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
- Conditions
- Asymptomatic Bacteriuria (ASB)Infections and InfestationsBacteriuria
- Registration Number
- ISRCTN11966080
- Lead Sponsor
- World Health Organization (WHO) (Switzerland)
- Brief Summary
2009 results in https://pubmed.ncbi.nlm.nih.gov/19155904/ (added 30/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 778
1. Pregnant women with gestational age 12 - 32 weeks
2. Willing and able to give consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacteriological cure after the antibiotic treatment based on the result of midstream urine culture 14 days after the initiation of the treatment.
- Secondary Outcome Measures
Name Time Method <br> Incidences of:<br> 1. Pyelonephritis<br> 2. Preterm delivery<br> 3. Low birth weight<br> 4. Side effects<br>