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Recruiting NCT06723392

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

Phase III Interventional Preterm Birth Small for Gestational Age (SGA) Stillbirth Bacteriuria (Asymptomatic) in Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral nitrofurantoin monohydrate/macrocrystals, Placebo.
Who it may be relevant to
Registry conditions: Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Oral nitrofurantoin monohydrate/macrocrystals
    7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
  • Other Placebo
    7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Primary outcome measures

  • Number of small vulnerable newborn (SVN) or stillbirth (SB) [Time frame: From Pregnancy until 42 days postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

India · 2 centers
  • KLE Academy of Higher Education and Research — Belagavi
  • Lata Medical Research Foundation — Nagpur
Bangladesh · 1 center
  • Icddr,B — Dhaka
Democratic Republic of the Congo · 1 center
  • Kinshasa School of Public Health — Kinshasa
Guatemala · 1 center
  • Institue for Nutrition of Central America and Panama (INCAP) — Guatemala City
Pakistan · 1 center
  • Aga Khan University — Karachi
Zambia · 1 center
  • University Teaching Hospital — Lusaka

Identifiers

NCT: NCT06723392 · CP ABLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