To evaluate whether nitrofurantoin treatment for women with asymptomatic bacteriuria is effective in reducing the risk of preterm delivery and/or pyelonephritis. In addition, assessing whether it is cost-effective to do so.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pyelonephritis and preterm delivery before 34wk of gestation
Secondary outcome
-- bad neonatal outcome (composite of neonatal death and morbidity), neonatal
weight
-- child health, growth and development at 2 years time to delivery
-- preterm birth rate before 32 weeks, and before 37 weeks
-- days of neonatal admission
-- maternal morbidity including UTI
-- maternal admission for preterm labour
-- costs
Background summary
Spontaneous preterm delivery is the single most important cause of perinatal
mortality in the
Western world. Antibiotic treatment is effective in clearing asymptomatic
bacteriuria (ASB) and reducing pyelonephritis and is associated with a
reduction in the incidence of low birth weight babies. However, no study
performed so far has been able to show a statistically significant effect on
neonatal outcome.
Study objective
To evaluate whether nitrofurantoin treatment for women with asymptomatic
bacteriuria is effective in reducing the risk of preterm delivery and/or
pyelonephritis. In addition, assessing whether it is cost-effective to do so.
Study design
Multicenter randomized clinical trial.
Intervention
Nitrofurantoin 2x100 mg or placebo for 5 days.
Study burden and risks
Nitrofurantoin capsules containing 100 mg nitrofurantoin or placebo capsules
have to be administered orally by patients, 2 times a day for 5 consecutive
days. We don*t expect patients to experience this as a burden. Patients
participating in the trial, have an increased risk of pyelonephritis and
possible preterm birth. They will benefit from participating in the trial if
treating their ASB with nitrofurantoin decreases the rate of pyelonephritis and
preterm delivery.
Postbus 22700
1105 DE Amsterdam
NL
Postbus 22700
1105 DE Amsterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000129-61-NL |
| CCMO | NL35375.018.11 |