Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Status:
NOT_YET_RECRUITING
Trial end date:
2028-11-01
Target enrollment:
Participant gender:
Summary
This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \[End preventable deaths of newborns and children under 5 years of age\] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).
Phase:
PHASE3
Details
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborators:
Aga Khan University Boston University Columbia University Institute of Nutrition of Central America and Panama International Centre for Diarrhoeal Disease Research, Bangladesh Kinshasa School of Public Health KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India Lata Medical Research Foundation, Nagpur RTI International Thomas Jefferson University University of Alabama at Birmingham University of Colorado, Denver University of North Carolina, Chapel Hill University of Virginia University Teaching Hospital, Lusaka, Zambia