Treating asymptomatic urinary infection during pregnancy in low- and middle-income countries
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 trial will test whether giving pregnant people with asymptomatic bacteriuria nitrofurantoin (versus placebo) can reduce preterm birth, small-for-gestational-age babies, or stillbirth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1134 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | NICHD Global Network for Women's and Children's Health Research network |
| Locations | 7 sites (Dhaka, Bangladesh and 6 other locations) |
| Trial ID | NCT06723392 on ClinicalTrials.gov |
What this trial studies
This is a two-arm, phase 3 randomized controlled trial enrolling about 1,134 pregnant individuals across seven international sites to compare oral nitrofurantoin monohydrate/macrocrystals with placebo for asymptomatic bacteriuria detected between 12 and 20 weeks' gestation. Participants must have a single bacterial isolate at ≥10^5 CFU/mL and be enrolled in the GN MNHR; they are randomized to receive active drug or placebo and followed through delivery and at least 42 days postpartum to capture neonatal outcomes. Primary outcomes include rates of preterm birth, small-for-gestational-age infants, and stillbirth, with safety monitoring for maternal and neonatal adverse events. The trial aims to determine whether antibiotic treatment of asymptomatic bacteriuria in these low- and middle-income settings reduces newborn morbidity and mortality.
Who should consider this trial
Good fit: Pregnant individuals aged approximately 18–49 (with local exceptions) with a singleton pregnancy between 12 and 20 weeks, enrolled in the GN MNHR, who have a single urinary bacterial isolate ≥10^5 CFU/mL and can provide informed consent and remain in the study area through 42 days postpartum are ideal candidates.
Not a fit: People without asymptomatic bacteriuria, those with symptomatic urinary tract infection requiring immediate treatment, those with multiple or resistant bacterial isolates, or those with contraindications or allergy to nitrofurantoin are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, treating asymptomatic bacteriuria in pregnancy could lower rates of preterm birth, small-for-gestational-age infants, and stillbirths, improving newborn survival in participating communities.
How similar studies have performed: Previous research supports that treating asymptomatic bacteriuria reduces maternal urinary infections and may lower some adverse birth outcomes, but large randomized phase 3 trials in low- and middle-income settings are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dhaka, Bangladesh and 6 other locations
- Icddr,B — Dhaka, Bangladesh, Bangladesh (Recruiting)
- Kinshasa School of Public Health — Kinshasa, Drc, Democratic Republic of the Congo (Not_yet_recruiting)
- Institue for Nutrition of Central America and Panama (INCAP) — Guatemala City, Departamento de Guatemala, Guatemala (Not_yet_recruiting)
- KLE Academy of Higher Education and Research — Belagavi, Karnataka, India (Recruiting)
- Lata Medical Research Foundation — Nagpur, Maharashtra, India (Not_yet_recruiting)
- Aga Khan University — Karachi, Pakistan, Pakistan (Not_yet_recruiting)
- University Teaching Hospital — Lusaka, Zambia, Zambia (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.