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Multicenter randomized trial of single versus weekly courses of antenatal corticosteroids



Multicenter randomized trial of single versus weekly courses of antenatal corticosteroids



American Journal of Obstetrics & Gynecology 184(1): S6



OBJECTIVES: To compare rates of composite neonatal morbidity in women receiving single (SC) versus weekly courses (WC) of ACS. STUDY DESIGN: After their first course of standard ACS therapy, women at risk for preterm delivery were randomly assigned to receive betamethasone (12 mg IM q24h X 2) or placebo injections weekly until 34 0/7 weeks. The primary outcome measure was the rate of composite neonatal morbidity (any of: severe RDS, BPD, severe IVH (grade III or IV), PVL, proven sepsis, NEC, neonatal death). The primary analysis was intent to treat. The first interim analysis was presented at SMFM in January 2000. RESULTS: From March 1996 to March 2000 a total of 502 women were enrolled; 16 were lost to follow-up leaving 236 assigned to SC and 250 to WC. At randomization and delivery the groups were well balanced for potential confounders. The composite morbidity rates were 23% WC vs 28% SC (unadjusted RR 0.84; 95% CI 0.62 to 1.13). There were no differences in composite morbidity rates when stratified by center, or by gestational age groups at randomization or delivery. On multivariable analysis, treatment assignment was not associated with a significant reduction in composite morbidity. There were no differences in rates of RDS (28% WC vs 29% SC, P = .78), BPD, NEC, or proven sepsis. Severe IVH was more common in the WC group (10 cases WC versus 2 cases SC; RR 3.8; 95% CI 0.8 to 17.5). CONCLUSION: Overall, weekly courses of ACS did not reduce either the composite morbidity rate or the RDS rate beyond the reduction achieved with SC therapy. Weekly courses should not be routinely prescribed for women at risk for preterm delivery.

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Accession: 035349917

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