A Phase 3 interventional study of Oral nitrofurantoin monohydrate/macrocrystals and Placebo in Preterm Birth, Small for Gestational Age (SGA) and Stillbirth, sponsored by NICHD Global Network for Women's and Children's Health. Recruiting at 7 sites in 6 countries. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 3, Interventional, and Treatment
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).
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 1,134 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Individuals who meet the following criteria are eligible for randomization:
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.
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant individuals with AB randomized to receive a 7-day course of oral NM/M 100 mg twice daily (total of 14 doses)
Drug: Oral nitrofurantoin monohydrate/macrocrystals
Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)
Other: Placebo
7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
7-day course of oral placebo 100 mg twice daily (total of 14 doses)
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.
Time frame: From Pregnancy until 42 days postpartum
Started Dec 2025 (actual). Primary completion is estimated for Sep 2028, 33 months after the start.
Of 35 non-industry phase 3 interventional studies under Premature Birth, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 89. This study's planned 33 months is below that.
Counting every sponsor, half of 40 studies reached it within 51 months; a quarter within 28 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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NICHD Global Network for Women's and Children's Health