TY - JOUR
T1 - A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings
T2 - A Global Network cluster randomized trial
AU - Pasha, Omrana
AU - McClure, Elizabeth M.
AU - Wright, Linda L.
AU - Saleem, Sarah
AU - Goudar, Shivaprasad S.
AU - Chomba, Elwyn
AU - Patel, Archana
AU - Esamai, Fabian
AU - Garces, Ana
AU - Althabe, Fernando
AU - Kodkany, Bhala
AU - Mabeya, Hillary
AU - Manasyan, Albert
AU - Carlo, Waldemar A.
AU - Derman, Richard J.
AU - Hibberd, Patricia L.
AU - Liechty, Edward K.
AU - Krebs, Nancy
AU - Hambidge, K. M.
AU - Buekens, Pierre
AU - Moore, Janet
AU - Jobe, Alan H.
AU - Koso-Thomas, Marion
AU - Wallace, Dennis D.
AU - Stalls, Suzanne
AU - Goldenberg, Robert L.
AU - Mazzoni, Agustina
AU - Laski, Marina
AU - Karolinski, Ariel
AU - Berrueta, Mabel
AU - Kaseba, Christine
AU - Morales, Evelyn
AU - Mahantshetti, N. S.
AU - Honnungar, N. V.
AU - Patil, Kamal
AU - Swamy, M. K.
AU - Ahsan, Sadiah
AU - Hussain, Khadim
AU - Ahsan, Azra
AU - Waikar, Manju
AU - Kulkarni, Nivedita
AU - Thakre, Sushama
AU - Bhatnagar, Manoj
AU - Rono, Betsy
AU - Gisore, Peter
AU - Mbeya, Hillary
N1 - Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/10/3
Y1 - 2013/10/3
N2 - 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.
AB - 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.
KW - Emergency obstetric care
KW - Maternal mortality
KW - Neonatal mortality
KW - Stillbirth
UR - http://www.scopus.com/inward/record.url?scp=84884873704&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84884873704&partnerID=8YFLogxK
U2 - 10.1186/1741-7015-11-215
DO - 10.1186/1741-7015-11-215
M3 - Article
C2 - 24090370
AN - SCOPUS:84884873704
VL - 11
JO - BMC Medicine
JF - BMC Medicine
SN - 1741-7015
IS - 1
M1 - 215
ER -