Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE)

January 20, 2026 updated by: NICHD Global Network for Women's and Children's Health

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Bangladesh
      • Dhaka, Bangladesh, Bangladesh
        • Recruiting
        • Icddr,b
        • Principal Investigator:
          • Rashidul Haque, MD
        • Principal Investigator:
          • SK Masum Billah
        • Contact:
  • Democratic Republic of the Congo
    • DRC
      • Kinshasa, DRC, Democratic Republic of the Congo
        • Not yet recruiting
        • Kinshasa School of Public Health
        • Principal Investigator:
          • Antoinette Tshefu, MD, PhD, MPH
        • Contact:
  • Guatemala
    • Departamento de Guatemala
      • Guatemala City, Departamento de Guatemala, Guatemala
        • Not yet recruiting
        • Institue for Nutrition of Central America and Panama (INCAP)
        • Contact:
        • Principal Investigator:
          • Manolo Mazariegos, MD, MPH
  • India
    • Karnataka
      • Belagavi, Karnataka, India
        • Recruiting
        • KLE Academy of Higher Education and Research
        • Principal Investigator:
          • Shivaprasad S Goudar, MD, MHPE
        • Contact:
          • Shivaprasad S Goudar, MD, MHPE
          • Phone Number: 919448126371
          • Email: sgoudar@jnmc.edu
    • Maharashtra
      • Nagpur, Maharashtra, India
        • Not yet recruiting
        • Lata Medical Research Foundation
        • Contact:
        • Principal Investigator:
          • Archana Patel, MD, DNB, MSCE, PhD
  • Pakistan
    • Pakistan
      • Karachi, Pakistan, Pakistan
        • Not yet recruiting
        • Aga Khan University
        • Principal Investigator:
          • Sarah Saleem, MD
        • Contact:
  • Zambia
    • Zambia
      • Lusaka, Zambia, Zambia
        • Not yet recruiting
        • University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Elwyn Chomba, MBChB, DCH, MRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral nitrofurantoin monohydrate/macrocrystals
Pregnant individuals with AB randomized to receive a 7-day course of oral NM/M 100 mg twice daily (total of 14 doses)
Drug: Oral nitrofurantoin monohydrate/macrocrystals
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
Placebo Comparator: Placebo
Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Other: Placebo
7-day course of oral placebo 100 mg twice daily (total of 14 doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Pregnancy until 42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP ABLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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