E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fist child delivery with epidural |
Accouchement sous péridurale du premier enfant. |
|
E.1.1.1 | Medical condition in easily understood language |
Fist child delivery with epidural |
Accouchement sous péridurale du premier enfant. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 determine the incidence of instrumentated deliveries and caesarean sections according to the mode of administration of the local anesthetic in the epidural. |
Déterminer l'incidence d'accouchement instrumenté et de césarienne selon le mode d'administration de l'anesthésique local dans la péridurale. |
|
E.2.2 | Secondary objectives of the trial |
- To determine the quality of the analgesia according to the administration mode of the epidural
- To assess the satisfaction of the mother
- To evaluate the presence of a motor block at the beginning of the second stage of the labor |
- Évaluer la qualité de l'analgésie selon le mode d'administration, en se basant sur le nombre d'interventions nécessaires de la part de l'anesthésiste
- Évaluer la satisfaction maternelle
- Évaluer la présence de bloc moteur au début du deuxième stade du travail
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women over 18 years of age
- Primiparous
- Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
- Written informed consent
- Cervical dilatation between 3 and 6 cm at recruitment
- Single pregnancy
- Foetus in cephalic position |
- Femmes de 18 ans et plus
- Primipare
- Grossesse > 36 semaines d'âge gestationnel et < 42 semaines
- Consentement écrit recueilli
- Dilatation du col au moment du recrutement comprise entre 3 et 6 cm
- Grossesse unique
- Foetus en position céphalique |
|
E.4 | Principal exclusion criteria |
- Participation refusal or epidural contra-indication
- Multiparous
- Allergy to the products used
- Twin pregnancy
- Height <1m55 and/or narrow pelvis, as shown by imagery
- Langage barrier
- Patients with a BMI superior or equal to 35 (computed with the weight at the beginning of the pregnancy)
- Cervical dilatation at recruitment <3 or >6 cm
- ASA 3 or 4
- Foetus in transverse or seat position |
- Refus ou contre-indication à la péridurale
- Multipare
- Allergie aux produits utilisés
- Grossesse gémellaire
- Taille < 1m55 et/ou bassin étroit démontré à l'imagerie
- Barrière linguistique
- Patientes avec IMC ≥ 35 (calculé avec le poids en début de grossesse)
- Dilatation du col au moment du recrutement < 3 ou > 6 cm
- ASA 3 ou 4
- Foetus en position transverse ou de siège
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E.5 End points |
E.5.1 | Primary end point(s) |
Delivery mode: vaginal, instrumentated (suction cups, forceps) or caesarian section. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Number of anesthesist interventions, either by patient request (pain), either by side effects monitoring
- Maternal satisfaction: visual questionnaire on a scale from 0 to 100, regarding perceived analgesia and anesthesist management
- Presence of a motor block: assessed by the Bromage modified score |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Number of anesthesist interventions: from the beginning of epidural administration by the anesthesist (T0) till delivery
- Maternal satisfaction: the day after the delivery
- Motor Block: at the begining of the second stage of labor, as defined as the complete cervical dilatation |
|
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 | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 |
Different modes of administration of the same solution (continuous infusion vs bolus) |
|
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
| 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |