E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059204 |
E.1.2 | Term | Labour pain |
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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 |
Main objective of the trial is to show that relief of labour pain with remifentanil that mother adjusts itself in patient controlled infusion mode using also a basal infusion is more effective in terms of pain reduction, greater satisfaction with the method and frequency of side effects compared to the protocol without basal infusion and comparable regarding safety for the newborn and mother. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are to describe the frequency of accompanying phenomena, remifentanil impact on the duration of the first birth period, impact on the way of delivery and the need for more intensive measures with the newborn immediately at birth and in the immediate postpartum period |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age over 18 years - Body weight between 50 and 100 kg - Spontaneous or induced labour - Request for the relief of pain birth - Gestational age of fetus at least 35 weeks - Cephalic presentation - CTG normal before the start of pain relief
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E.4 | Principal exclusion criteria |
- Allergy to opioids - History of illegal drugs use or alcohol dependency - Age under 18 years - Diabetes, pregnancy induced arterial hypertension - Contraindication for use of labour epidural analgesia (bleeding disorders, infection at the injection site, fear of epidural puncture and its consequences, ...) - Pathological CTG before the start of pain relief / fetal distress from any cause - Twins, breech presentation - IUGR with an estimated fetal weight <2500 g - Congenital / chronic disease in a child found after birth (hereditary diseases, malformations, inherent metabolic disorders , ...) |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Is there a difference in the quality of pain relief during labor between the two groups? (N-VAS-pain, VAS-satisfaction)
- What is the probability of neonatal respiratory depresion? - Is there a difference in remifentanil blood concentration between newborns in the two groups at delivery? (remifentanil blood concentration)
- Is the use of remifentanil during labour safe? (maternal sedation, saturation, respiratory rate, heart rate, blood pressure, arterial blood gas analysis, nenatal CTG, Apgar 1st and 5 and 10 minutes) |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | 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 |
diffrent administration protocol |
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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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |