Randomized Trial on Antibiotic Treatment of Asymptomatic Bacteriuria in Pregnant Women in Low- and Middle-Income Countries to Reduce Preterm Birth and Stillbirth

What this Trial Is About

Researchers are evaluating the effects of antibiotic treatment on asymptomatic bacteriuria AB during pregnancy in low- and middle-income countries. This phase 3 randomized controlled trial aims to reduce the incidence of small vulnerable newborns SVN and stillbirths SB, contributing to global health goals to prevent early childhood deaths. The study involves pregnant individuals and newborns across seven international sites collaborating with the NICHD Global Network for Womens and Childrens Health Research. Participants with AB are randomly assigned to one of two groups one group receives a 7-day course of oral nitrofurantoin monohydratemacrocrystals at 100 mg twice daily 14 doses total, while the other group receives a matching placebo on the same schedule. The study compares the impact of this antibiotic treatment versus placebo during pregnancy. During the study, participants will complete screening, randomization, treatment, and follow-up visits, with monitoring continuing until 42 days after birth. Researchers will assess the number of small vulnerable newborns or stillbirths as the main outcome. Participants must remain in the study area for the full postpartum follow-up period, during which health and safety are monitored carefully.

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries