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Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

This study has been completed.
Stony Brook University
Information provided by:
University of Oklahoma Identifier:
First received: January 2, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 2, 2007
January 2, 2007
August 2002
Not Provided
  • Respiratory distress syndrome
  • Intraventricular hemorrhage
  • Neonatal mortality
Same as current
No Changes Posted
  • Periventricular leukomalacia
  • Necrotizing enterocolitis
  • Neonatal sepsis
Same as current
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Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"
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Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.
We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1, 2002 through July 31, 2004. We excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment. Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers. The statistical analysis was performed in accordance of the intention-to-treat principle. Student t test, Chi square and Fisher exact test were used for analysis. A P value of < .05 was considered statistically significant.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Respiratory Distress Syndrome
  • Intraventricular Hemorrhage
  • Neonatal Mortality
Drug: Betamethasone(Celestone soluspan) and Dexamethasone
Not Provided
Elimian A, Garry D, Figueroa R, Spitzer A, Wiencek V, Quirk JG. Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):26-30.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2005
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Inclusion Criteria:

  • Women in preterm labor with intact membranes
  • Women with preterm premature rupture of membranes
  • Women been delivered for fetal and maternal indications
  • Gestational age between 24 and 33 6/7 weeks’.

Exclusion Criteria:

  • Clinical chorioamnionitis
  • known major fetal structural anomalies,
  • known fetal chromosomal abnormalities,
  • prior antenatal steroid exposure,
  • quadruplets and higher order multiple gestation
  • Women who declined enrollment.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Oklahoma
Stony Brook University
Principal Investigator: Andrew A Elimian, M.D Stony Brook University
University of Oklahoma
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP