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

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.

Condition Intervention
Respiratory Distress Syndrome
Intraventricular Hemorrhage
Neonatal Mortality
Drug: Betamethasone(Celestone soluspan) and Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Respiratory distress syndrome
  • Intraventricular hemorrhage
  • Neonatal mortality

Secondary Outcome Measures:
  • Periventricular leukomalacia
  • Necrotizing enterocolitis
  • Neonatal sepsis

Study Start Date: August 2002
Estimated Study Completion Date: April 2005
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00418353

United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 117913
Sponsors and Collaborators
University of Oklahoma
Stony Brook University
Principal Investigator: Andrew A Elimian, M.D Stony Brook University
  More Information

No publications provided by University of Oklahoma

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00418353     History of Changes
Other Study ID Numbers: 20024615
Study First Received: January 2, 2007
Last Updated: January 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Antenatal corticosteroids

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Respiratory System Agents processed this record on March 31, 2015