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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NICHD Global Network for Women's and Children's Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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