RecruitingPhase 3NCT06723392

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


Sponsor

NICHD Global Network for Women's and Children's Health

Enrollment

1,134 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Oral nitrofurantoin monohydrate/macrocrystals and Placebo for people with bacteriuria (asymptomatic) in pregnancy, preterm birth, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include women aged 18 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral nitrofurantoin monohydrate/macrocrystals

7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06723392


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