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New treatment option for Preterm Birth
Official title Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
ClinicalTrials.gov ID: NCT06723392
What this study is testing
What is Oral nitrofurantoin monohydrate/macrocrystals?
Oral nitrofurantoin monohydrate/macrocrystals is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preterm birth.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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 \ Some sites will be able to include individuals giving birth regardless of age if they are...
- Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
You likely can't join if
- Individuals who meet any of the following criteria are not eligible for randomization:
- Gestational age \ 20 weeks
- Received treatment with any antibiotic within 14 days before screening visit
- Current symptoms of UTI
- History of allergy to nitrofurantoin
- Pregnancy loss / miscarriage prior to randomization
See the full eligibility 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 \ Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites...
- Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
- Able to provide informed consent
- Presence of a single bacterial isolate (\>105 colony forming unit (CFU)/mL) in urine at enrollment
- Intent to remain in study area for at least 42 days PP
- Individuals who meet any of the following criteria are not eligible for randomization:
- Gestational age \ 20 weeks
- Received treatment with any antibiotic within 14 days before screening visit
- Current symptoms of UTI
- History of allergy to nitrofurantoin
- Pregnancy loss / miscarriage prior to randomization
- Currently taking magnesium-containing antacid
- Any illness / condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment
- Enrollment in another trial that per the study MOP will impact this trial
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh, Bangladesh
- Kinshasa, DRC, Democratic Republic of the Congo
- Guatemala City, Departamento de Guatemala, Guatemala
- Belagavi, Karnataka, India
- Nagpur, Maharashtra, India
- Karachi, Pakistan, Pakistan
- Lusaka, Zambia, Zambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh, Bangladesh; Kinshasa, DRC, Democratic Republic of the Congo; Guatemala City, Departamento de Guatemala, Guatemala; Belagavi, Karnataka, India; Nagpur, Maharashtra, India; Karachi, Pakistan, Pakistan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.