Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries

Launched by NICHD GLOBAL NETWORK FOR WOMEN'S AND CHILDREN'S HEALTH · Dec 4, 2024

Keywords

ClinConnect Summary

The Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-Income Countries (ABLE) trial is studying how treating a specific type of urinary infection, known as asymptomatic bacteriuria, might help improve pregnancy outcomes for mothers and their babies. The goal is to see if this treatment can help prevent serious issues like preterm birth, small babies at birth, and stillbirth. The study will involve about 1,134 pregnant women from various countries, who will be randomly assigned to either receive the antibiotic treatment or not, to see how it affects their health and the health of their babies.

To be part of this trial, women need to be between 18 and 49 years old, be in their pregnancy between 12 to 20 weeks, and have a specific type of bacteria present in their urine. They should also be willing to follow the study procedures and stay in the area for at least 42 days after giving birth. Participants can expect regular check-ups and support throughout the study. It’s important to note that the trial is not yet recruiting participants, but it aims to gather valuable information that could lead to better health for mothers and children in the future.

Gender

FEMALE

Eligibility 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