Abstract:
Introduction Maternal and neonatal infections are
among the most frequent causes of maternal and
neonatal mortality, and current antibiotic strategies have
been ineffective in preventing many of these deaths.
A randomised clinical trial conducted in a single site in
The Gambia showed that treatment with an oral dose
of 2 g azithromycin versus placebo for all women in
labour reduced certain maternal and neonatal infections.
However, it is unknown if this therapy reduces maternal
and neonatal sepsis and mortality. In a large, multinational
randomised trial, we will evaluate the impact of
azithromycin given in labour to improve maternal and
newborn outcomes.
Methods and analysis This randomised, placebo-
controlled, multicentre clinical trial includes two primary
hypotheses, one maternal and one neonatal. The maternal
hypothesis is to test whether a single, prophylactic
intrapartum oral dose of 2 g azithromycin given to women
in labour will reduce maternal death or sepsis. The
neonatal hypothesis will test whether this intervention
will reduce intrapartum/neonatal death or sepsis.
The intervention is a single, prophylactic intrapartum
oral dose of 2 g 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 will
be randomised with a one-to-one ratio to intervention/
placebo. In addition, we will assess antimicrobial
resistance in a sample of women and their newborns.
Ethics and dissemination The study protocol has
been reviewed and ethics approval obtained from all the
relevant ethical review boards at each research site. The results will be disseminated via peer-reviewed journals and national and
international scientific forums.
