Almost all (99%) of maternal, neonatal, infant and child deaths arise in low and middle income countries, yet most research is focused on the 1% of deaths that occur in high income countries. There is a need to identify feasible and cost-effective evidence-based interventions applicable in low income and middle income countries, as well as strategies for scaling-up these interventions. The Global Network for Women's and Children's Health Research (GN) is best suited to face that challenge. Our main specific aim is to develop and implement common protocols of randomized controlled trials (RCTs) sponsored by the GN. The consortium between Tulane University and the Institute for Clinical Effectiveness and Health Policy in Buenos Aires, Argentina, has extensive experience in conducting large, collaborative RCTs in Latin America and around the world, including a successful and productive participation in the GN first cycle. We have implemented one cluster RCT in 19 hospitals in six cities of Argentina and Uruguay, one cluster RCT in 16 communities in two provinces of Argentina, and one multicentric survey in 1,523 pregnant women in both countries. As an illustration of the protocols we are planning to develop, we are proposing a cluster RCT to test an intervention to increase the use of antenatal corticosteroids in developing countries to prevent neonatal deaths. The administration of antenatal corticosteroids to babies at high risk of preterm birth is the most powerful antenatal intervention to reduce neonatal mortality, reducing neonatal deaths between 25%- 50%. However, in low and middle income countries, only 10% of preterm babies are currently receiving this form of care. We propose to conduct a cluster RCT among 30 communities in 6-8 GN countries. The intervention will determine if we can increase the use of antenatal corticosteroids and reduce neonatal mortality and will consist of implementing the following strategies at all health care levels at intervention settings: 1) diffusing guidelines to healthcare providers;2) improving the identification of women needing corticosteroids by measuring uterine height with a color-coded tape to estimate gestational age in women with signs of labor;and 3) providing antenatal corticosteroids kits containing corticosteroids Uniject devices and instructions for administration. This research could have a large impact on neonatal mortality in low and middle income countries and is thus highly relevant to public health.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HD040477-10S1
Application #
8460990
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (25))
Program Officer
Koso-Thomas, Marion
Project Start
2001-08-17
Project End
2013-04-30
Budget Start
2011-05-01
Budget End
2013-04-30
Support Year
10
Fiscal Year
2012
Total Cost
$343,007
Indirect Cost
$34,516
Name
Tulane University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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Althabe, Fernando; Belizán, José M; McClure, Elizabeth M et al. (2015) A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial. Lancet 385:629-39
Goudar, Shivaprasad S; Stolka, Kristen B; Koso-Thomas, Marion et al. (2015) Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings. Reprod Health 12 Suppl 2:S2
Althabe, Fernando; Berrueta, Mabel; Hemingway-Foday, Jennifer et al. (2015) A color-coded tape for uterine height measurement: a tool to identify preterm pregnancies in low resource settings. PLoS One 10:e0117134

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