ASB treat study: Preventing preterm birth with nitrofurantoin: Costs and effects of screening and treating healthy women for asymptomatic bacteriuria’ - ASB treat study

• Conditions: Preterm birth<34wks and pyelonefritis in singleton healthy pregnancies; MedDRA version: 9.1Level: LLTClassification code 10036600Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2011-000129-61-NL
• Lead Sponsor: AMC Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

?Capacitated women
?=18 years old
?Singleton healthy pregnancy
?Positive urine culture

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with a pregnancy with:
- foetal abnormalities, detected by ultrasound
- signs of (threatened) preterm labor e.g. painful regular uterine contractions
- a history preterm labor <34 weeks
- a cervical cerclage in current pregnancy
- symptoms of a urinary tract infection or tract infection with GBS
- known G6PD deficiency
- risk factors for complicated UTI (diabetes, immunosuppressive medication, functional or structural abnormalities of the urinary tract) will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified