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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,134
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Icddr,B
Dhaka, Bangladesh, Bangladesh
RECRUITINGKinshasa School of Public Health
Kinshasa, DRC, Democratic Republic of the Congo
NOT_YET_RECRUITINGInstitue for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, Guatemala
NOT_YET_RECRUITINGKLE Academy of Higher Education and Research
Belagavi, Karnataka, India
RECRUITINGLata Medical Research Foundation
Nagpur, Maharashtra, India
NOT_YET_RECRUITINGAga Khan University
Karachi, Pakistan, Pakistan
NOT_YET_RECRUITINGUniversity Teaching Hospital
Lusaka, Zambia, Zambia
NOT_YET_RECRUITINGNumber 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.
Time frame: From Pregnancy until 42 days postpartum
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