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

Phase 3

Completed

• Conditions: asymptomatic bacteriuria; treathened preterm delivery; 10010273

• Registration Number: NL-OMON36603
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

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

Exclusion Criteria

- 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 or allergy for nitrofurantoin
- risk factors for complicated UTI (diabetes, immunosuppressive medication, functional or structural abnormalities of the urinary tract) will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pyelonephritis and preterm delivery before 34wk of gestation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-- bad neonatal outcome (composite of neonatal death and morbidity), neonatal<br /><br>weight<br /><br>-- child health, growth and development at 2 years time to delivery<br /><br>-- preterm birth rate before 32 weeks, and before 37 weeks<br /><br>-- days of neonatal admission<br /><br>-- maternal morbidity including UTI<br /><br>-- maternal admission for preterm labour<br /><br>-- costs</p><br>