|- candidate number||10347|
|- NTR Number||NTR3068|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2011|
|- Secondary IDs||2011-073 / 2011-000129-61; MEC AMC / Eudract|
|- Public Title||ASB treat study.|
|- Scientific Title||ASB treat study: Costs and effects of screening and treating healthy women for asymptomatic bacteriuria.|
|- hypothesis||To evaluate whether nitrofurantoin treatment for women with asymptomatic bacteriuria is effective in reducing the risk of preterm delivery and/or pyelonephritis (primary outcome) and bad neonatal outcome (secondary outcome). In addition, assessing whether it is cost-effective to screen and treat for ASB.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Preterm birth, Pyelonephritis, Asymptomatic bacteriuria|
|- Inclusion criteria||1. Capacitated women;|
2. ≥18 years old;
3. Singleton healthy pregnancy;
4. Positive urine culture.
|- Exclusion criteria||1. Foetal abnormalities, detected by ultrasound;|
2. Signs of (threatened) preterm labor e.g. painful regular uterine contractions;
3. A history preterm labor <34 weeks;
4. A cervical cerclage in current pregnancy;
5. Symptoms of a urinary tract infection;
6. Known G6PD deficiency or known allergy to nitrofurantoin;
7. Risk factors for complicated UTI (diabetes, immunosuppressive medication, functional or structural abnormalities of the urinary tract).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||320|
|- Interventions||Nitrofurantoine 2dd100mg for 5 subsequent days.|
|- Primary outcome||Main primary outcomes are a composite endpoint of pyelonephritis and preterm delivery (< 34 weeks). Pyelonephritis will be defined as an episode of fever, clinical symptoms and a positive urine culture. |
|- Secondary outcome||Secondary outcome measure is adverse neonatal condition (death or severe morbidity). This composite morbidity rate contains the following variables: Severe Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Haemorrhage grade II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis and death before discharge from the nursery.18 They will be measured until 10 weeks after the expected term date.|
Other parameters are: Neonatal weight, time to delivery, preterm birth rate before 32 and 37 weeks, presence of chorioamnionitis, days of admission in neonatal intensive care unit, maternal morbidity (including UTI), maternal admission days for preterm labour and costs.
Moreover, we will look at growth, physical condition and neurodevelopmental outcome of the offspring at 24 months (corrected) age. If possible, we will stratify for cervical length.
Next to secondary clinical outcome, the cost-effectiveness of screening for asymptomatic bacteriuria (as done in triple P/ ASB screening), and subsequent treatment in case of ASB, will be assessed.
|- Timepoints||Women will be screened between 16-22 weeks of their pregnancy. One week after completing their studymedication their urine will again be tested for asymptomatic bacteriuria|
|- Trial web site||http://www.studies-obsgyn.nl/asb/|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B.M. Kazemier|
|- CONTACT for SCIENTIFIC QUERIES|| B.M. Kazemier|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Obstetrics and Gynaecology |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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 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 to reduce preterm delivery and/or adverse neonatal outcome.
We want to evaluate whether nitrofurantoin treatment for women with asymptomatic bacteriuria is effective in reducing the risk of preterm delivery and/or pyelonephritis (primary outcome) and bad neonatal outcome (secondary outcome). In addition, assessing whether it is cost-effective to screen and treat for ASB|
|- Main changes (audit trail)|
|- RECORD||15-sep-2011 - 21-nov-2011|