title: Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol.
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.
authors.affiliation: Institute for Clinical Effectiveness and Health Policy (IECS), Dr. Emilio Ravignani 2024, Buenos Aires, C1414CPV, Argentina.
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
authors.forename: José M
authors.initials: JM
authors.lastname: Belizán
authors.forename: Agustina
authors.initials: A
authors.lastname: Mazzoni
authors.forename: Mabel
authors.initials: M
authors.lastname: Berrueta
authors.forename: Jay
authors.initials: J
authors.lastname: Hemingway-Foday
authors.forename: Marion
authors.initials: M
authors.lastname: Koso-Thomas
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McClure
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Ana
authors.initials: A
authors.lastname: Garces
authors.forename: Shivaprasad
authors.initials: S
authors.lastname: Goudar
authors.forename: Bhalchandra
authors.initials: B
authors.lastname: Kodkany
authors.forename: Sarah
authors.initials: S
authors.lastname: Saleem
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Archana
authors.initials: A
authors.lastname: Patel
authors.forename: Fabian
authors.initials: F
authors.lastname: Esamai
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Krebs
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Derman
authors.forename: Robert L
authors.initials: RL
authors.lastname: Goldenberg
authors.forename: Patricia
authors.initials: P
authors.lastname: Hibberd
authors.forename: Edward A
authors.initials: EA
authors.lastname: Liechty
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.forename: Eduardo F
authors.initials: EF
authors.lastname: Bergel
authors.forename: Alan H
authors.initials: AH
authors.lastname: Jobe
authors.forename: Pierre
authors.initials: P
authors.lastname: Buekens
mesh_terms: D002985:Clinical Protocols; D003906:Developing Countries; D003907:Dexamethasone / Q000627:therapeutic use*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000517:prevention & control; D005865:Gestational Age; D006700:Home Childbirth / Q000009:adverse effects; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007752:Obstetric Labor, Premature / Q000188:drug therapy; D011247:Pregnancy; D047928:Premature Birth / Q000401:mortality / Q000517:prevention & control*; D011295:Prenatal Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
chemical_list: D003907:Dexamethasone