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Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Sponsor: NICHD Global Network for Women's and Children's Health
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).
Official title: Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research
Key Details
Gender
FEMALE
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
1134
Start Date
2025-12-08
Completion Date
2028-11
Last Updated
2026-01-22
Healthy Volunteers
Yes
Conditions
Interventions
Oral nitrofurantoin monohydrate/macrocrystals
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
Placebo
7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Locations (7)
Icddr,B
Dhaka, Bangladesh, Bangladesh
Kinshasa School of Public Health
Kinshasa, DRC, Democratic Republic of the Congo
Institue for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, Guatemala
KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
Lata Medical Research Foundation
Nagpur, Maharashtra, India
Aga Khan University
Karachi, Pakistan, Pakistan
University Teaching Hospital
Lusaka, Zambia, Zambia