A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial
Creators: name: Pasha, Omrana
name: McClure, Elizabeth
name: Wright, Linda
name: Saleem, Sarah
name: Goudar, Shivaprasad
name: Chomba, Elwyn
name: Patel, Archana
name: Esamai, Fabian
name: Garces, Ana
name: Althabe, Fernando
name: Kodkany, Bhala
name: Mabeya, Hillary
name: Manasyan, Albert
name: Carlo, Waldemar
name: Derman, Richard
name: Hibberd, Patricia
name: Liechty, Edward
name: Krebs, Nancy
name: Hambidge, K
name: Buekens, Pierre
name: Moore, Janet
name: Jobe, Alan
name: Koso-Thomas, Marion
name: Wallace, Dennis
name: Stalls, Suzanne
name: Goldenberg, Robert L.
Publisher: name: Columbia University
Year: 2013
Subjects: Poor--Health and hygiene
Stillbirth
Obstetrical emergencies
Mothers--Mortality
Neonatal emergencies
Pregnancy--Complications
Newborn infants--Mortality
Obstetrics
Gynecology
Medicine
Public health

description: 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. Trial registration: ClinicalTrials.gov NCT01073488