A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

Abstract

BackgroundThe UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action.Methods/DesignThis study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy.The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the women's group intervention, and exclusive breastfeeding rates and infant mortality for the infant feeding intervention.Structured interviews will be conducted with mothers one-month and six-months after birth to collect detailed quantitative data on care practices and health-care-seeking. Further qualitative, quantitative and economic data will be collected for process and economic evaluations.Trial registrationISRCTN06477126

Improving maternal and child healthcare programme using community-participatory interventions in Ebonyi State Nigeria

“…Emerging demand-driven approaches theoretically 'empower' communities to command services and provide a mechanism for (re)building trust and accountability and reestablishing the 'social contract' between communities and government (19). In conclusion we recommend the community-based participatory interventions to strengthen the FMCHCP, based on findings of the evaluation of impact of similar programmes showing the effectiveness of community-based participatory interventions (12)(13)(14)(15)(16)32). Several community mobilization interventions have used a participatory approach, building on the idea that if mothers and other community members take part in decision-making and bring local knowledge, experiences and problems to the fore, they are more likely to own and sustain solutions to improve their communities' health (32).…”

“…This is to be achieved by introducing the following packages which were proven as very effective in previous studies (20,21): i) Community-based birth preparedness package: It is a social mobilization programme to promote the behaviour of families to prepare for birth by engaging volunteers to counsel the mothers and families during home visits as well as during the community group meetings (12,16,17,(21)(22)(23). ii) Community-based newborn care package: The package consists of service delivery component, home visitation as well as community mobilisation to enhance skills on community case management of infection, home-based care of Low Birth Weight (LBW), and birth asphyxia as well as orientation to mothers' group, traditional healer and traditional birth attendant about the programme (12,13,(15)(16)(17)21,24). iii) Community-based infant and young child feeding package: is a package having counselling component on early breast feeding, exclusive breast feeding, extended breast feeding, complementary feeding and food diversification (16,20,25).…”

“…ii) Community-based newborn care package: The package consists of service delivery component, home visitation as well as community mobilisation to enhance skills on community case management of infection, home-based care of Low Birth Weight (LBW), and birth asphyxia as well as orientation to mothers' group, traditional healer and traditional birth attendant about the programme (12,13,(15)(16)(17)21,24). iii) Community-based infant and young child feeding package: is a package having counselling component on early breast feeding, exclusive breast feeding, extended breast feeding, complementary feeding and food diversification (16,20,25). iv) Community-based integrated management of childhood illness package: This is a package which has a service delivery component such as the delivery of commodities as well as community participation and the promotion of positive health behaviours and enhancement of skills for home-based management of pneumonia and diarrhoea as well as orientation to mothers about the programme in the community (16,20,22,23).…”

“…iii) Community-based infant and young child feeding package: is a package having counselling component on early breast feeding, exclusive breast feeding, extended breast feeding, complementary feeding and food diversification (16,20,25). iv) Community-based integrated management of childhood illness package: This is a package which has a service delivery component such as the delivery of commodities as well as community participation and the promotion of positive health behaviours and enhancement of skills for home-based management of pneumonia and diarrhoea as well as orientation to mothers about the programme in the community (16,20,22,23).…”

A Cluster Randomized Controlled Community Based Trial Utilizing a Continuum of care Among Pregnant Women: Outcomes in the Women

“…The appreciable change in mortality of pregnant women in resource challenged countries (5,7,9) is a good progress,but the proportion of neonatal deaths has increased in all regions of the world6. Sub-Saharan Africa carries the second largest burden of neonatal mortality in the world, against a backdrop of the high HIV/AIDS rates, civil unrest, extreme poverty and weak health systems.8 Underlying causes of death relate to the high number of deliveries that take place without skilled attendance due to geographic distance, together with lack of adequate transportation (5,7,9) .…”