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).
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
Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
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
Parallel
Oral nitrofurantoin monohydrate/macrocrystals
Drug7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
Placebo
Other intervention7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Number of small vulnerable newborn (SVN) or stillbirth (SB)
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.
Click on the lead sponsor to view all of their trials.
NICHD Global Network for Women's and Children's Health
Lead sponsor
RTI International
Collaborator
University of Virginia
Collaborator
University of Alabama at Birmingham
Collaborator
Thomas Jefferson University
Collaborator
Columbia University
Collaborator
Boston University
Collaborator
University of Colorado, Denver
Collaborator
University of North Carolina, Chapel Hill
Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator
Kinshasa School of Public Health
Collaborator
Institute of Nutrition of Central America and Panama
Collaborator
Lata Medical Research Foundation, Nagpur
Collaborator
Aga Khan University
Collaborator
University Teaching Hospital, Lusaka, Zambia
Collaborator
KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
Collaborator