Document Detail


Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial.
MedLine Citation:
PMID:  17601892     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Andrew Elimian; David Garry; Reinaldo Figueroa; Alan Spitzer; Vandy Wiencek; J Gerald Quirk
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  110     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-02     Completed Date:  2007-07-31     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  26-30     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics, Gynecology and Reproductive Medicine, Stony Brook University, Stony Brook, New York, USA. andrew-elimian@ouhsc.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00418353
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MeSH Terms
Descriptor/Qualifier:
Adult
Betamethasone / therapeutic use*
Cerebral Hemorrhage / prevention & control*
Dexamethasone / therapeutic use*
Double-Blind Method
Female
Fetal Diseases / prevention & control
Humans
Infant, Newborn
Morbidity
Pregnancy
Premature Birth / drug therapy,  prevention & control*
Respiratory Distress Syndrome, Newborn / prevention & control
Tocolytic Agents / therapeutic use*
Chemical
Reg. No./Substance:
0/Tocolytic Agents; 378-44-9/Betamethasone; 50-02-2/Dexamethasone
Comments/Corrections
Comment In:
Obstet Gynecol. 2007 Oct;110(4):930; author reply 931   [PMID:  17906034 ]
Obstet Gynecol. 2007 Oct;110(4):930; author reply 931   [PMID:  17906035 ]
Obstet Gynecol. 2007 Jul;110(1):7-9   [PMID:  17601889 ]
Obstet Gynecol. 2007 Oct;110(4):930; author reply 931   [PMID:  17906036 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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