Preterm Birth Clinical Trial
Official title:
Trial of the Use of Antenatal Corticosteroids in Developing Countries
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.
One of the United Nations Millennium Summit goals is to reduce the deaths of children <5
years by two-thirds for 2015 (UN, 2000). Given that 38% of all under-five deaths worldwide
occur in the first four weeks of life, the goal seems unattainable unless a significant
fraction of the neonatal deaths are prevented (Darmstadt et al., 2005). Thus, the provision
of health care during the perinatal period in developing countries is a top priority. Preterm
birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths
overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman
et al., 2005) in middle and high income countries, it is expected that as low income
countries improve their development, the relative importance of this cause will increase. One
of the most powerful perinatal interventions to reduce neonatal mortality is the
administration of antenatal corticosteroids to pregnant women at high risk of preterm birth.
The primary objective will be to evaluate whether a cluster-level multifaceted intervention,
including components to improve the identification of pregnancies at high risk of preterm
birth and providing and facilitating the appropriate use of steroids, reduces neonatal
mortality at 28 days of life in preterm newborns, compared with the standard delivery of care
in selected populations of six African, Asian, and Latin American countries.
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