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Antenatal Betamethasone Compared to Dexamethasone - BETACODE TRIAL

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00418353
Enrollment
Unknown
Registered
2007-01-04
Start date
2002-08-31
Completion date
2005-04-30
Last updated
2007-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraventricular Hemorrhage, Neonatal Mortality, Respiratory Distress Syndrome

Keywords

Antenatal corticosteroids, Betamethasone, Dexamethasone, Premature

Brief summary

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.

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.

Interventions

DRUGBetamethasone(Celestone soluspan) and Dexamethasone

Sponsors

Stony Brook University
CollaboratorOTHER
University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
Respiratory distress syndrome
Intraventricular hemorrhage
Neonatal mortality

Secondary

MeasureTime frame
Periventricular leukomalacia
Necrotizing enterocolitis
Neonatal sepsis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026