Published online February 1, 2007
PEDIATRICS Vol. 119 No. 2 February 2007, pp. 290-298 (doi:10.1542/peds.2006-1549)

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ARTICLE

Randomized Trial of a Single Repeat Dose of Prenatal Betamethasone Treatment in Imminent Preterm Birth

Outi M. Peltoniemi, MD^a, M. Anneli Kari, MD, PhD^b, Outi Tammela, MD, PhD^c, Liisa Lehtonen, MD, PhD^d, Riitta Marttila, MD, PhD^e, Erja Halmesmäki, MD, PhD^f, Pentti Jouppila, MD, PhD^g, Mikko Hallman, MD, PhD^a for the Repeat Antenatal Betamethasone Study Group

^a Departments of Pediatrics
^g Obstetrics and Gynecology, University of Oulu, Oulu, Finland
^b Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland
^c Department of Pediatrics, University of Tampere, Tampere, Finland
^d Department of Pediatrics, University of Turku, Turku, Finland
^e Department of Pediatrics, Seinäjoki Central Hospital, Seinäjoki, Finland
^f Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland

BACKGROUND. A single dose of prenatal betamethasone treatment decreases neonatal morbidity rates when administered within 7 days before preterm delivery. A single repeat dose or booster dose of betamethasone before delivery has been proposed to be effective, but its efficacy has not been subjected to a randomized, blinded trial.

METHODS. Women with imminent delivery before 34.0 gestational weeks were eligible if they remained without delivery for >7 days after a single course of betamethasone. After stratification, a single repeat dose of betamethasone (12 mg) or placebo was administered. The primary outcome was survival without respiratory distress syndrome or severe intraventricular hemorrhage (grade 3 or 4).

RESULTS. A total of 249 mothers had been enrolled by the time the study was discontinued. All of the 159 infants in the betamethasone group and 167 in the placebo group were born before 36 weeks of gestation. The intact survival rate was unaffected and was lower than anticipated, because the gestational age-adjusted incidence of respiratory distress syndrome was higher than the population incidence. The requirement for surfactant therapy in respiratory distress syndrome was increased in the betamethasone group. According to posthoc analysis of the data for 206 infants who were delivered within 1 to 24 hours, the betamethasone booster tended to increase the risk of respiratory distress syndrome and to decrease intact survival rates.

CONCLUSIONS. According to this study, a single booster dose of betamethasone just before preterm birth may perturb respiratory adaptation. These results caution against uncontrolled use of a repeat dose of glucocorticoid in high-risk pregnancies.

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Key Words: prenatal corticosteroid • prenatal glucocorticoid • respiratory distress syndrome • premature infant • premature birth • intraventricular hemorrhage

Abbreviations: RDS—respiratory distress syndrome • IVH—intraventricular hemorrhage • CI—confidence interval • OR—odds ratio

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Accepted Oct 13, 2006.

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