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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorNICHD Global Network for Women's and Children's Health

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Oral nitrofurantoin monohydrate/macrocrystals
  • Placebo

Treatment groups

1,134 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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