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

Study acronym: ABLE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Dec 8, 2025
    • Site details revised at 7 of 7 sites
    v4
  2. Start date: Jun 2025 to Sep 2025
    • Primary completion date: Jun 2028 to Sep 2028
    • Study completion date: Aug 2028 to Nov 2028
    • Site contacts updated at 7 of 7 sites
    v3
  3. Phase: Phase 1 to Phase 3
    • Primary endpoint revised
    • Collaborators: 16 to 15
    • Eligibility criteria expanded, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06723392
Lead Sponsor NICHD Global Network for Women's and Children's Health
Collaborators: 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
Conditions
(from sponsor)		 Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy
Related terms Bacteriuria, Premature Birth, Stillbirth
Enrollment 1,134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov