Every year globally, more than two million babies die shortly after birth, while nearly 300,000 women die from preventable causes related to pregnancy and childbirth. Many of these deaths—about 10 percent of maternal mortality and about 16 percent of neonatal mortality—are caused by infection, and many occur in low- and middle-income countries. Despite the widespread availability of antibiotics, there has been little recent progress in reducing this toll.
In 2020, the FNIH announced the launch of a new initiative to advance research on a simple but innovative intervention that could be a game-changer for preventing maternal and newborn death. Launched in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development with funding from the Bill & Melinda Gates Foundation, the Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in Low- and Middle-Income Countries, also called the A-Plus study, will assess how well a single oral dose of azithromycin during labor can protect the health of both mothers and newborns.
Recent preliminary trials of providing azithromycin during labor in the U.S. and The Gambia have shown promising results, but a much larger study is needed to confirm these findings. The A-Plus trial will enroll 34,000 women across South Asia, sub-Saharan Africa and Central America. If the results of this large, three-year trial show that prophylactic treatment leads to fewer infections and deaths, it could initiate a transformation in practice at participating sites and new guidelines from the World Health Organization and other professional organizations, potentially saving the lives of mothers and babies around the world.