CSV Maternal Dataset in Prevention of maternal and neonatal death/infections with a single oral dose of azithromycin in women in labor (in low- and middle-income countries): A randomized controlled trial

Dataset with one record per mother randomized into the APLUS trial; variables related to maternal characteristics and outcomes
Study Description
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.The trial included two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. The maternal hypothesis was to test whether a single, prophylactic intrapartum oral dose of 2g azithromycin given to women in labour will reduce maternal death or sepsis. The neonatal hypothesis was to test whether this intervention will reduce intrapartum/neonatal death or sepsis. The intervention was a single, prophylactic intrapartum oral dose of 2g azithromycin, compared with a single intrapartum oral dose of an identical appearing placebo. A total of 34,000 labouring women from 8 research sites in sub-Saharan Africa, South Asia and Latin America were randomised with a one-to-one ratio to intervention/placebo. A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%). Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. Combined maternal and neonatal characteristics from 7 low-resource countries and 8 sites (Democratic Republic of Congo, Kenya, Zambia, Bangladesh, Guatemala, Nagpur, India, Belagavi, India, and Pakistan).

本数据集每条记录对应一名随机入组APLUS试验的产妇，涵盖产妇特征与妊娠结局相关变量。
试验描述：
产妇与新生儿感染是导致产妇及新生儿死亡的最常见诱因之一，当前的抗生素防控策略尚未能有效预防其中多数死亡病例。本试验包含两项核心假说：其一为产妇假说，旨在验证对临产产妇单次给予产时预防性口服2g阿奇霉素，是否可降低产妇死亡或脓毒症的发生风险；其二为新生儿假说，旨在验证该干预措施是否可降低产时/新生儿死亡或脓毒症的发生风险。
试验干预方案为单次产时预防性口服2g阿奇霉素，对照组则给予单次口服外观一致的安慰剂。研究共从撒哈拉以南非洲、南亚及拉丁美洲的8个研究中心招募34000名临产产妇，以1:1的随机比例将其分配至干预组或安慰剂组；最终共有29278名产妇完成随机分组。
结果显示，阿奇霉素组产妇脓毒症或死亡的发生率低于安慰剂组（1.6% vs. 2.4%）。在计划阴道分娩的产妇亚组中，单次口服阿奇霉素可显著降低产妇脓毒症或死亡的风险，但对新生儿脓毒症或死亡的影响微乎其微。
本数据集整合了来自7个资源匮乏国家的8个研究中心的产妇与新生儿联合特征数据，涉及的研究中心及国家分别为：刚果民主共和国、肯尼亚、赞比亚、孟加拉国、危地马拉、印度那格浦尔、印度贝拉加维以及巴基斯坦。