Antenatal betamethasone compared with dexamethasone (Betacode trial)

A randomized controlled trial

Andrew Elimian, David Garry, Reinaldo Figueroa, Alan Spitzer, Vandy Wiencek, J. Gerald Quirk

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

OBJECTIVE: To compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants. METHODS: We enrolled 299 women at risk for preterm delivery in a double-blind, placebo-controlled, randomized trial of antenatal betamethasone compared with dexamethasone at Stony Brook University Hospital from August 2002 through July 2004. We excluded women with clinical chorioamnionitis, fetal structural and chromosomal abnormalities, prior antenatal steroid exposure, and steroid use for other indications. Statistical analysis was performed in accordance of the intention-to-treat principle. RESULTS: There were no significant differences between the groups with regard to baseline characteristics. The rate of respiratory distress syndrome, need for vasopressor therapy, necrotizing enterocolitis, retinopathy of prematurity, patent ductus arteriosus, neonatal sepsis, and neonatal mortality were not significant different between the groups. However, the rates of intraventricular hemorrhage (6 of 105 [5.7%] compared with 17 of 100 [17.0%], relative risk [RR] 2.97, 95% confidence interval [CI] 1.22-7.24, P=.02) and any brain lesion (7 of 105 [6.7%] compared with 18 of 100 [18.0%], RR 2.7, 95% CI 1.18-6.19, P=.02) were significantly lower in neonates exposed to dexamethasone compared with betamethasone. The absolute risk reduction in the rate of intraventricular hemorrhage was 11.3 % ( 95% CI 2.7-11.9%), and the number needed to treat was 9 (95% CI 5-37) in favor of dexamethasone. CONCLUSION: Betamethasone and dexamethasone are comparable in reducing the rate of most major neonatal morbidities and mortality in preterm neonates. However, dexamethasone seems to be more effective in reducing the rate of intraventricular hemorrhage compared with betamethasone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00418353

Original languageEnglish (US)
Pages (from-to)26-30
Number of pages5
JournalObstetrics and Gynecology
Volume110
Issue number1
DOIs
StatePublished - Jul 2007
Externally publishedYes

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Betamethasone
Dexamethasone
Randomized Controlled Trials
Confidence Intervals
Numbers Needed To Treat
Infant Mortality
Hemorrhage
Steroids
Newborn Infant
Morbidity
Chorioamnionitis
Retinopathy of Prematurity
Necrotizing Enterocolitis
Patent Ductus Arteriosus
Perinatal Mortality
Respiratory Rate
Premature Infants
Chromosome Aberrations
Placebos
Clinical Trials

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Antenatal betamethasone compared with dexamethasone (Betacode trial) : A randomized controlled trial. / Elimian, Andrew; Garry, David; Figueroa, Reinaldo; Spitzer, Alan; Wiencek, Vandy; Quirk, J. Gerald.

In: Obstetrics and Gynecology, Vol. 110, No. 1, 07.2007, p. 26-30.

Research output: Contribution to journalArticle

Elimian, Andrew ; Garry, David ; Figueroa, Reinaldo ; Spitzer, Alan ; Wiencek, Vandy ; Quirk, J. Gerald. / Antenatal betamethasone compared with dexamethasone (Betacode trial) : A randomized controlled trial. In: Obstetrics and Gynecology. 2007 ; Vol. 110, No. 1. pp. 26-30.
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