FNIH Launches Project Testing Antibiotic to Prevent Infections in Mothers, Newborns

The Foundation for the National Institutes of Health (FNIH) has announced a new project to test whether an antibiotic taken during labor can prevent infections in mothers and newborns in seven countries. The UNC-Chapel Hill site leader is Carl Bose, MD.

 FNIH Launches Project Testing Antibiotic to Prevent Infections in Mothers, Newborns click to enlarge Carl Bose, MD

June 3, 2020

The Foundation for the National Institutes of Health (FNIH) has announced a new project that will test whether an antibiotic taken during labor can prevent infections in mothers and newborns in seven low- and middle-income countries. This study will be conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through their Global Network for Women’s and Children’s Health Research (Global Network) with funding from the Bill & Melinda Gates Foundation.

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.

The site leader at UNC-Chapel Hill is Carl Bose, MD, professor of pediatrics at the UNC School of Medicine and member of the UNC Institute for Global Health and Infectious Diseases.

He is leading a team working with the Kinshasa School of Public Health in the Democratic Republic of Congo.

“Because of the risk of death from infection, pregnancy and childbirth are frightening for women in developing countries," Bose said. "We are pleased to participate with our colleagues in the Democratic Republic of Congo, and around the world, in this very important study that promises to make a difference in the lives of these women and their newborns.”

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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