Abstract:
Background: Maternal and newborn mortality rates remain unacceptably high, especially where the majority of
births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric
and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes.
However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also
unproven is the effectiveness of community mobilization and community birth attendant training to improve
pregnancy outcomes.
Methods/Design: We have developed a cluster-randomized controlled trial to evaluate the impact of a
comprehensive intervention of community mobilization, birth attendant training and improvement of quality of
care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take
place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each)
across 7 sites of the Global Network for Women’s and Children’s Health Research in Argentina, Guatemala, India,
Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based
life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve
quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of
stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and
obstetrical sepsis) and 28-day neonatal mortality.
Discussion: In this trial, we are evaluating a combination of interventions including community mobilization and
facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide
important information for policy makers and clinicians as they attempt to improve delivery services for pregnant
women and newborns in low-income countries.
Trial Registration: ClinicalTrials.gov NCT01073488.
