E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of recurrent spontaneous preterm birth |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of recurrent spontaneous preterm birth |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 assess the effectiveness of low dose aspirin compared with placebo in the prevention of recurrent spontaneous preterm birth. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pregnant women: >18 years old on inclusion, with a history of spontaneous preterm birth.
Spontaneous preterm birth is defined as: birth following spontaneous contractions with intact membranes or birth after preterm ruptured membranes at a gestational age between 22 and 37 weeks. .
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E.4 | Principal exclusion criteria |
- History of Indicated PTB for maternal reasons such as preeclampsia or HELLP
- History of indicated PTB fetal reasons such as IUGR
- Fetal abnormalities
- Multiple pregnancy either in index or current pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be premature delivery, defined as a gestational age of less than 37 weeks. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The end of the pregnancy resulting in delivery |
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E.5.2 | Secondary end point(s) |
Secondary outcomes will be a composite of poor neonatal outcome (including bronchopulmonary dysplasia, periventricular leucomalacia> grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis and perinatal death), the individual components of the composite perinatal outcome, number of days on ventilation support, days of admission on the NICU, convulsions, asphyxia, proven meningitis, pneumothorax and total days in hospital until 3 months corrected age will be assessed separately.
Furthermore preterm delivery < 28 weeks, < 32 weeks, < 34 weeks of GA will be calculated. As well as birthweight and growth restriction defined as birth weight < p10. Preterm delivery will be analysed as spontaneous, induced or as a combination.
Maternal outcomes include maternal side effects, maternal mortality, maternal morbidity (pregnancy-induced hypertension, preeclampsia, eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, or placental abruption), maternal infection or inflammation, placental abruption, hospital admission in pregnancy and major ante- or post-partum haemorrhage. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Neonatal follow up will take place until 3 months corrected age.
Maternal outcomes will be during the pregnancy and delivery until 6 weeks after the delivery. |
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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 | No |
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 | 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 | Yes |
E.8.2.3 | Other | No |
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 | 20 |
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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Three months (of corrected age) of the neonate after the last participating women giving birth. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |