E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dans le cas de l'Hémorragie du Post Partum (HPP) par une délivrance dirigée. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036417 |
E.1.2 | Term | Hemorragie Postpartum |
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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 |
Démontrer que le traitement préventif de l'HPP par une délivrance dirigée associant oxytocine et misoprostol permet de réduire le risque d'HPP plus efficacement que l'oxytocine seule parmi les patientes ayant un accouchement par les voies naturelles entre 36 et 42 semaines d'aménorrhée (SA). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age >= 18 ans, -Réalisation d'un examen médical préalable (résultats à communiquer à la patiente) -En phase active du travail avec un accouchement anticipé par les voies naturelles, -Bénéficiant d'une analgésie péridurale, -Entre 36 et 42 SA, -Grossesse unique -Affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit) -Signant le consentement éclairé.
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E.4 | Principal exclusion criteria |
-Accouchant par césarienne, -Présentant des troubles de la coagulation, -Présentant une allergie connue aux prostaglandines, -Participant à tout autre essai thérapeutique, -Refusant de signer le consentement éclairé. -Placenta praevia -Grossesse multiple -Mort fÅ“tale in utero -Maladie hémorragique sévère -Mauvaise compréhension de la langue française
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E.5 End points |
E.5.1 | Primary end point(s) |
Critère principal Survenue d'une hémorragie > 500 mL. Critères secondaires Survenue d'une hémorragie > 1000 mL. Délai de délivrance. Nécessité d'utilisation d'autres agents utérotoniques. Transfusions de sang. Recours à un traitement chirurgical (ligature vasculaire, capitonnage des parois utérines, voire hystérectomie d'hémostase), ou radio-interventionnel (embolisation).
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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 | 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 | 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 | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |