Actively Recruiting
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Led by NICHD Global Network for Women's and Children's Health · Updated on 2026-01-22
1134
Participants Needed
7
Research Sites
151 weeks
Total Duration
On this page
Sponsors
N
NICHD Global Network for Women's and Children's Health
Lead Sponsor
R
RTI International
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in Global Network Maternal Newborn Health Registry
- Pregnant with gestational age between 12 and 20 weeks by last menstrual period, clinical assessment, or ultrasound
- Age between 18 and 49 years (some sites may include emancipated minors or adults younger than 18 per local rules)
- Understand study procedures and willing to complete screening, randomization, study drug, and follow-up
- Able to provide informed consent
- Presence of a single bacterial isolate with more than 105 colony forming units per milliliter in urine at enrollment
- Intent to remain in study area for at least 42 days postpartum
You will not qualify if you...
- Gestational age less than 12 weeks or greater than 20 weeks
- Treated with any antibiotic within 14 days before screening
- Current symptoms of urinary tract infection
- Allergy to nitrofurantoin
- Pregnancy loss or miscarriage prior to randomization
- Currently taking magnesium-containing antacid
- Any illness or condition requiring immediate medical care as assessed by site investigator
- Enrolled in another trial that may impact this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Icddr,B
Dhaka, Bangladesh, Bangladesh
Actively Recruiting
2
Kinshasa School of Public Health
Kinshasa, DRC, Democratic Republic of the Congo
Not Yet Recruiting
3
Institue for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, Guatemala
Not Yet Recruiting
4
KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
Actively Recruiting
5
Lata Medical Research Foundation
Nagpur, Maharashtra, India
Not Yet Recruiting
6
Aga Khan University
Karachi, Pakistan, Pakistan
Not Yet Recruiting
7
University Teaching Hospital
Lusaka, Zambia, Zambia
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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