Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (NCT06723392) | Clinical Trial Compass
RecruitingPhase 3
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Bangladesh, Democratic Republic of the Congo, Guatemala1,134 participantsStarted 2025-12-08
Plain-language 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).
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of small vulnerable newborn (SVN) or stillbirth (SB)
Timeframe: From Pregnancy until 42 days postpartum
Trial details
NCT IDNCT06723392
SponsorNICHD Global Network for Women's and Children's Health