalities in newborn and maternal health in Asia and Africa by some of the study authors
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- 2012
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106. A prediction model for neonatal mortality in low- and middle-income countries
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Prasanta Tripathy, David van Klaveren, Sushmita Das, Kishwar Azad, Tanja A. J. Houweling, Anthony Costello, Melissa Neuman, Erik de Jonge, Jasper V Been, Dharma S Manandhar, Ewout W. Steyerberg, Public Health, and Pediatrics
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Male ,0301 basic medicine ,neonatal mortality ,Epidemiology ,0302 clinical medicine ,Risk Factors ,Infant Mortality ,Medicine ,prognostic model ,Prospective Studies ,030212 general & internal medicine ,2. Zero hunger ,Bangladesh ,education.field_of_study ,1. No poverty ,General Medicine ,Prognosis ,3. Good health ,Premature birth ,Population Surveillance ,Educational Status ,Female ,pregnancy ,delivery ,Risk assessment ,Asia ,Population ,India ,Risk Assessment ,demographic surveillance ,03 medical and health sciences ,Nepal ,SDG 3 - Good Health and Well-being ,Humans ,Advanced maternal age ,education ,Developing Countries ,Pregnancy ,business.industry ,Infant, Newborn ,Infant ,Models, Theoretical ,medicine.disease ,Confidence interval ,Infant mortality ,Neonatal and Child Mortality ,030104 developmental biology ,Socioeconomic Factors ,Multiple birth ,business ,Demography - Abstract
BACKGROUND: In poor settings, where many births and neonatal deaths occur at home, prediction models of neonatal mortality in the general population can aid public-health policy-making. No such models are available in the international literature. We developed and validated a prediction model for neonatal mortality in the general population in India, Nepal and Bangladesh. METHODS: Using data (49 632 live births, 1742 neonatal deaths) from rural and urban surveillance sites in South Asia, we developed regression models to predict the risk of neonatal death with characteristics known at (i) the start of pregnancy, (ii) start of delivery and (iii) 5 minutes post partum. We assessed the models' discriminative ability by the area under the receiver operating characteristic curve (AUC), using cross-validation between sites. RESULTS: At the start of pregnancy, predictive ability was moderate {AUC 0.59 [95% confidence interval (CI) 0.58-0.61]} and predictors of neonatal death were low maternal education and economic status, short birth interval, primigravida, and young and advanced maternal age. At the start of delivery, predictive ability was considerably better [AUC 0.73 (95% CI 0.70-0.76)] and prematurity and multiple pregnancy were strong predictors of death. At 5 minutes post partum, predictive ability was good [AUC: 0.85 (95% CI 0.80-0.89)]; very strong predictors were multiple birth, prematurity and a poor condition of the infant at 5 minutes. CONCLUSIONS: We developed good performing prediction models for neonatal mortality. Neonatal deaths are highly concentrated in a small group of high-risk infants, even in poor settings in South Asia. Risk assessment, as supported by our models, can be used as a basis for improving community- and facility-based newborn care and prevention strategies in poor settings.
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107. Women's groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis
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Bhim P Shrestha, Neena Shah More, Arri Coomarasamy, Christine MacArthur, Anni-Maria Pulkki-Brännström, Kishwar Azad, Prasanta Tripathy, Amie Wilson, Christina Pagel, Tanja A. J. Houweling, Joanna Morrison, David Osrin, Abdul Kuddus, Mikey Rosato, Nirmala Nair, Jolene Skordis-Worrall, Naomi Saville, Audrey Prost, Bejoy Nambiar, Nadine Seward, Anthony Costello, Andrew Copas, Charles Mwansambo, Edward Fottrell, Tambosi Phiri, Tim Colbourn, Sonia Lewycka, Dharma S Manandhar, and Public Health
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Gerontology ,medicine.medical_specialty ,Low resource ,Population ,Alternative medicine ,Psychological intervention ,Developing country ,Community-based participatory research ,Article ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Survivorship curve ,Infant Mortality ,Humans ,Medicine ,030212 general & internal medicine ,10. No inequality ,education ,education.field_of_study ,business.industry ,030503 health policy & services ,Community Participation ,1. No poverty ,Participatory learning ,General Medicine ,Odds ratio ,Stillbirth ,Infant mortality ,3. Good health ,Maternal Mortality ,Action (philosophy) ,Meta-analysis ,Female ,0305 other medical science ,business ,Demography - Abstract
Summary Background Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women's groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings. Methods We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women's groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women's group intervention and estimated its potential effect at scale in Countdown countries. Findings Seven trials (119 428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women's groups was associated with a 23% non-significant reduction in maternal mortality (odds ratio 0·77, 95% CI 0·48–1·23), a 20% reduction in neonatal mortality (0·80, 0·67–0·96), and a 7% non-significant reduction in stillbirths (0·93, 0·82–1·05), with high heterogeneity for maternal ( I 2 =64·0%, p=0·011) and neonatal results ( I 2 =73·2%, p=0·001). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0·019 and p=0·009, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 49% reduction in maternal mortality (0·51, 0·29–0·89) and a 33% reduction in neonatal mortality (0·67, 0·60–0·75). The intervention was cost effective by WHO standards and could save an estimated 283 000 newborn infants and 36 600 mothers per year if implemented in rural areas of 74 Countdown countries. Interpretation With the participation of at least a third of pregnant women and adequate population coverage, women's groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings. Funding Wellcome Trust, Ammalife, and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Birmingham and the Black Country programme.
