A multicentre, double blind, placebo controlled, randomised trial to evaluate the effectiveness of a one-day versus seven-day regimen of nitrofurantoin for the treatment of asymptomatic bacteriuria in pregnancy

A multicentre, double blind, placebo controlled, randomised trial to evaluate the effectiveness of a 1-day versus 7-day regimen of nitrofurantoin for the treatment of asymptomatic bacteriuria in pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11966080

Enrollment

900

Registered

2007-12-14

Start date

2004-03-01

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Bacteriuria (ASB) Infections and Infestations Bacteriuria

Interventions

Intervention: one-day regimen of nitrofurantoin (100 mg twice a day) Control: seven-day regimen of nitrofurantoin (100 mg twice a day) Contact details for Principal In

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women with gestational age 12 - 32 weeks 2. Willing and able to give consent

Exclusion criteria

Exclusion criteria: 1. Have any underlying disease, which require continuous steroid and/or antibiotic treatment, e.g. systemic lupus erythematosus, valvular heart disease, etc. 2. Use of any antibiotics during the past one-week 3. Received any treatment for urinary tract infection at any time during the current pregnancy 4. History of nitrofurantoin hypersensitivity 5. Plan not to deliver at the study hospital 6. Any symptoms such as flank pain, dysuria that suggests symptomatic Urinary Tract Infections (UTI) 7. Have any haematological disease including Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) 8. Negative urine dipslide 9. Negative urine culture 10. Positive urine culture but the organism is resistant to Nitrofurantoin

Design outcomes

Primary

Measure	Time frame
Bacteriological cure after the antibiotic treatment based on the result of midstream urine culture 14 days after the initiation of the treatment.	—

Secondary

Measure	Time frame
Incidences of: 1. Pyelonephritis 2. Preterm delivery 3. Low birth weight 4. Side effects	—

Countries

Argentina, Philippines, Thailand, Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026