E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
preterm birth |
vroeggeboorte |
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E.1.1.1 | Medical condition in easily understood language |
preterm birth |
vroeggeboorte |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023555 |
E.1.2 | Term | Labour premature |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023545 |
E.1.2 | Term | Labor premature |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036594 |
E.1.2 | Term | Premature birth |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036600 |
E.1.2 | Term | Premature labour |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036599 |
E.1.2 | Term | Premature labor |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 compare the effectiveness of vaginal progesterone and cervical pessary in the prevention of preterm birth in women with singleton and twin pregnancies and a short cervix. |
Vergelijken van de effectiviteit van vaginaal progesteron of pessarium ter preventie van vroeggeboorte in eenling en tweeling zwangerschappen van vrouwen met een korte cervix. |
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E.2.2 | Secondary objectives of the trial |
not applicable |
niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less 2. Twin pregnancy and cervical length at 16 to 22 weeks of 38 mm or less
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1. Eenling zwangerschap en cervixlengte van 35 millimeter of minder bij 18 tot 22 weken zwangerschap 2. Tweeling zwangerschap en cervixlengte van 38 millimeter of minder bij 16 tot 22 weken zwangerschap
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E.4 | Principal exclusion criteria |
1. Cervical cerclage in this pregnancy 2. Maternal age less than 18 years 3. Identified major congenital abnormalities in this pregnancy 4. Death of one or both of the foetuses in this pregnancy 5. Spontaneous preterm birth before 34 weeks in previous pregnancy 6. Participation Quadruple P study in previous pregnancy 7. Cervical length less then 2mm 8. Cervical dilatation of 3cm or more
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1. Cervicale cerclage in deze zwangerschap 2. Leeftijd moeder onder de 18 jaar 3. Geïdentificeerde congenitale afwijkingen in deze zwangerschap 4. Spontane vroeggeboorte voor 34 weken in voorgaande zwangerschap 5. Dood van een of beide foetussen 6. Eerdere deelname aan Quadruple P studie in vorige zwangerschap 7. Cervicale lengte van minder dan 2mm 8. Cervicale dilatatie van 3cm of meer |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome is composite adverse neonatal outcome. This composite outcome contains periventricular leukomalacia (PVL) > grade 1, severe respiratory distress syndrome (RDS) bronchopulmonary Dyplasia (BPD), Intraventricular Haemorrhage grade II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis, stillbirth and death before discharge from the nursery. |
Primaire uitkomstmaat is een samengestelde slechte neontale uitkomst. Deze uitkomst bestaat uit de volgende onderdelen: periventriculaire leukomalacie > graad 1. Ernstig respiratory , bronchopulmonaire dysplasie, intraventriculiare bloeding graad II of hoger, necrotiserende aenterocolitis, bewezen sepsis, intra-uterine vruchtdood en overlijden voor ontslag. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Information will be gathered when pregnancy has finished and the child is discharged. |
Informatie wordt verzameld na de geboorte van het kind en wanneer het kind is ontslagen uit het ziekenhuis. |
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E.5.2 | Secondary end point(s) |
Secondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal and admission days for preterm labour and costs. Follow up of the children will be planned depending on the outcome of the trial. |
Secundaire uitkomstmaten: tijd tot bevalling na behandeling, vroeggeboorte ratio's voor 28, 32, 34 en 37 weken zwangerschap, opname dagen op de neonatale intensive care, maternale morbiditeit, maternale opname dagen en opname dagen voor dreigende vroeggeboorte en kosten. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Information will be gathered when pregnancy has finished and the child is discharged. After the corrected age of 2 years information on long term follow-up will be collected. |
Informatie wordt verzameld na de geboorte van het kind en wanneer het kind is ontslagen uit het ziekenhuis. Tevens wordt bij een gecorrigeerde leeftijd van 2 jaar informatie verzameld of de lange termijn follow-up
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Arabin pessarium |
Arabin pessary |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 33 |
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 | No |
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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If 700 patients are randomized. Or if the data monitoring commission intervenes within the trial process. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |