Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

"Competing interests: None declared."

"Funding: The study, and BN and TC, were wholly funded by The Health Foundation, London, UK. The project funders commissioned the randomized controlled trial to evaluate the two interventions, but had no direct input into the design of the study, data collection or data analysis. Their research director made site visits, provided valuable advice during implementation, and commented on the interpretation and write-up of the results and so is an author."

"The design of the trial is reported in full elsewhere. The trial was registered as an International Standard Randomised Controlled Trial [ISRCTN18073903]. A locally registered non-government organization (NGO), MaiKhanda (Chichewa for ‘mother and newborn infant’) was set up in Malawi to implement the interventions. Methods: We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods."