NCT06723392

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,134 (estimated)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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).

Conditions

• Preterm Birth
• Small for Gestational Age (SGA)
• Stillbirth
• Bacteriuria (Asymptomatic) in Pregnancy

Interventions

Type	Name	Description
DRUG	Oral nitrofurantoin monohydrate/macrocrystals	7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
OTHER	Placebo	7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-09-01
• Completion: 2028-11-01
• First posted: 2024-12-09
• Last updated: 2026-01-22

Locations

7 sites across 6 countries: Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia