CSV Fetal and Neonatal 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 stillbirth and livebirth born to mothers randomized into the APLUS trial; variables related to fetal/neonatal 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).