E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Premature delivery in twin pregnancies |
Accouchement prématuré chez les grossesses gémellaires |
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E.1.1.1 | Medical condition in easily understood language |
Premature delivery in twin pregnancies |
Accouchement prématuré chez les grossesses gémellaires |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028244 |
E.1.2 | Term | Multiple pregnancy affecting fetus or newborn |
E.1.2 | System Organ Class | 100000004868 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036564 |
E.1.2 | Term | Pregnancy multiple |
E.1.2 | System Organ Class | 100000004868 |
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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 |
Reduce the incidence of respiratory distress syndrome in twins |
Réduire l'incidence du syndrome de détresse respiratoire chez les jumeaux |
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E.2.2 | Secondary objectives of the trial |
Reduce the other complications of prematurity in twins
Describe the effectiveness of management of premature labor in twin pregnancy |
Réduire les autres complications de la prématurité chez les jumeaux
Décrire l'efficacité de la prise en charge de la menace d'accouchement prématuré chez les jumeaux |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Sign inform consent
2. Normal twin pregnancy
3. Mother’s age between 18 and 40 years old
4. Premature delivery risk based on cardiotocography analysis (> 6 contractions/30 minutes) with open cervix (> 1 cm) on digital examination and/or ultrasound cervical length < 25 mm
5. Treatment with Atosiban
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1. signature du consentement éclairé
2. grossesse gémellaire avec patiente et fœtus en bonne santé générale
3. patientes entre 18 et 40 ans
4. diagnostic de menace d’accouchement prématuré basé sur l’enregistrement du cardiotocogramme (6 contractions utérines ou plus durant 30 minutes), longueur du col <25 mm à l’échographie endovaginale et/ou plus d’1cm de dilatation au toucher vaginal
5. traitement de la menace d’accouchement prématuré par de l’Atosiban
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E.4 | Principal exclusion criteria |
1. Medical contra-indication for tocolysis (mother or fetus)
2. Fetal distress based on the cardiotocography and/or ultrasound
3. Contra-indication to corticoid (infection)
4. Other treatment with corticoid (local or general)
5. Previous administration of corticoids for lung maturation in this pregnancy
6. Diabetes mellitus with insulin therapy
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1. contre-indication pour la mère ou le fœtus de tocolyser
2. souffrance fœtale, basée sur l’enregistrement du rythme cardiaque fœtal au CTG
3. contre-indication à l’administration de corticoïdes (infection)
4. traitement en cours par corticoïdes (voie locale ou générale)
5. administration antérieure, lors de la grossesse en cours, de corticoïdes pour prévenir le syndrome de détresse respiratoire
6. diabète maternel insulinodépendant
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of respiratory distress syndrom in the two groups
Grade of respiratory distress syndrom in the two groups
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Proportion de syndrome de détresse respiratoire dans les deux groupes
Grade du syndrome de détresse respiratoire dans les deux groupes |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of these criteria at birth and during the stay in neonatalogy |
Evaluation de ces critères à la naissance et durant le séjour en néonatologie |
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E.5.2 | Secondary end point(s) |
Gestational age at delivery
Incidence of other neonatal complications
Need for neonatal surfactant therapy in both groups
Need for ventilator support
Incidence of long-term respiratory complications |
Âge gestationnel au moment de l’accouchement
Incidence d’autres complications néonatales
Nécessité d’un traitement par surfactant
Nécessité d’une ventilation mécanique ou d’un masque C-PAP
Incidence des complications respiratoires à long terme |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the first four criteria at birth and during the stay in neonatology
The incidence of the long-term respiratory complications will be estimated at 12 and 22 months of life |
Evaluation des quatre premiers critères à la naissance et durant le séjour en néonatologie
L'incidence des complications respiratoires à long terme sera évaluée à 12 et 22 mois de vie |
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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 | Yes |
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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Administration de doses différentes |
Other dosis administration |
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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 | 2 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |