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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol
Reproductive Health, Volume 9, No. 1, Article 22, Year 2012
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Description
Background: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. Methods. We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. Trial registration. ClinicalTrials.gov. Identifier: NCT01084096. © 2012 Althabe et al.; licensee BioMed Central Ltd.
Authors & Co-Authors
Althabe, Fernando A.
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Belizán, J.
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Mazzoni, Agustina
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Berrueta, Mabel B.
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Hemingway-Foday, Jennifer J.
United States, Research Triangle Park
Rti International
Koso-Thomas, Marion W.
United States, Bethesda
National Institutes of Health Nih
McClure, Elizabeth M.
United States, Research Triangle Park
Rti International
Chomba, Elwyn Nachanya
Zambia, Lusaka
University Teaching Hospital Lusaka
Garcés, Ana Lucía
Guatemala, Guatemala City
Imsalud
Goudar, Shivaprasad S.
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Kodkany, Bhalachandra S.
India, Belgaum
Jawaharlal Nehru Medical College Belgaum
Saleem, Sarah
Pakistan, Karachi
The Aga Khan University Medical College
Pasha, Omrana
Pakistan, Karachi
The Aga Khan University Medical College
Patel, Archana Behram
India, Nagpur
Government Medical College Nagpur
Esamai, Fabian O.
Kenya, Eldoret
Moi University
Carlo, Waldemar A.
United States, Birmingham
The University of Alabama at Birmingham
Krebs, Nancy F.
United States, Aurora
University of Colorado Anschutz Medical Campus
Derman, Richard J.
United States, Wilmington
Christiana Care Health System
Goldenberg, Robert L.
United States, New York
Columbia University
Hibberd, Patricia L.
United States, Boston
Massachusetts General Hospital
Liechty, Edward A.
United States, Indianapolis
Indiana University School of Medicine
Wright, Linda L.
United States, Bethesda
National Institute of Child Health and Human Development Nichd
Bergel, Eduardo F.
Argentina, Buenos Aires
Institute for Clinical Effectiveness and Health Policy, Ciudad Autonoma de Buenos Aires
Jobe, Alan Hall
United States, Cincinnati
Cincinnati Children's Hospital Medical Center
Buekens, Pierre M.
United States, New Orleans
Tulane University School of Public Health and Tropical Medicine
Statistics
Citations: 40
Authors: 25
Affiliations: 18
Identifiers
Doi:
10.1186/1742-4755-9-22
e-ISSN:
17424755
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Study Approach
Quantitative
Study Locations
Kenya
Zambia
Participants Gender
Female