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…
ID
Bron
Verkorte titel
Aandoening
asymptomatic bacteriuria, pregnancy, preterm birth, pyelonephritis
asymptomatische bacteriurie, zwangerschap, vroeggeboorte, nierbekkenontsteking
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Nitrofurantoine 2dd100mg for 5 subsequent days.
Publiek
Meibergdreef 9
B.M. Kazemier
Amsterdam 1105 AZ
The Netherlands
+31 (0)6 30471389
b.m.kazemier@amc.uva.nl
Wetenschappelijk
Meibergdreef 9
B.M. Kazemier
Amsterdam 1105 AZ
The Netherlands
+31 (0)6 30471389
b.m.kazemier@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Capacitated women;
2. ≥18 years old;
3. Singleton healthy pregnancy;
4. Positive urine culture.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2921 |
| NTR-old | NTR3068 |
| Ander register | MEC AMC / Eudract : 2011-073 / 2011-000129-61; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |