TY - JOUR
T1 - Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries
T2 - Study protocol
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.
AU - Bergel, Eduardo F.
AU - Jobe, Alan H.
AU - Buekens, Pierre
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84866289338&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84866289338&partnerID=8YFLogxK
U2 - 10.1186/1742-4755-9-22
DO - 10.1186/1742-4755-9-22
M3 - Article
C2 - 22992312
AN - SCOPUS:84866289338
SN - 1742-4755
VL - 9
JO - Reproductive Health
JF - Reproductive Health
IS - 1
M1 - 22
ER -