E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preterm birth with healthy singleton 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 | Premature labour |
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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 progesterone in women with a short cervical length can reduce the preterm delivery rate in these women. In addition, we evaluate whether a screening program with cervical length measurement and subsequent progesterone treatment is cost-effective.
Primary outcome is composite bad 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 These will be measured until 10 weeks after the expected term date.
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes are delivery < 34 weeks, time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. Moreover, we will look at growth, physical condition including close examination of the genital tract, and neurodevelopmental outcome of the offspring at 24 months (corrected) age.
In addition, the study design will enable us to compare the costs and effects of the following strategies: I. no screening for cervical length II. screening for cervical length, treatment of women with a short cervical length, and deciding the cut-off levels for the cervical length
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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 -- Two times a cervical length ≤ 25 mm: a cervical length ≤ 25 mm at 16-20 weeks gestation, and a confirmation of this result with a repeat measurement of the cervical length at 20-22 weeks gestation |
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E.4 | Principal exclusion criteria |
Women with a pregnancy with major foetal abnormalities, painful regular uterine contractions, a history of ruptured membranes or a cervical cerclage will be excluded. In addition, women with a previous preterm birth are excluded as well.
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E.5 End points |
E.5.1 | Primary end point(s) |
A composite bad neonatal condition (death or severe morbidity) at 10 weeks corrected age. 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 |
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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) | Information not present in EudraCT |
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 | 21 |
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 1920 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 | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 | 5 |