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

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

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)

Sponsors & Collaborators

• RTI International

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Boston University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Kinshasa School of Public Health

  collaborator OTHER

• Institute of Nutrition of Central America and Panama

  collaborator OTHER

• Lata Medical Research Foundation, Nagpur

  collaborator OTHER

• Aga Khan University

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India

  collaborator UNKNOWN

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

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-08

Primary Completion

2028-09-30

Completion

2028-11-30

Countries

• Bangladesh
• Democratic Republic of the Congo
• Guatemala
• India
• Pakistan
• Zambia

Study Locations