E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The objective is to demonstrate the superiority of remifentanil versus nitrous oxide as adjuvant analgesic treatment to increase the chances of success of external cephalic version in the management of breech presentation in women with singleton pregnancy at term. Another objective is to compare their safety, tolerability and acceptability. |
demostrar la superioridad del Remifentanilo versus el Óxido Nitroso como tratamiento analgésico coadyuvante para aumentar las posibilidades de éxito de la versión cefálica externa en el tratamiento de la presentación podálica en mujeres con gestación simple a termino. Comparar su seguridad, tolerancia y aceptabilidad. |
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E.1.1.1 | Medical condition in easily understood language |
The objective is to demonstrate that the Remifentanilo (analgesic) relieves better the pain produced when doctor tries to turn around the fetus which is in breech position at the end of the pregnancy. |
Demostrar que el analgésico Remifentanilo alivia mejor las molestias que produce el procedimiento de dar la vuelta al feto cuando esta de nalgas en gestantes en la ultima fase del embarazo. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
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 compare the effect of remifentanil vs nitrous oxide on the success rate in external cephalic version at term in singleton pregnancies in breech presentation. |
comparar el efecto del Remifentanilo frente al Óxido Nitroso sobre la tasa de éxito del procedimiento en la versión cefálica externa a término realizada en gestaciones simples en presentación podálica. |
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E.2.2 | Secondary objectives of the trial |
1 - To compare the analgesic effect of both treatments. 2 - To compare their safety. 3 - To compare the satisfaction of pregnant women with both pain treatments. 4 - To explore the factors that influence on the success of ECV in patients receiving remifentanil. 5 - To explore the logistical factors associated with the difficulty in the implementation and dissemination of this technique. 6 - To compare the cesarean rate with both treatments. |
1- Comparar el efecto analgésico de ambos tratamientos. 2- Comparar su seguridad. 3- Comparar la satisfacción de las gestantes con ambos tratamientos analgésicos. 4- Explorar los factores que influyen sobre el éxito de la VCE en las pacientes que reciben Remifentanilo. 5- Explorar los factores logísticos asociados a dificultad en la implantación y difusión de esta técnica. 6- Comparar la tasa de cesáreas con ambos tratamientos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) pregnancy at term (? 37 weeks) b) singleton fetus in breech presentation c) correct fetal cardiotocographic record d) obstetrical ultrasound examination without findings of serious fetal malformations e) indication for the performance of ECV f) acceptance of ECV g) age ? 18 years h) signature of informed consent |
a) gestación a término (? 37 semanas) b) feto único en presentación podálica c) registro cardiotocográfico fetal compatible con buen estado fetal d) exploración ecográfica obstétrica sin hallazgos de malformaciones fetales graves e) indicación para la realización de VCE e ) aceptación de realización de VCE f) edad ? 18 años f) firma del consentimiento informado |
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E.4 | Principal exclusion criteria |
a) Previous version in the same pregnancy b) Contraindications to ECV: 1-Placenta praevia, 2- placental abruption, 3-oligohydramnios (SPD <2), 4-fetal compromise 5-fetal death, 6-severe malformations, 7-multiple pregnancy, 8- Rh sensibilization, 9- uterine abnormalities, 10- clotting disorders; c) Contraindications to Nitrous Oxide: 1-Patients who require pure oxygen ventilation 2- intracranial hypertension 3- disorders of consciousness that impede the cooperation of the patient, 4-Pneumothorax; 5-Emphysematous Bulla, 6-embolism; 7-immersion accident, 8-bloating abdominal 9- facial trauma that affects the area of ??application of the mask,10- patients who received the type gases SF6, C3F8, C2F6 (used in eye surgery), at least in the previous three months. d) Contraindications for remifentanil: hypersensitivity to remifentanil, fentanyl or fentanyl analogs, or any component of its formulation. |
a) Haber tenido una versión previa en el mismo embarazo b) Contraindicaciones para la VCE: 1-Placenta previa; 2-Desprendimiento de placenta; 3-Oligoamnios (SPD<2); 4-Compromiso fetal; 5-Muerte fetal; 6-Malformaciones graves 7-Gestación múltiple; 8-Sensibilización Rh; 9-Anomalías uterinas; 10-Trastornos de coagulación; c) Contraindicaciones para el Oxido Nitroso: 1-Pacientes que precisan ventilación de oxigeno puro 2-Hipertensión intracraneal 3-Alteraciones del estado de conciencia que impidan la colaboración de la paciente; 4-Neumotórax; 5-Bulla enfisematosa; 6-Embolia gaseosa; 7-Accidente por inmersión; 8-Distensión gaseosa abdominal; 9-Traumatismo facial que afecta a la zona de aplicación de la mascarilla; 10-Pacientes que recibieron gases del tipo SF6, C3F8, C2F6 (utilizados en cirugía oftalmológica), al menos en los tres meses previos. d) Contraindicaciones para el Remifentanilo: hipersensibilidad al Remifentanilo, Fentanilo o análogos del Fentanilo o algún componente de su formulación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Outcome variables (efficacy): Primary endpoint: rate (proportion) of successful ECV maneuvers |
Variables de resultado (eficacia): Variable principal: tasa (proporción) de maniobras de VCE con éxito |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is assessed inmediately after the maneuver |
La variable principal se evaluará inmediatamente tras realizar la maniobra. |
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E.5.2 | Secondary end point(s) |
Outcome variables (efficacy): Secondary endpoints: 1- number of attempts made by the obstetrician 2- number of attempts perceived by pregnant women 3- pain experienced by the patient during the ECV (visual analogue scale), 4- satisfaction with the maneuver performed through a questionnaire with 2 questions with closed answers: 1 - How was the experience?, 2 - Would you accept the procedure to be repeated in another pregnancy?),5- data on foetal presentation at delivery, 6- rate (proportion) of Caesarean-sections.7- Morbidity and perinatal outcomes at birth (Apgar scores at 1 and 5 minutes after delivery, acid base balance). 8- Admission rate in the neonatal intensive care unit. 9- Delivery- related Morbidity during the stay in hospital (48 -72 hours after birth).
Outcome variables (security): incidence and characterization (type, severity, resolution) of adverse events and adverse events attributable to the trial treatments. |
Variables de resultado (eficacia): Variables secundarias: 1- numero de maniobras realizadas a cada paciente;2- numero de maniobras percibidas por cada paciente; 3-dolor referido por la paciente al finalizar el procedimiento del VCE. (se utiliza la escala EAV).4- Satisfacción de la paciente con el procedimiento recibido, medido con la respuesta a dos preguntas estandar: a-¿Cómo ha sido la experiencia?, b-¿Se repetiría el procedimiento en otro embarazo?). 5-Tasa de presentación podalicas en el momento de parto.6- Tasa de cesareas. 7-Morbilidad y resultados perinatales en el postparto inmediato (test de Apgar al de 1 y 5 minutos tras el alumbramiento, equilibrio acido base). 8-Tasa de ingresos del neonato en la Unidad de Cuidados Intensivos de Neonatología. 9-Morbilidad relacionada con el parto durante su ingreso (48- 72 horas). Variables de resultado (seguridad): incidencia y caracterización (tipo, severidad, resolución) de eventos adversos y eventos adversos atribuibles a los tratamientos del ensayo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Some outcomes (1-4) are assessed inmediately after the maneuver.
The others (5-9) are assessed after the birth and during the stay in hospital (usually 48- 72 hours) |
Algunas variables (1-4) serán evaluadas inmediatamente despues de realizar la maniobra.
otras (5-9) sérán evaluadas tras el parto y tras el periodo de hospitalización tras el parto (48-72 horas) |
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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 | 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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 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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Cuando se de de alta la ultima madre y el ultimo niño (o a las 72 horas) despues del parto |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |