Abstract:
Background: Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income
countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.
Methods: This trial tested the hypothesis that teams of health care providers, administrators and local residents can
address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal
mortality in intervention compared to control locations. In seven geographic areas in five low-income and one
middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we
performed a cluster randomized non-masked trial of a package of interventions that included community mobilization
focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and
facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal
mortality at ≥28 weeks gestation or birth weight ≥1000 g.
Results: Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the
primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal
mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in
the last six months of the project, in the year following intervention cessation, nor in the clusters that best
implemented the intervention.
Conclusions: This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable
impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that
achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal
care infrastructure than was available at the sites during this trial, and without them provider training and community
mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized
trials, as interventions that should be effective may not be.
