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RECRUITING
NCT06723392
PHASE3

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

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

View on ClinicalTrials.gov

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

Interventions

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)

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