Open Access Research article

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial

Omrana Pasha1*, Elizabeth M McClure2, Linda L Wright3, Sarah Saleem1, Shivaprasad S Goudar4, Elwyn Chomba5, Archana Patel6, Fabian Esamai7, Ana Garces8, Fernando Althabe9, Bhala Kodkany4, Hillary Mabeya7, Albert Manasyan10, Waldemar A Carlo11, Richard J Derman12, Patricia L Hibberd13, Edward K Liechty14, Nancy Krebs15, K Michael Hambidge15, Pierre Buekens16, Janet Moore17, Alan H Jobe18, Marion Koso-Thomas3, Dennis D Wallace17, Suzanne Stalls19, Robert L Goldenberg20 and On Behalf of the EMONC Trial Investigators

Author Affiliations

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

For all author emails, please log on.

BMC Medicine 2013, 11:215  doi:10.1186/1741-7015-11-215

Published: 3 October 2013

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.

Trial registration

ClinicalTrials.gov NCT01073488

Keywords:
Stillbirth; Neonatal mortality; Maternal mortality; Emergency obstetric care