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1.  Is essential newborn care provided by institutions and after home births? Analysis of prospective data from community trials in rural South Asia 
Background
Provision of essential newborn care (ENC) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery. Understanding gaps in current coverage and where coverage is good, in different contexts and places of delivery, could make a valuable contribution to the future design of interventions to reduce neonatal mortality. We sought to describe the coverage of essential newborn care practices for births in institutions, at home with a skilled birth attendant, and at home without a skilled birth attendant (SBA) in rural areas of Bangladesh, Nepal, and India.
Methods
We used data from the control arms of four cluster randomised controlled trials in Bangladesh, Eastern India and from Makwanpur and Dhanusha districts in Nepal, covering periods from 2001 to 2011. We used these data to identify essential newborn care practices as defined by the World Health Organization. Each birth was allocated to one of three delivery types: home birth without an SBA, home birth with an SBA, or institutional delivery. For each study, we calculated the observed proportion of births that received each care practice by delivery type with 95% confidence intervals, adjusted for clustering and, where appropriate, stratification.
Results
After exclusions, we analysed data for 8939 births from Eastern India, 27 553 births from Bangladesh, 6765 births from Makwanpur and 15 344 births from Dhanusha. Across all study areas, coverage of essential newborn care practices was highest in institutional deliveries, and lowest in home non-SBA deliveries. However, institutional deliveries did not provide universal coverage of the recommended practices, with relatively low coverage (20%-70%) across all study areas for immediate breastfeeding and thermal care. Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care. Across all areas, fewer than 20% of home non-SBA deliveries used a clean delivery kit, the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor. There were large differences between study areas in handwashing, immediate breastfeeding and delayed bathing.
Conclusions
There remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding. For unattended home deliveries, increased handwashing, use of clean delivery kits and basic thermal care offer great scope for improvement.
doi:10.1186/1471-2393-14-99
PMCID: PMC4016384  PMID: 24606612
2.  Understanding psychological distress among mothers in rural Nepal: a qualitative grounded theory exploration 
BMC Psychiatry  2014;14:60.
Background
There is a large burden of psychological distress in low and middle-income countries, and culturally relevant interventions must be developed to address it. This requires an understanding of how distress is experienced. We conducted a qualitative grounded theory study to understand how mothers experience and manage distress in Dhanusha, a low-resource setting in rural Nepal. We also explored how distressed mothers interact with their families and the wider community.
Methods
Participants were identified during a cluster-randomised controlled trial in which mothers were screened for psychological distress using the 12-item General Health Questionnaire (GHQ-12). We conducted 22 semi-structured interviews with distressed mothers (GHQ-12 score ≥5) and one with a traditional healer (dhami), as well as 12 focus group discussions with community members. Data were analysed using grounded theory methods and a model was developed to explain psychological distress in this setting.
Results
We found that distress was termed tension by participants and mainly described in terms of physical symptoms. Key perceived causes of distress were poor health, lack of sons, and fertility problems. Tension developed in a context of limited autonomy for women and perceived duty towards the family. Distressed mothers discussed several strategies to alleviate tension, including seeking treatment for perceived physical health problems and tension from doctors or dhamis, having repeated pregnancies until a son was delivered, manipulating social circumstances in the household, and deciding to accept their fate. Their ability to implement these strategies depended on whether they were able to negotiate with their in-laws or husbands for resources.
Conclusions
Vulnerability, as a consequence of gender and social disadvantage, manifests as psychological distress among mothers in Dhanusha. Screening tools incorporating physical symptoms of tension should be envisaged, along with interventions to address gender inequity, support marital relationships, and improve access to perinatal healthcare.
doi:10.1186/1471-244X-14-60
PMCID: PMC3943437  PMID: 24581309
Nepal; South Asia; Psychological distress; Postnatal depression; Perinatal common mental disorders; Maternal mental health; Rural health
3.  Predictors of psychological distress among postnatal mothers in rural Nepal: A cross-sectional community-based study☆ 
Journal of Affective Disorders  2014;156(100):76-86.
Background
Perinatal common mental disorders are a major cause of disability among women and have consequences for children's growth and development. We aimed to identify factors associated with psychological distress, a proxy for common mental disorders, among mothers in rural Dhanusha, Nepal.
Methods
We used data from 9078 mothers who were screened for distress using the 12-item General Health Questionnaire (GHQ-12) around six weeks after delivery. We assessed the association between GHQ-12 score and socioeconomic, gender-based, cultural and reproductive health factors using a hierarchical analytical framework and multilevel linear regression models.
Results
Using a threshold GHQ-12 score of ≥6 to indicate caseness, the prevalence of distress was 9.8% (886/9078). Factors that predicted distress were severe food insecurity (β 2.21 (95% confidence interval 1.43, 3.40)), having a multiple birth (2.28 (1.27, 4.10)), caesarean section (1.70 (0.29, 2.24)), perinatal health problems (1.58 (1.23, 2.02)), no schooling (1.37 (1.08, 1.73)), fewer assets (1.33 (1.10, 1.60)), five or more children (1.33 (1.09, 1.61)), poor or no antenatal care (1.31 (1.15, 1.48) p<0.001), having never had a son (1.31 (1.14, 1.49)), not staying in the parental home in the postnatal period (1.15 (1.02, 1.30)), having a husband with no schooling (1.17 (0.96, 1.43)) and lower maternal age (0.99 (0.97, 1.00)).
Limitations
The study was cross-sectional and we were therefore unable to infer causality. Because data were not collected for some established predictors, including infant death, domestic violence and history of mental illness, we could not assess their associations with distress.
Conclusions
Socioeconomic disadvantage, gender inequality and poor reproductive health predict distress among mothers in Dhanusha. Maternal and child health programmes, as well as poverty-alleviation and educational interventions, may be beneficial for maternal mental health.
doi:10.1016/j.jad.2013.11.018
PMCID: PMC3969296  PMID: 24370265
Postnatal psychological distress; Postnatal depression; Common mental disorder; Nepal; Maternal mental health; Rural health
4.  Maternal infection and risk of intrapartum death: a population based observational study in South Asia 
Background
Approximately 1.2 million stillbirths occur in the intrapartum period, and a further 717,000 annual neonatal deaths are caused by intrapartum events, most of which occur in resource poor settings. We aim to test the ‘double-hit’ hypothesis that maternal infection in the perinatal period predisposes to neurodevelopmental sequelae from an intrapartum asphyxia insult, increasing the likelihood of an early neonatal death compared with asphyxia alone. This is an observational study of singleton newborn infants with signs of intrapartum asphyxia that uses data from three previously conducted cluster randomized controlled trials taking place in rural Bangladesh and India.
Methods
From a population of 81,778 births in 54 community clusters in rural Bangladesh and India, we applied mixed effects logistic regression to data on 3890 singleton infants who had signs of intrapartum asphyxia, of whom 769 (20%) died in the early neonatal period. Poor infant condition at five minutes post-delivery was our proxy measure of intrapartum asphyxia. We had data for two markers of maternal infection: fever up to three days prior to labour, and prolonged rupture of membranes (PROM). Cause-specific verbal autopsy data were used to validate our findings using previously mentioned mixed effect logistic regression methods and the outcome of a neonatal death due to intrapartum asphyxia.
Results
Signs of maternal infection as indicated by PROM, combined with intrapartum asphyxia, increased the risk of an early neonatal death relative to intrapartum asphyxia alone (adjusted odds ratio (AOR) 1.28, 95% CI 1.03 – 1.59). Results from cause-specific verbal autopsy data verified our findings where there was a significantly increased odds of a early neonatal death due to intrapartum asphyxia in newborns exposed to both PROM and intrapartum asphyxia (AOR: 1.52, 95% CI 1.15 – 2.02).
Conclusions
Our data support the double-hit hypothesis for signs of maternal infection as indicated by PROM. Interventions for pregnant women with signs of infection, to prevent early neonatal deaths and disability due to asphyxia, should be investigated further in resource-poor populations where the chances of maternal infection are high.
doi:10.1186/1471-2393-13-245
PMCID: PMC3897987  PMID: 24373126
Maternal infection; Double hit hypothesis; Intrapartum-related neonatal death; Prolonged rupture of membranes; Neonatal mortality; Low-income countries; Resource-poor
5.  Psychosocial Interventions for Perinatal Common Mental Disorders Delivered by Providers Who Are Not Mental Health Specialists in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(10):e1001541.
In a systematic review and meta-analysis, Kelly Clarke and colleagues examine the effect of psychosocial interventions delivered by non–mental health specialists for perinatal common mental disorders in low- and middle-income countries.
Please see later in the article for the Editors' Summary
Background
Perinatal common mental disorders (PCMDs) are a major cause of disability among women. Psychosocial interventions are one approach to reduce the burden of PCMDs. Working with care providers who are not mental health specialists, in the community or in antenatal health care facilities, can expand access to these interventions in low-resource settings. We assessed effects of such interventions compared to usual perinatal care, as well as effects of interventions based on intervention type, delivery method, and timing.
Methods and Findings
We conducted a systematic review, meta-analysis, and meta-regression. We searched databases including Embase and the Global Health Library (up to 7 July 2013) for randomized and non-randomized trials of psychosocial interventions delivered by non-specialist mental health care providers in community settings and antenatal health care facilities in low- and middle-income countries. We pooled outcomes from ten trials for 18,738 participants. Interventions led to an overall reduction in PCMDs compared to usual care when using continuous data for PCMD symptomatology (effect size [ES] −0.34; 95% CI −0.53, −0.16) and binary categorizations for presence or absence of PCMDs (odds ratio 0.59; 95% CI 0.26, 0.92). We found a significantly larger ES for psychological interventions (three studies; ES −0.46; 95% CI −0.58, −0.33) than for health promotion interventions (seven studies; ES −0.15; 95% CI −0.27, −0.02). Both individual (five studies; ES −0.18; 95% CI −0.34, −0.01) and group (three studies; ES −0.48; 95% CI −0.85, −0.11) interventions were effective compared to usual care, though delivery method was not associated with ES (meta-regression β coefficient −0.11; 95% CI −0.36, 0.14). Combined group and individual interventions (based on two studies) had no benefit compared to usual care, nor did interventions restricted to pregnancy (three studies). Intervention timing was not associated with ES (β 0.16; 95% CI −0.16, 0.49). The small number of trials and heterogeneity of interventions limit our findings.
Conclusions
Psychosocial interventions delivered by non-specialists are beneficial for PCMDs, especially psychological interventions. Research is needed on interventions in low-income countries, treatment versus preventive approaches, and cost-effectiveness.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Perinatal common mental health disorders are among the most common health problems in pregnancy and the postpartum period. In low- and middle-income countries, about 16% of women during pregnancy and about 20% of women in the postpartum period will suffer from a perinatal common mental health disorder. These disorders, including depression and anxiety, are a major cause of disability in women and have been linked to young children under their care being underweight and stunted.
Why Was This Study Done?
While research shows that both pharmacological (e.g., antidepressants or anti-anxiety medications) and non-pharmacological (e.g., psychotherapy, education, or health promotion) interventions are effective for preventing and treating perinatal common mental disorders, most of this research took place in high-income countries. These findings may not be applicable in low-resource settings, where there is limited access to mental health care providers such as psychiatrists and psychologists, and to medications. Thus, non-pharmacological interventions delivered by providers who are not mental health specialists may be important as ways to treat perinatal common mental health disorders in these types of settings. In this study the researchers systematically reviewed research estimating the effectiveness of non-pharmacological interventions for perinatal common mental disorders that were delivered by providers who were not mental health specialists (including health workers, lay persons, and doctors or midwives) in low- and middle-income countries. The researchers also used meta-analysis and meta-regression—statistical methods that are used to combine the results from multiple studies—to estimate the relative effects of these interventions on mental health symptoms.
What Did the Researchers Do and Find?
The researchers searched multiple databases using key search terms to identify randomized and non-randomized clinical trials. Using specific criteria, the researchers retrieved and assessed 37 full papers, of which 11 met the criteria for their systematic review. Seven of these studies were from upper middle-income countries (China, South Africa, Columbia, Mexico, Argentina, Cuba, and Brazil), and four trials were from the lower middle-income countries of Pakistan and India, but there were no trials from low-income countries. The researchers assessed the quality of the selected studies, and one study was excluded from meta-analysis because of poor quality.
Combining results from the ten remaining studies, the researchers found that compared to usual perinatal care (which in most cases included no mental health care), interventions delivered by a providers who were not mental health specialists were associated with an overall reduction in mental health symptoms and the likelihood of being diagnosed with a mental health disorder. The researchers then performed additional analyses to assess relative effects by intervention type, timing, and delivery mode. They observed that both psychological interventions, such as psychotherapy and cognitive behavioral therapy, and health promotion interventions that were less focused on mental health led to significant improvement in mental health symptoms, but psychological interventions were associated with greater effects than health promotion interventions. Interventions delivered both during pregnancy and postnatally were associated with significant benefits when compared to usual care; however, when interventions were delivered during pregnancy only, the benefits were not significantly greater than usual care. When investigating mode of delivery, the researchers observed that both group and individual interventions were associated with improvements in symptoms.
What Do These Findings Mean?
These findings indicate that non-pharmacological interventions delivered by providers who are not mental health specialists could be useful for reducing symptoms of perinatal mental health disorders in middle-income countries. However, these findings should be interpreted with caution given that they are based on a small number of studies with a large amount of variation in the study designs, settings, timing, personnel, duration, and whether the intervention was delivered to a group, individually, or both. Furthermore, when the researchers excluded studies of the lowest quality, the observed benefits of these interventions were smaller, indicating that this analysis may overestimate the true effect of interventions. Nevertheless, the findings do provide support for the use of non-pharmacological interventions, delivered by non-specialists, for perinatal mental health disorders. Further studies should be undertaken in low-income countries.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001541
The World Health Organization provides information about perinatal mental health disorders
The UK Royal College of Psychiatrists has information for professionals and patients about perinatal mental health disorders
doi:10.1371/journal.pmed.1001541
PMCID: PMC3812075  PMID: 24204215
6.  Women’s groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis 
Lancet  2013;381(9879):1736-1746.
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 37% reduction in maternal mortality (odds ratio 0·63, 95% CI 0·32–0·94), a 23% reduction in neonatal mortality (0·77, 0·65–0·90), and a 9% non-significant reduction in stillbirths (0·91, 0·79–1·03), with high heterogeneity for maternal (I2=58·8%, p=0·024) and neonatal results (I2=64·7%, p=0·009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0·026 and p=0·011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0·45, 0·17–0·73) and a 33% reduction in neonatal mortality (0·67, 0·59–0·74). The intervention was cost effective by WHO standards and could save an estimated 283 000 newborn infants and 41 100 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.
doi:10.1016/S0140-6736(13)60685-6
PMCID: PMC3797417  PMID: 23683640
7.  Identifying priorities to improve maternal and child nutrition among the Khmu ethnic group, Laos: a formative study 
Maternal & child nutrition  2012;9(4):452-466.
Chronic malnutrition in children remains highly prevalent in Laos, particularly among ethnic minority groups. There is limited knowledge of specific nutrition practices among these groups. We explored nutritional status, cultural beliefs and practices of Laos’ Khmu ethnic group to inform interventions for undernutrition as part of a Primary Health Care (PHC) project. Mixed methods were used. For background, we disaggregated anthropometric and behavioural indicators from Laos’ Multiple Indicator Cluster Survey. We then conducted eight focus group discussions and 33 semi-structured interviews with Khmu villagers and health care workers, exploring beliefs and practices related to nutrition.The setting was two rural districts in Luang Prabang province, in one of which the PHC project had been established for 3 years. There was a higher prevalence of stunting in the Khmu than in other groups. Disaggregation showed nutrition behaviours were associated with ethnicity, including exclusive breastfeeding. Villagers described strong adherence to post-partum food restrictions for women, while little change was described in intake during pregnancy. Most children were breastfed, although early introduction of pre-lacteal foods was noted in the non-PHC district. There was widespread variation in introduction and diversity of complementary foods. Guidance came predominantly from the community, with some input from health care workers. Interventions to address undernutrition in Khmu communities should deliver clear, consistent messages on optimum nutrition behaviours. Emphasis should be placed on dietary diversity for pregnant and post-partum mothers, encouraging exclusive breastfeeding and timely, appropriate complementary feeding. The impact of wider governmental policies on food security needs to be further assessed.
doi:10.1111/j.1740-8709.2012.00406.x
PMCID: PMC3496764  PMID: 22515273
beliefs; child feeding; community based; education; Laos; Khmu; maternal nutrition
8.  Taking ethical photos of children for medical and research purposes in low-resource settings: an exploratory qualitative study 
BMC Medical Ethics  2013;14:27.
Background
Photographs are commonly taken of children in medical and research contexts. With the increased availability of photographs through the internet, it is increasingly important to consider their potential for negative consequences and the nature of any consent obtained. In this research we explore the issues around photography in low-resource settings, in particular concentrating on the challenges in gaining informed consent.
Methods
Exploratory qualitative study using focus group discussions involving medical doctors and researchers who are currently working or have recently worked in low-resource settings with children.
Results
Photographs are a valuable resource but photographers need to be mindful of how they are taken and used. Informed consent is needed when taking photographs but there were a number of problems in doing this, such as different concepts of consent, language and literacy barriers and the ability to understand the information. There was no consensus as to the form that the consent should take. Participants thought that while written consent was preferable, the mode of consent should depend on the situation.
Conclusions
Photographs are a valuable but potentially harmful resource, thus informed consent is required but its form may vary by context. We suggest applying a hierarchy of dissemination to gauge how detailed the informed consent should be. Care should be taken not to cause harm, with the rights of the child being the paramount consideration.
doi:10.1186/1472-6939-14-27
PMCID: PMC3750443  PMID: 23835013
Photography; Ethics; Informed consent; Teleconference
9.  The equity impact of participatory women’s groups to reduce neonatal mortality in India: secondary analysis of a cluster-randomised trial 
Progress towards the Millennium Development Goals (MDGs) has been uneven. Inequalities in child health are large and effective interventions rarely reach the most in need. Little is known about how to reduce these inequalities. We describe and explain the equity impact of a women’s group intervention in India that strongly reduced the neonatal mortality rate (NMR) in a cluster-randomised trial. We conducted secondary analyses of the trial data, obtained through prospective surveillance of a population of 228 186. The intervention effects were estimated separately, through random effects logistic regression, for the most and less socio-economically marginalised groups. Among the most marginalised, the NMR was 59% lower in intervention than in control clusters in years 2 and 3 (70%, year 3); among the less marginalised, the NMR was 36% lower (35%, year 3). The intervention effect was stronger among the most than among the less marginalised (P-value for difference = 0.028, years 2-3; P-value for difference = 0.009, year 3). The stronger effect was concentrated in winter, particularly for early NMR. There was no effect on the use of health-care services in either group, and improvements in home care were comparable. Participatory community interventions can substantially reduce socio-economic inequalities in neonatal mortality and contribute to an equitable achievement of the unfinished MDG agenda.
doi:10.1093/ije/dyt012
PMCID: PMC3619953  PMID: 23509239
10.  Perinatal interventions and survival in resource-poor settings: which work, which don’t, which have the jury out? 
Archives of disease in childhood  2010;95(12):1039-1046.
Perinatal conditions make the largest contribution to the burden of disease in low-income countries. Although postneonatal mortality rates have declined, stillbirth and early neonatal mortality rates remain high in many countries in Africa and Asia, and there is a concentration of mortality around the time of birth. Our article begins by considering differences in the interpretation of ‘intervention’ to improve perinatal survival. We identify three types of intervention: a single action, a collection of actions delivered in a package and a broader social or system approach. We use this classification to summarise the findings of recent systematic reviews and meta-analyses. After describing the growing evidence base for the effectiveness of community-based perinatal care, we discuss current concerns about integration: of women’s and children’s health programmes, of community-based and institutional care, and of formal and informal sector human resources. We end with some thoughts on the complexity of choices confronting women and their families in low-income countries, particularly in view of the growth in non-government and private sector healthcare.
doi:10.1136/adc.2009.179366
PMCID: PMC3428881  PMID: 20980274
11.  The lives of Malawian Nurses: The stories behind the statistics 
Malawi faces a critical shortage of nurses. Challenging working conditions and poor remuneration have led many nurses to seek employment overseas. The study uses qualitative biographical methods to describe the experiences of migrant Malawian nurses and compares them with the experiences of nurses who remain in Malawi. Choices made about pursuing a nursing career in Malawi, and decisions to migrate, are complex and heavily entwined with nurses’ personal circumstances. In addition, although nurses in Malawi perceive that conditions in the UK are difficult, many still aspire to migrate themselves.
doi:10.1016/j.trstmh.2009.03.005
PMCID: PMC3428889  PMID: 19349055
International Migration; Human resources; Malawi; Nurses
12.  Predictors of maternal psychological distress in rural India: A cross-sectional community-based study 
Journal of Affective Disorders  2012;138(3):277-286.
Background
Maternal common mental disorders are prevalent in low-resource settings and have far-reaching consequences for maternal and child health. We assessed the prevalence and predictors of psychological distress as a proxy for common mental disorders among mothers in rural Jharkhand and Orissa, eastern India, where over 40% of the population live below the poverty line and access to reproductive and mental health services is low.
Method
We screened 5801 mothers around 6 weeks after delivery using the Kessler-10 item scale, and identified predictors of distress using multiple hierarchical logistic regression.
Results
11.5% (95% CI: 10.7–12.3) of mothers had symptoms of distress (K10 score > 15). High maternal age, low asset ownership, health problems in the antepartum, delivery or postpartum periods, caesarean section, an unwanted pregnancy for the mother, small perceived infant size and a stillbirth or neonatal death were all independently associated with an increased risk of distress. The loss of an infant or an unwanted pregnancy increased the risk of distress considerably (AORs: 7.06 95% CI: 5.51–9.04 and 1.49, 95% CI: 1.12–1.97, respectively).
Limitations
We did not collect data on antepartum depression, domestic violence or a mother's past birth history, and were therefore unable to examine the importance of these factors as predictors of psychological distress.
Conclusions
Mothers living in underserved areas of India who experience infant loss, an unwanted pregnancy, health problems in the perinatal and postpartum periods and socio-economic disadvantage are at increased risk of distress and require access to reproductive healthcare with integrated mental health interventions.
doi:10.1016/j.jad.2012.01.029
PMCID: PMC3343258  PMID: 22342117
Common mental disorder; Maternal depression; India; Rural health
13.  Association between Clean Delivery Kit Use, Clean Delivery Practices, and Neonatal Survival: Pooled Analysis of Data from Three Sites in South Asia 
PLoS Medicine  2012;9(2):e1001180.
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
doi:10.1371/journal.pmed.1001180
PMCID: PMC3289606  PMID: 22389634
14.  Scaling up community mobilisation through women's groups for maternal and neonatal health: experiences from rural Bangladesh 
Background
Program coverage is likely to be an important determinant of the effectiveness of community interventions to reduce neonatal mortality. Rigorous examination and documentation of methods to scale-up interventions and measure coverage are scarce, however. To address this knowledge gap, this paper describes the process and measurement of scaling-up coverage of a community mobilisation intervention for maternal, child and neonatal health in rural Bangladesh and critiques this real-life experience in relation to available literature on scaling-up.
Methods
Scale-up activities took place in nine unions in rural Bangladesh. Recruitment and training of those who deliver the intervention, communication and engagement with the community and other stakeholders and active dissemination of intervention activities are described. Process evaluation and population survey data are presented and used to measure coverage and the success of scale-up.
Results
The intervention was scaled-up from 162 women's groups to 810, representing a five-fold increase in population coverage. The proportion of women of reproductive age and pregnant women who were engaged in the intervention increased from 9% and 3%, respectively, to 23% and 29%.
Conclusions
Examination and documentation of how scaling-up was successfully initiated, led, managed and monitored in rural Bangladesh provide a deeper knowledge base and valuable lessons.
Strong operational capabilities and institutional knowledge of the implementing organisation were critical to the success of scale-up. It was possible to increase community engagement with the intervention without financial incentives and without an increase in managerial staff. Monitoring and feedback systems that allow for periodic programme corrections and continued innovation are central to successful scale-up and require programmatic and operational flexibility.
doi:10.1186/1471-2393-12-5
PMCID: PMC3298477  PMID: 22273440
15.  The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial 
Trials  2011;12:208.
Background
Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups.
Methods
A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected through interviews.
Trial registration
ISRCTN: ISRCTN01805825
doi:10.1186/1745-6215-12-208
PMCID: PMC3197496  PMID: 21943044
cluster randomised trial; neonatal mortality; community participation; Bangladesh; women's groups
16.  Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial 
Trials  2011;12:182.
Background
Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting.
The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa.
Methods/design
The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional endpoints include home care practices and health care-seeking in the antenatal, delivery and postnatal period. The impact of the intervention will be measured through a prospective surveillance system implemented by the project team, through which mothers will be interviewed around six weeks after delivery. Cost data and qualitative data are collected for cost-effectiveness and process evaluations.
Study registration
ISRCTN: ISRCTN31567106
doi:10.1186/1745-6215-12-182
PMCID: PMC3162534  PMID: 21787392
17.  Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications 
Trials  2011;12:151.
Background
Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations.
Methods
We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes.
Results
Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes.
Conclusions
The breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future community-based public health interventions around maternal and newborn health. Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest, the nature of the outcome of interest (mortality or behavioural) and the size and number of clusters. Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials.
doi:10.1186/1745-6215-12-151
PMCID: PMC3136407  PMID: 21672223
18.  Explaining the impact of a women's group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut trial process evaluation 
Background
Few large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008). The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries.
Methods
A participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees.
Results
Six broad, interrelated factors influenced the intervention's impact: (1) acceptability; (2) a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3) community involvement beyond the groups; (4) a focus on marginalized communities; (5) the active recruitment of newly pregnant women into groups; (6) high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial.
Conclusions
Participatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to local contexts. Scaling-up such interventions requires (1) a detailed understanding of the way in which context affects the acceptability and delivery of the intervention; (2) planned but flexible replication of key content and implementation features; (3) strong support for participatory methods from implementing agencies.
doi:10.1186/1472-698X-10-25
PMCID: PMC2987759  PMID: 20969787
19.  “There is such a thing as asking for trouble”: taking rapid HIV testing to gay venues is fraught with challenges 
Sexually Transmitted Infections  2007;83(3):185-188.
Objectives
To explore the feasibility and acceptability of offering rapid HIV testing to men who have sex with men in gay social venues.
Methods
Qualitative study with in‐depth interviews and focus group discussions. Interview transcripts were analysed for recurrent themes. 24 respondents participated in the study. Six gay venue owners, four gay service users and one service provider took part in in‐depth interviews. Focus groups were conducted with eight members of a rapid HIV testing clinic staff and five positive gay men.
Results
Respondents had strong concerns about confidentiality and privacy, and many felt that HIV testing was “too serious” an event to be undertaken in social venues. Many also voiced concerns about issues relating to post‐test support and behaviour, and clinical standards. Venue owners also discussed the potential negative impact of HIV testing on social venues.
Conclusion
There are currently substantial barriers to offering rapid HIV tests to men who have sex with men in social venues. Further work to enhance acceptability must consider ways of increasing the confidentiality and professionalism of testing services, designing appropriate pre‐discussion and post‐discussion protocols, evaluating different models of service delivery, and considering their cost‐effectiveness in relation to existing services.
doi:10.1136/sti.2006.023341
PMCID: PMC2659088  PMID: 17229791
20.  Improving Newborn Survival in Low-Income Countries: Community-Based Approaches and Lessons from South Asia 
PLoS Medicine  2010;7(4):e1000246.
David Osrin and colleagues discuss the critical importance of reducing global neonatal mortality in developing countries and how community-based approaches can help.
doi:10.1371/journal.pmed.1000246
PMCID: PMC2850383  PMID: 20386728
21.  Identifying priorities to improve maternal and child nutrition among the Khmu ethnic group, Laos: a formative study 
Maternal & Child Nutrition  2012;9(4):452-466.
Chronic malnutrition in children remains highly prevalent in Laos, particularly among ethnic minority groups. There is limited knowledge of specific nutrition practices among these groups. We explored nutritional status, cultural beliefs and practices of Laos' Khmu ethnic group to inform interventions for undernutrition as part of a Primary Health Care (PHC) project. Mixed methods were used. For background, we disaggregated anthropometric and behavioural indicators from Laos' Multiple Indicator Cluster Survey. We then conducted eight focus group discussions and 33 semi-structured interviews with Khmu villagers and health care workers, exploring beliefs and practices related to nutrition. The setting was two rural districts in Luang Prabang province, in one of which the PHC project had been established for 3 years. There was a higher prevalence of stunting in the Khmu than in other groups. Disaggregation showed nutrition behaviours were associated with ethnicity, including exclusive breastfeeding. Villagers described strong adherence to post-partum food restrictions for women, while little change was described in intake during pregnancy. Most children were breastfed, although early introduction of pre-lacteal foods was noted in the non-PHC district. There was widespread variation in introduction and diversity of complementary foods. Guidance came predominantly from the community, with some input from health care workers. Interventions to address undernutrition in Khmu communities should deliver clear, consistent messages on optimum nutrition behaviours. Emphasis should be placed on dietary diversity for pregnant and post-partum mothers, encouraging exclusive breastfeeding and timely, appropriate complementary feeding. The impact of wider governmental policies on food security needs to be further assessed.
doi:10.1111/j.1740-8709.2012.00406.x
PMCID: PMC3496764  PMID: 22515273
beliefs; child feeding; community based; education; Laos; Khmu; maternal nutrition

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