E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 improve treatment of labour pain. Study the pharmacodynamics of epidural hydromorphone bolus according to blood concentrations. |
Synnytyskivunlievityksen parantaminen. Selvitämme epiduraalisen 0.75mg:n hydromorfonin kerta-annoksen farmakodynamiikkaa veripitoisuuksien perusteella |
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E.2.2 | Secondary objectives of the trial |
Effect and duration of single dose hydromorphone
side-effects
neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation) |
kerta-annoksen teho ja kesto synnytyskivun lievityksessä
haittavaikutukset
vastasyntyneen vireys (NACS-tutkimus)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
healthy primipara
age 18-45 years
normal fullterm bregnancy
wish for epidural pain relief
no contraindications to epidural or hyrdomorphone
no regular opioid-treatment
no opioids during last 12 hours
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terve ensisynnyttäjä
ikä 18-45v
normaalisti edennyt täysiaikainen raskaus
toive epiduraalisesti kivunlievityksestä
ei vasta-aiheita epiduraalipuudutukselle tai hydromorfonin käytölle
ei opioideja säännöllisessä käytössä
ei ole saanut opioideja viimeisen 12h aikana
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E.4 | Principal exclusion criteria |
immediate need for pain relief
sleep apnea or lung dysfunction
BMI > 35 kg/m2
organ dysfunction
alcohol abuse
MAO-inhibitor use
elevated intracranial pressue
hydromorphone allergy |
välitön kivunlievityksen tarve
uniapnea tai heikentynyt hengitystoiminto
BMI>35 kg/m2
elintoimintahäiriö
pitkäaikainen alkoholin käyttö
MAO-estäjä lääkitys
kohonnut kallonsisäinen paine
allergia hydromorfonille
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E.5 End points |
E.5.1 | Primary end point(s) |
blood concentration of hydromorphone from mother during the labour and from umpilical vein and artery after birth |
hydromorfonin veripitoisuudet äidistä synnytyksen aikana ja napalaskimosta ja valtimosta syntymän jälkeen |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
from mother: 0, 15, 30, 45, 60 min, 2h, 3h, 4h and then every 2 hours until birth
after umbilical cord cutting blood exam from umbilical vein and artery |
äidistä: 0, 15min, 30, 45, 60min, 2h, 3h, 4h ja jatko 2h:n välein synnytykseen saakka
-napanuoran katkaisun jälkeen napalaskimo- ja napavaltimonäyte |
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E.5.2 | Secondary end point(s) |
Effect and duration of single dose hydromorphone
side-effects
neurologic and adaptive capacity scoring system for evaluating new born babies (NACS-evaluation) |
kerta-annoksen teho ja kesto synnytyskivun lievityksessä (NRS)
haittavaikutukset
vastasyntyneen vireys (NACS-tutkimus) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
pain NRS: before epidural hydromorphone, and afterward every 15 minutes (rest and contraction pain)
nausea NRS every 15 min
NACS 30-60min after birth |
kipu NRS: ennen puudutuksen laittoa, puudutuksen laiton jälkeen 15min välein levossa ja supistuksen aikana, aina ennen lisäpuudutuksia
pahoinvointi NRS 15 min välein
NACS 30-60min syntymästä
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
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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We include 15 primiparas and they are monitored during the labour. Study ends after new born has evaluated using NACS. |
Tutkimukseen otetaan 15 synnyttäjää, joita seurataan synnytyssalissa. Yksittäisen tutkittavan tutkimusjakso päättyy lapsen vireystutmuksen jälkeen
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |