ASB treat study.

ASB treat study: Costs and effects of screening and treating healthy women for asymptomatic bacteriuria.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24261

Enrollment

320

Registered

2011-09-15

Start date

2011-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asymptomatic bacteriuria, pregnancy, preterm birth, pyelonephritis asymptomatische bacteriurie, zwangerschap, vroeggeboorte, nierbekkenontsteking

Interventions

Nitrofurantoine 2dd100mg for 5 subsequent days.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Capacitated women; 2. ≥18 years old; 3. Singleton healthy pregnancy; 4. Positive urine culture.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactB.M. Kazemier

Afdeling verloskunde en gynaecologie AMC Meibergdreef 9

b.m.kazemier@amc.uva.nl+31 (0)6 30471389

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)