Actively Recruiting
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
Led by NICHD Global Network for Women's and Children's Health · Updated on 2026-01-22
1134
Participants Needed
7
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
NICHD Global Network for Women's and Children's Health
Lead Sponsor
R
RTI International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of antibiotic treatment on asymptomatic bacteriuria (AB) during pregnancy in low- and middle-income countries. This phase 3 randomized controlled trial aims to reduce the incidence of small vulnerable newborns (SVN) and stillbirths (SB), contributing to global health goals to prevent early childhood deaths. The study involves pregnant individuals and newborns across seven international sites collaborating with the NICHD Global Network for Women's and Children's Health Research. Participants with AB are randomly assigned to one of two groups: one group receives a 7-day course of oral nitrofurantoin monohydrate/macrocrystals at 100 mg twice daily (14 doses total), while the other group receives a matching placebo on the same schedule. The study compares the impact of this antibiotic treatment versus placebo during pregnancy. During the study, participants will complete screening, randomization, treatment, and follow-up visits, with monitoring continuing until 42 days after birth. Researchers will assess the number of small vulnerable newborns or stillbirths as the main outcome. Participants must remain in the study area for the full postpartum follow-up period, during which health and safety are monitored carefully.
CONDITIONS
Brief Title
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in GN MNHR
- Pregnant with gestational age between 12 and 20 weeks by last menstrual period, clinical assessment, or ultrasonography
- Age between 18 and 49 years (some sites may include emancipated minors or adults of any age per local rules)
- Understands study procedures and willing to complete screening, randomization, treatment, and follow-up
- Able to provide informed consent
- Presence of single bacterial isolate (>105 CFU/mL) in urine at enrollment
- Plans to remain in study area for at least 42 days postpartum
You will not qualify if you...
- Gestational age less than 12 weeks or greater than 20 weeks
- Received antibiotic treatment within 14 days before screening
- Current symptoms of urinary tract infection
- History of allergy to nitrofurantoin
- Pregnancy loss or miscarriage before randomization
- Currently taking magnesium-containing antacid
- Any illness or condition needing immediate medical care as assessed by site investigator
- Enrollment in another trial that may impact this study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a 7-day course of oral nitrofurantoin monohydrate/macrocrystals or placebo, taken twice daily.
1 baseline visit and 1 follow-up visit
Duration - Up to 42 days postpartum
Participants are followed up until 42 days postpartum to monitor newborn outcomes and any adverse effects.
Approximately 1 to 2 visits depending on postpartum schedule
Trial Site Locations
Total: 7 locations
1
Icddr,B
Dhaka, Bangladesh, Bangladesh
Actively Recruiting
2
Kinshasa School of Public Health
Kinshasa, DRC, Democratic Republic of the Congo
Not Yet Recruiting
3
Institue for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, Guatemala
Not Yet Recruiting
4
KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
Actively Recruiting
5
Lata Medical Research Foundation
Nagpur, Maharashtra, India
Not Yet Recruiting
6
Aga Khan University
Karachi, Pakistan, Pakistan
Not Yet Recruiting
7
University Teaching Hospital
Lusaka, Zambia, Zambia
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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