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Background: Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel.Methods/design: This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all participating centres. This, along with the inventory of resources and the satisfaction surveys administered to the health personnel, will allow us to measure results before, during, and after the intervention. The overall rate of maternal mortality measured in hospitals during the post-intervention period (Year 4) is the primary outcome. The evaluation will also include cost-effectiveness. [ABSTRACT FROM AUTHOR]