Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Recruiting
Phase 3
Interventional Study
Preterm Birth
Small for Gestational Age (SGA)
Stillbirth
Bacteriuria (Asymptomatic) in Pregnancy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 49
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,134 (estimated)
- Sponsor
- NICHD Global Network for Women's and Children's Health · Research network
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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 e…
Trial Locations
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Eligibility Criteria
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
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Contacts
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