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

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).

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Key information

Conditions

Preterm Birth Bacteriuria Bacteriuria (Asymptomatic) in Pregnancy Death Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Death Infections Male Urogenital Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Small For Gestational Age (SGA) Stillbirth Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Icddr,B, Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals who meet the following criteria are eligible for randomization:

Enrolled in GN MNHR
Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and/or clinical assessment and/or ultrasonography
Age: 18 years (or lower limit age eligible*) to 49 years

Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.
Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
Able to provide informed consent
Presence of a single bacterial isolate (>105 colony forming unit (CFU)/mL) in urine at enrollment
Intent to remain in study area for at least 42 days PP

Exclusion criteria

Individuals who meet any of the following criteria are not eligible for randomization:

Gestational age <12 weeks or >20 weeks
Received treatment with any antibiotic within 14 days before screening visit
Current symptoms of UTI
History of allergy to nitrofurantoin
Pregnancy loss / miscarriage prior to randomization
Currently taking magnesium-containing antacid
Any illness / condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment
Enrollment in another trial that per the study MOP will impact this trial

Treatment and study plan

Oral nitrofurantoin monohydrate/macrocrystals

Drug

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

Placebo

Other

7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Primary outcomes

Number of small vulnerable newborn (SVN) or stillbirth (SB)

Time frame: From Pregnancy until 42 days postpartum
SVN/SB, defined by the occurrence of any of the following:
- PTB, defined by birth <37 completed weeks gestation;
- SGA, defined by birth weight <10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards; or
- SB, defined by fetal loss or SB > 22 weeks' gestation.

Sponsors and collaborators

Lead sponsor

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

Network

Collaborators

Aga Khan University
Boston University
Columbia University
Institute of Nutrition of Central America and Panama
International Centre for Diarrhoeal Disease Research, Bangladesh
KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
Kinshasa School of Public Health
Lata Medical Research Foundation, Nagpur
RTI International
Thomas Jefferson University
University Teaching Hospital, Lusaka, Zambia
University of Alabama at Birmingham
University of Colorado, Denver
University of North Carolina, Chapel Hill
University of Virginia

Registry information

Official study 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

Acronym: ABLE

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Dec 9, 2024
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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