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108. The effect of prenatal balanced energy and protein supplementation on gestational weight gain: An individual participant data meta-analysis in low- and middle-income countries.
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Dongqing Wang, Uttara Partap, Enju Liu, Janaína Calu Costa, Ilana R Cliffer, Molin Wang, Sudeer Kumar Nookala, Vishak Subramoney, Brittany Briggs, Imran Ahmed, Alemayehu Argaw, Shabina Ariff, Nita Bhandari, Ranadip Chowdhury, Daniel Erchick, Armando García-Guerra, Masoumah Ghaffarpour, Giles Hanley-Cook, Lieven Huybregts, Fyezah Jehan, Fatemeh Kaseb, Nancy F Krebs, Carl Lachat, Tsering Pema Lama, Dharma S Manandhar, Elizabeth M McClure, Sophie E Moore, Ameer Muhammad, Lynnette M Neufeld, Andrew M Prentice, Amado D Quezada-Sánchez, Dominique Roberfroid, Naomi M Saville, Yasir Shafiq, Bhim P Shrestha, Bakary Sonko, Sajid Soofi, Sunita Taneja, James M Tielsch, Laéticia Céline Toe, Naser Valaei, and Wafaie W Fawzi
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Medicine - Abstract
BackgroundUnderstanding the effects of balanced energy and protein (BEP) supplements on gestational weight gain (GWG) and how the effects differ depending on maternal characteristics and the nutritional composition of the supplements will inform the implementation of prenatal BEP interventions.Methods and findingsIndividual participant data from 11 randomized controlled trials of prenatal BEP supplements (N = 12,549, with 5,693 in the BEP arm and 6,856 in the comparison arm) in low- and middle-income countries were used. The primary outcomes included GWG adequacy (%) and the estimated total GWG at delivery as continuous outcomes, and severely inadequate (125% adequacy) as binary outcomes; all variables were calculated based on the Institute of Medicine recommendations. Linear and log-binomial models were used to estimate study-specific mean differences or risk ratios (RRs), respectively, with 95% confidence intervals (CIs) of the effects of prenatal BEP on the GWG outcomes. The study-specific estimates were pooled using meta-analyses. Subgroup analyses were conducted by individual characteristics. Subgroup analyses and meta-regression were conducted for study-level characteristics. Compared to the comparison group, prenatal BEP led to a 6% greater GWG percent adequacy (95% CI: 2.18, 9.56; p = 0.002), a 0.59 kg greater estimated total GWG at delivery (95% CI, 0.12, 1.05; p = 0.014), a 10% lower risk of severely inadequate GWG (RR: 0.90; 95% CI: 0.83, 0.99; p = 0.025), and a 7% lower risk of inadequate GWG (RR: 0.93; 95% CI: 0.89, 0.97; p = 0.001). The effects of prenatal BEP on GWG outcomes were stronger in studies with a targeted approach, where BEP supplements were provided to participants in the intervention arm under specific criteria such as low body mass index or low GWG, compared to studies with an untargeted approach, where BEP supplements were provided to all participants allocated to the intervention arm.ConclusionsPrenatal BEP supplements are effective in increasing GWG and reducing the risk of inadequate weight gain during pregnancy. BEP supplementation targeted toward pregnant women with undernutrition may be a promising approach to delivering the supplements.
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- 2025
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109. Care for perinatal illness in rural Nepal: a descriptive study with cross-sectional and qualitative components
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Suresh Tamang, Anthony Costello, David Osrin, Dharma S Manandhar, Natasha Mesko, Madan K. Manandhar, Hilary Standing, and Bhim P Shrestha
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medicine.medical_specialty ,education.field_of_study ,Traditional Birth Attendant ,business.industry ,Perinatal illness ,Public health ,Traditional Healer ,lcsh:Public aspects of medicine ,Population ,Public Health, Environmental and Occupational Health ,lcsh:RA1-1270 ,Safe Motherhood ,Focus group ,Prolonged labour ,Infant mortality ,health care seeking practices ,Health facility ,Nursing ,Nepal ,medicine ,Traditional birth attendant ,Rural area ,education ,business ,Research Article - Abstract
Background Maternal, perinatal and neonatal mortality rates remain high in rural areas of developing countries. Most deliveries take place at home and care-seeking behaviour is often delayed. We report on a combined quantitative and qualitative study of care seeking obstacles and practices relating to perinatal illness in rural Makwanpur district, Nepal, with particular emphasis on consultation strategies. Methods The analysis included a survey of 8798 women who reported a birth in the previous two years [of whom 3557 reported illness in their pregnancy], on 30 case studies of perinatal morbidity and mortality, and on 43 focus group discussions with mothers, other family members and health workers. Results Early pregnancy was often concealed, preparation for birth was minimal and trained attendance at birth was uncommon. Family members were favoured attendants, particularly mothers-in-law. The most common recalled maternal complications were prolonged labour, postpartum haemorrhage and retained placenta. Neonatal death, though less definable, was often associated with cessation of suckling and shortness of breath. Many home-based care practices for maternal and neonatal illness were described. Self-medication was common. There were delays in recognising and acting on danger signs, and in seeking care beyond the household, in which the cultural requirement for maternal seclusion, and the perceived expense of care, played a part. Of the 760 women who sought care at a government facility, 70% took more than 12 hours from the decision to seek help to actual consultation. Consultation was primarily with traditional healers, who were key actors in the ascription of causation. Use of the government primary health care system was limited: the most common source of allopathic care was the district hospital. Conclusions Major obstacles to seeking care were: a limited capacity to recognise danger signs; the need to watch and wait; and an overwhelming preference to treat illness within the community. Safer motherhood and newborn care programmes in rural communities, must address both community and health facility care to have an impact on morbidity and mortality. The roles of community actors such as mothers-in-law, husbands, local healers and pharmacies, and increased access to properly trained birth attendants need to be addressed if delays in reaching health facilities are to be shortened.
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110. How to reach every newborn: three key messages
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Prasanta Tripathy, Anthony Costello, Kishwar Azad, Dharma S Manandhar, Tanja A. J. Houweling, Glyn Alcock, Sushma Shende, Joanna Morrison, and Public Health
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Asia ,business.industry ,lcsh:Public aspects of medicine ,Child Health Services ,Program activities ,Infant, Newborn ,lcsh:RA1-1270 ,General Medicine ,Public relations ,Computer security ,computer.software_genre ,Child health services ,Health Services Accessibility ,Health services ,Poverty Areas ,Key (cryptography) ,Medicine ,Humans ,Maternal Health Services ,Healthcare Disparities ,business ,computer - Full Text
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111. Impact on birth weight and child growth of Participatory Learning and Action women's groups with and without transfers of food or cash during pregnancy: Findings of the low birth weight South Asia cluster-randomised controlled trial (LBWSAT) in Nepal.
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Naomi M Saville, Bhim P Shrestha, Sarah Style, Helen Harris-Fry, B James Beard, Aman Sen, Sonali Jha, Anjana Rai, Vikas Paudel, Raghbendra Sah, Puskar Paudel, Andrew Copas, Bishnu Bhandari, Rishi Neupane, Joanna Morrison, Lu Gram, Anni-Maria Pulkki-Brännström, Jolene Skordis-Worrall, Machhindra Basnet, Saskia de Pee, Andrew Hall, Jayne Harthan, Meelan Thondoo, Sonja Klingberg, Janice Messick, Dharma S Manandhar, David Osrin, and Anthony Costello
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Medicine ,Science - Abstract
Undernutrition during pregnancy leads to low birthweight, poor growth and inter-generational undernutrition. We did a non-blinded cluster-randomised controlled trial in the plains districts of Dhanusha and Mahottari, Nepal to assess the impact on birthweight and weight-for-age z-scores among children aged 0-16 months of community-based participatory learning and action (PLA) women's groups, with and without food or cash transfers to pregnant women.We randomly allocated 20 clusters per arm to four arms (average population/cluster = 6150). All consenting married women aged 10-49 years, who had not had tubal ligation and whose husbands had not had vasectomy, were monitored for missed menses. Between 29 Dec 2013 and 28 Feb 2015 we recruited 25,092 pregnant women to surveillance and interventions: PLA alone (n = 5626); PLA plus food (10 kg/month of fortified wheat-soya 'Super Cereal', n = 6884); PLA plus cash (NPR750≈US$7.5/month, n = 7272); control (existing government programmes, n = 5310). 539 PLA groups discussed and implemented strategies to improve low birthweight, nutrition in pregnancy and hand washing. Primary outcomes were birthweight within 72 hours of delivery and weight-for-age z-scores at endline (age 0-16 months). Only children born to permanent residents between 4 June 2014 and 20 June 2015 were eligible for intention to treat analyses (n = 10936), while in-migrating women and children born before interventions had been running for 16 weeks were excluded. Trial status: completed.In PLA plus food/cash arms, 94-97% of pregnant women attended groups and received a mean of four transfers over their pregnancies. In the PLA only arm, 49% of pregnant women attended groups. Due to unrest, the response rate for birthweight was low at 22% (n = 2087), but response rate for endline nutritional and dietary measures exceeded 83% (n = 9242). Compared to the control arm (n = 464), mean birthweight was significantly higher in the PLA plus food arm by 78·0 g (95% CI 13·9, 142·0; n = 626) and not significantly higher in PLA only and PLA plus cash arms by 28·9 g (95% CI -37·7, 95·4; n = 488) and 50·5 g (95% CI -15·0, 116·1; n = 509) respectively. Mean weight-for-age z-scores of children aged 0-16 months (average age 9 months) sampled cross-sectionally at endpoint, were not significantly different from those in the control arm (n = 2091). Differences in weight for-age z-score were as follows: PLA only -0·026 (95% CI -0·117, 0·065; n = 2095); PLA plus cash -0·045 (95% CI -0·133, 0·044; n = 2545); PLA plus food -0·033 (95% CI -0·121, 0·056; n = 2507). Amongst many secondary outcomes tested, compared with control, more institutional deliveries (OR: 1.46 95% CI 1.03, 2.06; n = 2651) and less colostrum discarding (OR:0.71 95% CI 0.54, 0.93; n = 2548) were found in the PLA plus food arm but not in PLA alone or in PLA plus cash arms.Food supplements in pregnancy with PLA women's groups increased birthweight more than PLA plus cash or PLA alone but differences were not sustained. Nutrition interventions throughout the thousand-day period are recommended.ISRCTN75964374.
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- 2018
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112. The long-term impact of community mobilisation through participatory women's groups on women's agency in the household: A follow-up study to the Makwanpur trial.
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Lu Gram, Jolene Skordis-Worrall, Dharma S Manandhar, Daniel Strachan, Joanna Morrison, Naomi Saville, David Osrin, Kirti M Tumbahangphe, Anthony Costello, and Michelle Heys
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Medicine ,Science - Abstract
Women's groups practicing participatory learning and action (PLA) in rural areas have been shown to improve maternal and newborn survival in low-income countries, but the pathways from intervention to impact remain unclear. We assessed the long-term impact of a PLA intervention in rural Nepal on women's agency in the household. In 2014, we conducted a follow-up study to a cluster randomised controlled trial on the impact of PLA women's groups from 2001-2003. Agency was measured using the Relative Autonomy Index (RAI) and its subdomains. Multi-level regression analyses were performed adjusting for baseline socio-demographic characteristics. We additionally adjusted for potential exposure to subsequent PLA groups based on women's pregnancy status and conduct of PLA groups in areas of residence. Sensitivity analyses were performed using two alternative measures of agency. We analysed outcomes for 4030 mothers (66% of the cohort) who survived and were recruited to follow-up at mean age 39.6 years. Across a wide range of model specifications, we found no association between exposure to the original PLA intervention with women's agency in the household approximately 11.5 years later. Subsequent exposure to PLA groups was not associated with greater agency in the household at follow-up, but some specifications found evidence for reduced agency. Household agency may be a prerequisite for actualising the benefits of PLA groups rather than a consequence.
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- 2018
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113. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia
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David Osrin, Kishwar Azad, Armida Fernandez, Dharma S Manandhar, Charles W Mwansambo, Prasanta Tripathy, and Anthony M Costello
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Public aspects of medicine ,RA1-1270 - Abstract
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
- Published
- 2009
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