A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial
1 Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan
2 Department of Social, Statistical and Environmental Sciences, Research Triangle Institute, Durham, NC, USA
3 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA
4 KLE University’s Jawaharlal Nehru Medical College, Belgaum, India
5 Department of Pediatrics, University Teaching Hospital, Lusaka, Zambia
6 Indira Gandhi Government Medical College, Nagpur, India
7 Moi University School of Medicine, Eldoret, Kenya
8 Francisco Marroquin University, Guatemala City, Guatemala
9 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina
10 Centre for Infectious Disease Research Zambia, Lusaka, Zambia
11 University of Alabama at Birmingham, Birmingham, AL, USA
12 Christiana Care Health Services, Newark, DE, USA
13 Massachusetts General Hospital for Children, Boston, MA, USA
14 Indiana University, Indianapolis, IN, USA
15 University of Colorado, Denver, CO, USA
16 School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA
17 Research Triangle Institute, Durham, NC, USA
18 University of Cincinnati, Cincinnati, OH, USA
19 American College of Nurse Midwives, Washington, DC, USA
20 Department of Obstetrics and Gynecology, Columbia University, New York, NY, USA
BMC Medicine 2013, 11:215 doi:10.1186/1741-7015-11-215Published: 3 October 2013
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.
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.
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.
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.