Preterm BirthPhase 3ABLENCT06723392
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
A Phase 3 study testing Oral nitrofurantoin monohydrate/macrocrystals in people with Preterm Birth and Small for Gestational Age (SGA), run by NICHD Global Network for Women's and Children's Health at 7 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Small for Gestational Age (SGA), Stillbirth
- What is being tested?
- Oral nitrofurantoin monohydrate/macrocrystals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,134 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 8 Dec 2025to Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.
- Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
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- 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
Who cannot join
- Individuals who meet any of the following criteria are not eligible for randomization:
- 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
- Pregnancy loss / miscarriage prior to randomization
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- 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
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
India2 sites, 2 recruiting
- Recruiting
KLE Academy of Higher Education and Research
Belagavi, Karnataka
Shivaprasad S Goudar, MD, MHPE, 919448126371, sgoudar@jnmc.edu
Shivaprasad S Goudar, MD, MHPE
- Not yet recruiting
Lata Medical Research Foundation
Nagpur, Maharashtra
Archana Patel, MD, DNB, MSCE, PhD, Dr_apatel@yahoo.com
Archana Patel, MD, DNB, MSCE, PhD
Bangladesh1 site, 1 recruiting
- Recruiting
Icddr,B
Dhaka, Bangladesh
Rashidul Haque, MD, (880-2)9827001-10, rhaque@icddrb.org
Rashidul Haque, MD
Democratic Republic of the Congo1 site, 1 recruiting
- Not yet recruiting
Kinshasa School of Public Health
Kinshasa, DRC
Antoinette Tshefu, MD, PhD, MPH, antotshe@yahoo.com
Antoinette Tshefu, MD, PhD, MPH
Guatemala1 site, 1 recruiting
- Not yet recruiting
Institue for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala
Manolo Mazariegos, MD, MPH, mmaziergos@incap.org
Manolo Mazariegos, MD, MPH
Pakistan1 site, 1 recruiting
- Not yet recruiting
Aga Khan University
Karachi, Pakistan
Sarah Saleem, MD, sarah.saleem@aku.edu
Sarah Saleem, MD
Zambia1 site, 1 recruiting
- Not yet recruiting
University Teaching Hospital
Lusaka, Zambia
Elwyn Chomba, MBChB, DCH, MRCP, chombaelwyn@gmail.com
Elwyn Chomba, MBChB, DCH, MRCP
About this study
Official title: Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research
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).
- Conditions
- Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy
- Being tested
- Oral nitrofurantoin monohydrate/macrocrystals, Placebo
- Keywords
- asymptomatic bacteriuria, small vulnerable newborn, preterm birth, small for gestational agea, still birth, SVN/SB, oral nitrofurantoin monohydrate/macrocrystals, Global Network, Bangladesh, India, Pakistan, Democratic Republic of Congo, Zambia, Guatemala
- Medical subject headings
- Premature Birth, Stillbirth, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nitrofurantoin monohydrate/macrocrystalsDrug
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
PlaceboOther
7-day course of oral placebo 100 mg twice daily (total of 14 doses)
| Study group | Role | What they receive |
|---|---|---|
| Oral nitrofurantoin monohydrate/macrocrystals | Experimental | Pregnant individuals with AB randomized to receive a 7-day course of oral NM/M 100 mg twice daily (total of 14 doses) Receives: Drug: Oral nitrofurantoin monohydrate/macrocrystals |
| Placebo | Placebo comparator | Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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.
Measured: From Pregnancy until 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start8 Dec 2025
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-arm, double-blind, placebo-controlled, 2:1 allocation, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723392
- Sponsor's protocol ID
- CP ABLE
- Acronym
- ABLE
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No