Dataset from Antenatal Late Preterm Steroids: A Randomized Placebo Controlled Trial

The Antenatal Late Preterm Steroids Trial (ALPS) was a randomized, multicenter, double-blind trial to determine whether antenatal corticosteroids given to women at high risk for late preterm birth (34 weeks to 36 weeks) reduces stillbirth or the need for neonatal respiratory support of preterm birth or neonatal death in the first 72 hours. Women with a singleton pregnancy at 34-36 weeks who were at high risk for preterm delivery were randomized to 2 injections of betamethasone or matching placebo 24 hours apart. There were 2831 women randomized; 4 were lost to follow-up. The primary outcome occurred in 165 infants (11.6%) in the betamethasone group and 202 (14.4%) in the placebo group (RR 0.80; 95% CI, 0.66-0.97; p=0.02). Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. Neonatal hypoglycemia was more common in the betamethasone group (p<0.001).

产前晚期早产类固醇试验（Antenatal Late Preterm Steroids Trial, ALPS）是一项随机、多中心、双盲临床试验，旨在评估对于存在晚期早产（孕34周至36周）高风险的孕妇，产前给予糖皮质激素是否可降低死胎发生率、早产儿出生后前72小时内需新生儿呼吸支持的比例，以及新生儿死亡率。本研究将孕34~36周、单胎妊娠且存在早产高风险的女性随机分为两组，分别接受两次倍他米松（betamethasone）注射或匹配的安慰剂注射，两次注射间隔24小时。本试验共纳入2831名完成随机分组的孕妇，其中4人失访。倍他米松组共有165名婴儿（11.6%）出现主要结局事件，安慰剂组为202名（14.4%）（相对风险RR=0.80；95%置信区间CI：0.66~0.97；p=0.02）。倍他米松组的严重呼吸道并发症、新生儿暂时性呼吸增快症（transient tachypnea of the newborn）、表面活性物质使用需求以及支气管肺发育不良（bronchopulmonary dysplasia）的发生率也显著更低。倍他米松组的新生儿低血糖发生率更高（p<0.001）。