Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol

Fernando Althabe, José M. Belizán, Agustina Mazzoni, Mabel Berrueta, Jay Hemingway-Foday, Marion Koso-Thomas, Elizabeth McClure, Elwyn Chomba, Ana Garces, Shivaprasad Goudar, Bhalchandra Kodkany, Sarah Saleem, Omrana Pasha, Archana Patel, Fabian Esamai, Waldemar A. Carlo, Nancy F. Krebs, Richard J. Derman, Robert L. Goldenberg, Patricia HibberdEdward A. Liechty, Linda L. Wright, Eduardo F. Bergel, Alan H. Jobe, Pierre Buekens

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number22
JournalReproductive Health
Volume9
Issue number1
DOIs
StatePublished - 2012

Fingerprint

Premature Birth
Infant Mortality
Developing Countries
Adrenal Cortex Hormones
Survival
Premature Infants
Steroids
Health
Newborn Infant
Gestational Age
Guatemala
Zambia
High-Risk Pregnancy
Kenya
Pakistan
Argentina
Syringes
Low Birth Weight Infant
Standard of Care
Developed Countries

Keywords

  • Antenatal corticosteroids
  • Implementation research
  • Neonatal mortality
  • Preterm birth

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Althabe, F., Belizán, J. M., Mazzoni, A., Berrueta, M., Hemingway-Foday, J., Koso-Thomas, M., ... Buekens, P. (2012). Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol. Reproductive Health, 9(1), [22]. https://doi.org/10.1186/1742-4755-9-22

Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries : Study protocol. / Althabe, Fernando; Belizán, José M.; Mazzoni, Agustina; Berrueta, Mabel; Hemingway-Foday, Jay; Koso-Thomas, Marion; McClure, Elizabeth; Chomba, Elwyn; Garces, Ana; Goudar, Shivaprasad; Kodkany, Bhalchandra; Saleem, Sarah; Pasha, Omrana; Patel, Archana; Esamai, Fabian; Carlo, Waldemar A.; Krebs, Nancy F.; Derman, Richard J.; Goldenberg, Robert L.; Hibberd, Patricia; Liechty, Edward A.; Wright, Linda L.; Bergel, Eduardo F.; Jobe, Alan H.; Buekens, Pierre.

In: Reproductive Health, Vol. 9, No. 1, 22, 2012.

Research output: Contribution to journalArticle

Althabe, F, Belizán, JM, Mazzoni, A, Berrueta, M, Hemingway-Foday, J, Koso-Thomas, M, McClure, E, Chomba, E, Garces, A, Goudar, S, Kodkany, B, Saleem, S, Pasha, O, Patel, A, Esamai, F, Carlo, WA, Krebs, NF, Derman, RJ, Goldenberg, RL, Hibberd, P, Liechty, EA, Wright, LL, Bergel, EF, Jobe, AH & Buekens, P 2012, 'Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: Study protocol', Reproductive Health, vol. 9, no. 1, 22. https://doi.org/10.1186/1742-4755-9-22
Althabe, Fernando ; Belizán, José M. ; Mazzoni, Agustina ; Berrueta, Mabel ; Hemingway-Foday, Jay ; Koso-Thomas, Marion ; McClure, Elizabeth ; Chomba, Elwyn ; Garces, Ana ; Goudar, Shivaprasad ; Kodkany, Bhalchandra ; Saleem, Sarah ; Pasha, Omrana ; Patel, Archana ; Esamai, Fabian ; Carlo, Waldemar A. ; Krebs, Nancy F. ; Derman, Richard J. ; Goldenberg, Robert L. ; Hibberd, Patricia ; Liechty, Edward A. ; Wright, Linda L. ; Bergel, Eduardo F. ; Jobe, Alan H. ; Buekens, Pierre. / Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries : Study protocol. In: Reproductive Health. 2012 ; Vol. 9, No. 1.
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AU - Althabe, Fernando

AU - Belizán, José M.

AU - Mazzoni, Agustina

AU - Berrueta, Mabel

AU - Hemingway-Foday, Jay

AU - Koso-Thomas, Marion

AU - McClure, Elizabeth

AU - Chomba, Elwyn

AU - Garces, Ana

AU - Goudar, Shivaprasad

AU - Kodkany, Bhalchandra

AU - Saleem, Sarah

AU - Pasha, Omrana

AU - Patel, Archana

AU - Esamai, Fabian

AU - Carlo, Waldemar A.

AU - Krebs, Nancy F.

AU - Derman, Richard J.

AU - Goldenberg, Robert L.

AU - Hibberd, Patricia

AU - Liechty, Edward A.

AU - Wright, Linda L.

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AU - Jobe, Alan H.

AU - Buekens, Pierre

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