E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Administración de dinoprostona intravaginal en la inducción del parto en gestantes a término. |
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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 |
Objetivo principal: Determinar el tiempo de progresión hasta el parto, en las gestantes a término, con la administración de dinoprostona (PGE2) en forma de pesario intravaginal durante 8 horas o durante 12 horas en la inducción del parto. |
|
E.2.2 | Secondary objectives of the trial |
Objetivos secundarios: Determinar si la administración del tratamiento durante 8 o 12 horas influye en la tasa de cesáreas comparada con la población general, en la necesidad de oxitocina (cantidad total administrada), en los cambios en el Test de Bishop y en la aparición de efectos secundarios al tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Firma del consentimiento informado. 2 Edad mayor de 18 años. 3 Gestación a término. 4 Presentación cefálica. 5 Índice de Bishop menor de 5 puntos. 6 Gestación única. 7 Patología materna o fetal que aconseje la inducción del parto. 8 Gestación cronológicamente prolongada (41 semanas y 5 días). |
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E.4 | Principal exclusion criteria |
1. Gestación pretérmino. 2 Índice de Bishop igual o mayor a 5 puntos. 3 Gestación gemelar. 4 Ruptura prematura de membranas. 5 Patología materna que contraindique la inducción. 6 Patología obstétrica que contraindique un parto vaginal. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Tiempo en horas hasta el parto, considerado desde la administración de la dinoprostona hasta el momento del parto. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | Yes |
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 |
Mismo medicamento en diferentes pautas de administración |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |