E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preterm birth<34wks and pyelonefritis in singleton healthy pregnancies |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036600 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether the use of nitrofurantoin in women with asymptomatic bacteriuria can reduce the preterm delivery rate and pyelonephritis in these women. In addition, we evaluate whether a screening program with urine cultures and subsequent nitrofurantoin treatment is cost effective.
Primary Objective: Primary outcome is a composite of the development of pyelonephritis and delivery before 34 weeks.
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E.2.2 | Secondary objectives of the trial |
The prevalence and risk factors for ASB in symptom free women will be assessed. Secondary outcome is bad neonatal outcome. Other parameter are: neonatal weight, time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity (including UTI), presence of chorioamnionitis, 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.
Next to secondary clinical outcome, the cost-effectiveness of screening for asymptomatic bacteriuria (as done in ASB screening), and subsequent treatment in case of ASB, will be assessed.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Capacitated women ≥18 years old Singleton healthy pregnancy Positive urine culture
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E.4 | Principal exclusion criteria |
Women with a pregnancy with: - 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 - risk factors for complicated UTI (diabetes, immunosuppressive medication, functional or structural abnormalities of the urinary tract) will be excluded.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome is a composite of the development of pyelonephritis and delivery before 34 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial can be concluded when 320 women are included and have delivered |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |