E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
women during labor |
donne in travaglio di parto |
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E.1.1.1 | Medical condition in easily understood language |
women during labor |
donne in travaglio di parto |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10029772 |
E.1.2 | Term | Normal pregnancy, labour and delivery |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 |
To compare analgesic efficacy of continuous vs intermittent administration of remifentanil at the end of the first hour of labor |
Confrontare l’efficacia analgesica della somministrazione continua vs intermittente di Remifentanil al termine della prima ora del travaglio di parto |
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E.2.2 | Secondary objectives of the trial |
- to compare analgesic efficacy of continuous vs intermittent administration of remifentanil during the whole labor
- to compare the incidence of maternal and neonatal side effects associated with the use of these two methods
- to compare mother’s level of satisfaction towards these two methods at the end of labor |
- Confrontare l’efficacia analgesica della somministrazione continua vs intermittente di Remifentanil durante l’intera durata del travaglio di parto
- Confrontare l’incidenza di effetti collaterali materni e neonatali associati all’utilizzo delle due metodiche
- Confrontare il livello di gradimento materno espresso nei confronti delle due metodiche al termine del travaglio di parto |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- woman in labor with contraindication for peridural analgesia; particularly: ● impaired blood coagulation parameters or impaired platelets count ● hypovolemia (unresponsive to pharmacological treatment) ● sepsis ● infection in the site of insertion of the peridural catheter ● tattoo in the site of insertion of the peridural catheter ● allergy to local anesthetics ● intracranial hypertension ● neurological disease in active phase
- lack of consent (preference for less invasive methods)
- ASA I or II
- cervical dilatation < 5 cm
- cephalic fetal presentation
- age ≥ 18 years
- written informed consent |
- partoriente in travaglio di parto in cui sia controindicata l’analgesia peridurale; in particolare :
● alterazioni dei parametri emocoagulativi e della conta delle piastrine ● ipovolemia non responsiva al trattamento farmacologico ● sepsi ● infezione nel punto di inserimento del catetere peridurale ● tatuaggio nel punto di inserimento del catetere peridurale ● allergia agli anestetici locali ● ipertensione endocranica ● malattia neurologica in fase attiva
- partoriente in travaglio di parto che, rifiutando la peridurale, acconsenta all’analgesia endovenosa con Remifentanil quale metodica analgesica alternativa
- classe ASA I o II
- dilatazione cervicale < 5 cm - presentazione fetale cefalica
- età ≥ 18 anni
- consenso informato scritto |
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E.4 | Principal exclusion criteria |
- previous treatment with analgesic drugs - pre-eclampsia - insulin-dependent diabetes - toxic substance abuse - opioids allergy - pathological obesity (BMI > 40) |
- precedente trattamento con farmaci analgesici - pre-eclampsia - diabete insulino-dipendente - abuso di sostanze tossiche - allergia agli oppioidi - obesità patologica (BMI>40) |
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E.5 End points |
E.5.1 | Primary end point(s) |
in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia and after 60 minutes |
In ogni donna il dolore verrà misurato attraverso la somministrazione di una VAS con scala di valori compresi tra 0 e 10. La valutazione verrà effettuata a 60 minuti dall’introduzione della terapia analgesica ed i valori di VAS ottenuti confrontati con i basali presenti all’inizio dell’analgesia |
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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) |
- in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia, after 5 minutes and every 30 minutes until the end of labor;
- the sedation will be measured through sedation score at the beginning of the analgesia and every 60 minutes until the end of labor;
- woman’s vital signs will be measured at the beginning of labor, every 5 minutes until the first half hour and then every 30 minutes until the end of labor by instruments routinely present in delivery rooms. Particularly heart rate will be evaluated by 3-leads ECG, blood pressure by sphygmomanometers, arterial oxygen saturation by infrared pulse oximetry and respiratory rate by direct measurement;
- mother’s episods of nausea, vomiting or pruritus will be recorded. - fetal heart rate will be measured by cardiotocography continuously during the labor; in particular decreases in heart rate above 20% in respect to time zero (if not associated with uterine contractions) will be sought; - fetal vitality and fetal primary vital functions will be evaluated through Apgar score at the first and fifth minute. A blood gas analysis on the cord blood with cooximetric method and fetal pH will be recorded at the 15th minute and after 2 hours; - In each woman the overall efficacy of these two methods in improving patients’ comfort during the labor will be evaluated through an anonimous satisfaction form with a 5-points evaluation scale. |
- In ogni donna il dolore verrà misurato attraverso la somministrazione di una VAS con scala di valori compresi tra 0 e 10; la valutazione verrà effettuata all’inizio dell’analgesia, dopo 5 minuti ed ogni 30 minuti fino al termine del travaglio di parto.
- La sedazione della partoriente verrà misurata tramite sedation score all’inizio dell’analgesia ed ogni 60 minuti fino al termine del travaglio di parto.
- I parametri vitali della partoriente verranno misurate all’inizio del travaglio, ogni 5 minuti fino alla prima mezzora e quindi ogni 30 minuti fino al suo termine tramite strumentario routinariamente presente nelle sale parto. In particolare la frequenza cardiaca verrà valutata tramite elettrocardiografia a 3 derivazioni, la pressione arteriosa attraverso misurazione incruente tramite sfignomanometria, la saturazione di ossigeno arteriosa tramite pulsossimetria ad infrarossi e la frequenza respiratoria tramite misurazione diretta.
- Verranno registrati eventuali episodi di nausea, vomito e prurito materni. - La frequenza cardiaca fetale verrà misurata con cardiotocografo in continuo durante tutto il travaglio; verranno ricercate, in particolare, diminuzioni della frequenza cardiaca superiori al 20% rispetto al tempo zero non associate a contrazioni uterine. - All’espletamento del parto la vitalità e l’efficienza delle funzioni vitali primarie del neonato verranno valutate tramite la somministrazione del punteggio di Apgar al primo ed al quinto minuto. Verrà inoltre effettuata un esame emogasanalitico da sangue cordonale tramite metodica coossimetrica ed il pH fetale verrà indicato al quindicesimo minuto. - In ogni donna l’efficacia complessiva delle due metodiche nel migliorare il comfort delle pazienti durante il parto verrà valutato tramite un questionario anonimo di gradimento con una scala di misurazione a 5 punti. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
whole length of labor |
l'intera durata del travaglio di parto |
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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 | 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) | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco, altra metodica di somministrazione |
same IMP in other method of administration |
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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
| 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 | 4 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |