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

• Register: ISRCTN
• Last refreshed on: 11 January 2021
• Main ID: ISRCTN11966080
• Date of registration: 14/12/2007
• Prospective Registration: No
• Primary sponsor: World Health Organization (WHO) (Switzerland)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/03/2004
• Target sample size: 900
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11966080
• Study type: Interventional
• Study design: Randomised double blind placebo controlled clinical trial. (Treatment)
• Phase: Not Specified

Countries of recruitment

Argentina, Philippines, Thailand, Viet Nam

Contacts

• Name: Mariana Widmer

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Asymptomatic Bacteriuria (ASB)
Infections and Infestations
Bacteriuria

Intervention(s)

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 Investigator:
Dr Pisake Lumbiganon
Department of Obstetrics and Gynecology
Faculty of Medicine
Khon Kaen University
Khon Kaen, 40002
Thailand
Tel: [phone]
Fax: [phone]
Email: [e-mail]

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

A35024

Source(s) of Monetary Support

World Health Organization (WHO) (Switzerland) (ref: A35024)

Ethics review

Status:
Approval date:
Contact:

Ethics approval received from: 1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 24th November 2003 2. Ethics Committee of the Khon Kaen University on the 17th July 2003 (ref: HE460606) 3. Ethical Committee Ministry of Health Vietnam on the 24th April 2003 4. Ethics Review Board of the College of Medicine - University of the Philippines, Manila on the 28th October 2003

Results

• Results available: Yes
• Date Completed: 01/03/2007