Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial
Azithromycin in Labor Lowers Clinical Infections in Mothers and Newborns: A Double-Blind Trial
复制标题
DOI：
10.1542/peds.2016-2281
复制
发表时间：
2017-02-01
期刊：
影响因子：
8
通讯作者：
Roca, Anna
中科院分区：
文献类型：
--
作者：
Oluwalana, Claire;Camara, Bully;Roca, Anna
背景和目的：我们最近完成了一项概念验证试验，表明在分娩期间给予阿奇霉素后，妇女和新生儿的细菌定植减少。在这里，我们的目的是评估干预对孕产妇和新生儿临床infecties.METHODS的效果：这是一个双盲，安慰剂对照的随机试验。冈比亚妇女在劳动给予口服剂量的阿奇霉素（2克）或安慰剂。结果：从2013年4月至2014年4月，我们共招募了829名母亲及其830名新生儿。16名婴儿在随访期间死亡（每组8名）。未报告与干预措施相关的孕产妇死亡或严重不良事件。阿奇霉素组的母亲感染率较低（3.6% vs 9.2%;相对危险度[RR]，0.40; 95%置信区间[CI]，0.22-0.71; P = .002），乳腺炎患病率也是如此。（1.4% vs 5.1%; RR，0.29; 95% CI，0.12-0.70; P = 0.005）和发热（1.9% vs 5.8%; RR，0.33; 95% CI，0.15-0.74; P = 0.006）。在新生儿中，阿奇霉素组的总体感染率也较低（18.1% vs 23.8%; RR，0.76; 95%CI，0.58-0.99; P = 0.052），皮肤感染的患病率有显著差异（3.1%vs 6.4%; RR，0.49; 95%CI，0.25-0.93; P = 0.034）.结论：分娩期妇女给予阿奇霉素可减少产褥期妇女和新生儿的感染。更大规模的研究旨在评估干预措施对严重发病率和死亡率的影响是必要的。
BACKGROUND AND OBJECTIVES: We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections.METHODS: This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery.RESULTS: From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034).CONCLUSIONS: Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted.