A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial
Fernando Althabe, Agustina Mazzoni, Marina Laski, Ariel karolinski, Mabel Berrueta
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.
Objective: Assess if a multi-feceted intervention based on traininig at different levels in obstetric and neonatal emergencies reduces fetal al neonatal mortality.
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.
Assess if a multi-feceted intervention based on traininig at different levels in obstetric and neonatal emergencies reduces fetal al neonatal mortality.
Red Global para la investigación en Salud de las Mujeres y los Niños.National Instituto of Child Health and Human Development (NICHD), Bethesda, MD
Pasha O, McClure EM, Wright LL, Saleem S, Goudar SS, Chomba E, Patel A, Esamai F, Garces A, Althabe F, Kodkany B, Mabeya H, Manasyan A, Carlo WA, Derman RJ, Hibberd PL, Liechty EK, Krebs N, Hambidge KM, Buekens P, Moore J, Jobe AH, Koso-Thomas M, Wallace DD, Stalls S, Goldenberg RL. A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial. BMC Med. 2013 Oct 3;11(1):215. [Full text] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853358/pdf/1741-7015-11-215.pdf
Omrana Pasha, Robert L Goldenberg, Elizabeth M McClure, Sarah Saleem, Shivaprasad S Goudar, Fernando Althabe, Archana Patel, Fabian Esamai, Ana Garces, Elwyn Chomba, Manolo Mazariegos, Bhala Kodkany, Jose M Belizan, Richard J Derman, Patricia L Hibberd, Waldemar A Carlo, Edward A Liechty, K Michael Hambidge, Pierre Buekens, Dennis Wallace, Lisa Howard-Grabman, Suzanne Stalls, Marion Koso-Thomas, Alan H Jobe, Linda L Wright. Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the global network’s EmONC trial). BMC Pregnancy Childbirth. 2010; 10: 82. Published online 2010 December 14. doi: 10.1186/1471-2393-10-82. [Full text] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3017016/pdf/1471-2393-10-82.pdf