Bacteriuria (Asymptomatic) in Pregnancy, Preterm Birth, Small for Gestational Age (SGA), Stillbirth
Conditions
Keywords
asymptomatic bacteriuria, small vulnerable newborn, preterm birth, small for gestational agea, still birth, SVN/SB, oral nitrofurantoin monohydrate/macrocrystals, Global Network, Bangladesh, India, Pakistan, Democratic Republic of Congo, Zambia, Guatemala
Brief 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).
Interventions
DRUGOral nitrofurantoin monohydrate/macrocrystals
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
OTHERPlacebo
7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Sponsors
NICHD Global Network for Women's and Children's Health
RTI International
University of Virginia
University of Alabama at Birmingham
Thomas Jefferson University
Columbia University
Boston University
University of Colorado, Denver
University of North Carolina, Chapel Hill
International Centre for Diarrhoeal Disease Research, Bangladesh
Kinshasa School of Public Health
Institute of Nutrition of Central America and Panama
Lata Medical Research Foundation, Nagpur
Aga Khan University
University Teaching Hospital, Lusaka, Zambia
KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of small vulnerable newborn (SVN) or stillbirth (SB) | From Pregnancy until 42 days postpartum | SVN/SB, defined by the occurrence of any of the following: * PTB, defined by birth \<37 completed weeks gestation; * SGA, defined by birth weight \<10th percentile of weight for gestational age, using INTERGROWTH 21st international, sex-specific birthweight standards; or * SB, defined by fetal loss or SB \> 22 weeks' gestation. |
Countries
Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia
Outcome results
None listed