Clinical trial NCT00418353: Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Intraventricular Hemorrhage
Neonatal Mortality
Keywords: Antenatal corticosteroids
Betamethasone
Dexamethasone
Premature
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Stony Brook University
First posted: 2007-01-04
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory distress syndrome
measure: Intraventricular hemorrhage
measure: Neonatal mortality
Secondary outcomes:
measure: Periventricular leukomalacia
measure: Necrotizing enterocolitis
measure: Neonatal sepsis
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Andrew A Elimian, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.AOG.0000268281.36788.81.