E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a placebo – controlled longitudinal study to determine whether maternal administration of an unique oral dose of sildenafil citrate (50mg) improves placental flow in first trimester in healthy pregnancies. They are pregnant women before twelve weeks who comes to our hospital for legal medical abortion. |
Se trata de un estudio longitudinal con grupo control ( placebo) para determinar si la administración de una dosis única de 50mg de citrato de sildenafilo puede aumentar la vasscularización placentaria en el primer trimestre en embarazos sanos. Son mujeres embarazadas por debadjo de doce semana que acuden para solicitar la interrupción legal de su embarazo. |
|
E.1.1.1 | Medical condition in easily understood language |
The vascular effect of Sildenafil will be tested in early pregnancy. |
El efecto vascular del sildenafilo en la gestación temprana. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10036585 |
E.1.2 | Term | Pregnancy, puerperium and perinatal conditions |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10036569 |
E.1.2 | Term | Pregnancy related circumstances |
E.1.2 | System Organ Class | 100000004869 |
|
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 whether maternal administration of an unique oral dose of sildenafil citrate improves the placental flow. It will be measured by standard vascular indexes acquired with three dimensional angiopower doppler output. |
Determinar si una dosis única de citrato de sildenafilo aumenta el flujo placentario. Para ello se emplearán índices vasculares semicuantiativos estandarizados de angiopower 3D |
|
E.2.2 | Secondary objectives of the trial |
Uterine artery hemodynamic flow effect and maternal blood pressure and heart frequency variation. |
El efecto sobre las arterias uterinas, y la presión arterial y frecuencia cardíaca maternas. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
After abortion has been practised placental tissue samples (n= 10) from each studied group containing trophoblast tissue will be obtained they will be processed in order to examine angiogenic factors and its histologic structure. |
Tras el aborto legal las muestras de tejido placentario conteniendo trofoblasto (n:10) de cada grupo serán estudiadas buscando factores angiogénicos y/o estructura histológica. |
|
E.3 | Principal inclusion criteria |
1. Healthy women between 20-40 years old. 2. Confirmed pregnant viability without any obstetric complication. 3. First trimester gestational age. |
1. Mujeres sanas embarazadas entre 20-40 años. 2. Embarazo confirmado sin complicaciones obstétricas. 3. Edad gestacional de primer trimestre. |
|
E.4 | Principal exclusion criteria |
- Obstetric risk factors : recurrent miscarriage, previous preeclamsia and hematology disease. - Current use of vasoactive drugs. ( mainly related to hypertension treatment). - Toxic substances abuse. - Threatened abortion symptoms. - Sildenafil Citrate contraindications, as are described in the prescribing information formulary ( exluding pregnancy). |
- Factores de riesgo obstétrico: Aborto recurrente, preclasia previa, o enfermedades hematológicas. - Uso de fármacos vasoactivos: Fundamentalmente relaionadas con la hipertensión - Abuso de sustancias tóxicas. - Síntomas de amenaza de aborto. - Contraindicaciones de Sildenafilo, tal como vienen descritos en ficha técnica ( excepto el embarazo). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Significant variation in the three values representing vascularity adquired automatically : VI as a vascularity index representing the proportion of blood vessels within the tissue, which is calculated as a percentage of colour voxels in the studied volume. FI representing the average power Doppler amplitude within blood vessels. It is calculated as the average value of all colour voxels and it is expressed as a scale of 0– 100. VFI, expressed as a scale of 0–100, is the average colour value of all grey and colour voxels, a product of the number of colour voxels represented as a percentage and the relative amplitude of these voxels. |
Una rvariación significativa de cualquiera de los siguientes índeces vasculares ecográficos otenidos automáticamnete: VI , indice de vascularización ( porcentaje de vasos en el volumen estudiado); FI, indice de fujo (porcentaje de amplitud del color en el volumen estudiado); VFI, que representa la densidad de vascularización, es la media de color respecto a la escala de grises. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
An initial scan is performed when the patient is admitted and another examination is done one hour later (following drug or placebo administration). |
Una evaluación ecográfica basal es realizada al ingreso y otro examen ecográfico se realiza pasada una hora de la administración ( del fármaco o el placebo). |
|
E.5.2 | Secondary end point(s) |
Significative variation of uterine artery hemodynamic flow and maternal blood pressure and heart frequency. |
Variaciones significativas en el flujo hemodinámico de la arteria uterina y en la presión arterial y frecuencia cardíaca maternas. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Blood pressure and maternal heart rate every 15 minutes and side effects will be achieved. Patients are also contacted by telephone to detect side effects twelve hours later and seven days after legal abortion has been done. |
La presión arterial y la frecuencia cardíaca materna serán registardas cada 15 minutos tras la administración de sildenafilo. Los efectos secundarios se evaluarán telefónicamente a als 12 horas y a los siete dias de la administración. |
|
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 | Yes |
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 | 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
|
LVLS |
LVLS. Ultima visita de la ultima paciente. |
|
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 |