Treating asymptomatic urinary infection during pregnancy in low- and middle-income countries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Icddr,B
  Dhaka, Bangladesh, Bangladesh Recruiting
• KLE Academy of Higher Education and Research
  Belagavi, Karnataka, India 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
• Lata Medical Research Foundation
  Nagpur, Maharashtra, India Not yet recruiting
• Aga Khan University
  Karachi, Pakistan, Pakistan Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.