The goal of this three-year study is to recruit a total of 34,000 women and assess whether a single oral dose of the antibiotic azithromycin is effective in preventing sepsis and mortality in pregnant women and newborns during labor.

According to the World Health Organization, infection during pregnancy and shortly after birth causes approximately 10 percent of maternal deaths worldwide. Infections in newborns cause approximately 16 percent of newborn deaths worldwide. Current antibiotic treatment strategies have not proven to be effective in preventing these deaths. Researchers hope to show that azithromycin will prove to be a simple yet effective intervention.

Azithromycin is an antibiotic currently used to fight against a broad range of bacteria and other infections. Since it can be kept at room temperature, it is seen as a suitable option for countries where refrigeration is not always easily accessible or even possible. In a prior preliminary study, azithromycin was found to be effective in reducing both maternal and infant infections when administered at the beginning of labor.

The FNIH was awarded a grant by the Bill & Melinda Gates Foundation that will increase the initial Global Network cohort of 5,500 women with high-risk pregnancies to include 28,500 additional women with low-risk pregnancies. This addition increases the generalizability of the study findings significantly, which increases the utility of the study in helping to inform sound health care policy for women and children.

This study will be conducted at Global Network sites in low- and middle-income countries including Bangladesh, Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan and Zambia.

For more information about the project, click here.

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