E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spontaneous preterm birth |
Parto pretérmino espontáneo |
|
E.1.1.1 | Medical condition in easily understood language |
Spontaneous preterm birth |
Parto pretérmino espontáneo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
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 examine if the prophylactic use of vaginal Utrogestan from the first trimester
of pregnancy in women with twin pregnancy can reduce the incidence of spontaneous delivery before 34 weeks. |
Evaluar si el uso profiláctico de Utrogestan vaginal desde el primer trimestre mujeres con embarazo gemelar puede reducir la incidencia de parto espontáneo antes de las 34 semanas |
|
E.2.2 | Secondary objectives of the trial |
Incidence of spontaneous delivery before 37 weeks;
Birthweight below the 3rd, 5th and 10th centile;
Stillbirth or neonatal death due to any cause;
Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis);
Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion). |
Parto pretémino < 37 semanas de embarazo
Peso al nacimiento por debajo del percentile 3, 5 y 10.
Muerte fetal o neonatal debido a cualquier causa.
Resultado adverso importante antes del alta hospitalaria (hemorragia intraventricular, distress respiratorio, retinopatía del prematuro, enterocolitis necrotizante).
Necesidad de ingreso en la UCI neonatal o neonatología, ventilación, fototerapia,tratamiento por sospecha de sepsis, necesidad de transfusion sanguínea |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 years;
DCDA or MCDA twin pregnancies
Live fetuses at 11-13 weeks of gestation
English or Spanish (otherwise interpreters will be used
Informed and written consent |
Edad > 18 años
Gestación gemelar BC y MCBA
Fetos vivos en las semanas 11-13 de gestación
Lenguaje ingles o español (si no se les proporcionará un intérprete)
Consentimiento informado verbal y por escrito. |
|
E.4 | Principal exclusion criteria |
Age < 18 years
Pregnancies complicated by major fetal abnormality identified at the 11- 13 weeks assessment, including nuchal translucency thickness >3.5 mm;
In MCDA twin pregnancies there are early signs of twin-to-twin transfusion syndrome (TTTS) (20% discordance in crown-rump length [CRL] and/or nuchal translucency [NT]);
Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness;
Hypersensitivity to progesterone;
Concurrent participation in another drug trial or at any time within the previous 28 days;
Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol. |
Edad menor de 18 años.
Gestaciones complicadas con una malformación fetal mayor identificada entre las 11-13 semanas, incluyendo una translucencia nucal (TN) > 3.5 mm.
En MCBA puede haber signos precoces de transfusion feto-fetal (TTTS) 20% de discordancia en la longitud cefalo-caudal (LCC) y/o aumento de la TN.
Mujeres severamente enfermas, problemas mentales, problemas de aprendizaje.
Hipersensibilidad a la progesterona.
Participación en otro estudio con medicación en los 28 días anteriores
Cualquier otro motive que el investigador considere. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of spontaneous delivery before 34 weeks (238 days) |
Parto espontáneo por debajo de la semana 34 (238 días) de gestación. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Data on pregnancy outcome will be collected from hospital maternity records or general practitioners. The obstetric records of all patients delivered at <34 weeks (<238 days) will be examined to determine if the preterm birth is iatrogenic or spontaneous. The latter includes those with spontaneous onset of labour and those with preterm pre-labour rupture of membranes |
Los resultados serán recogidos de la historia clínica hospitalaria o de los médicos de familia. El resultado de las mujeres con un parto <34 semanas (<238 días) será examinado para determinar si el parto pretérmino es iatrogénico o espontáneo. Éste ultimo incluye el comienzo de parto de forma espontánea y la ruptura prematura de membranas de la bolsa amniótica. |
|
E.5.2 | Secondary end point(s) |
Incidence of spontaneous delivery before 37 weeks;
Birthweight below the 3rd, 5th and 10th centile;
Stillbirth or neonatal death due to any cause;
Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis);
Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion). |
Parto pretémino < 37 semanas de embarazo
Peso al nacimiento por debajo del percentile 3, 5 y 10.
Muerte fetal o neonatal debido a cualquier causa.
Resultado adverso importante antes del alta hospitalaria (hemorragia intraventricular, distress respiratorio, retinopatía del prematuro, enterocolitis necrotizante).
Necesidad de ingreso en la UCI neonatal o neonatología, ventilación, fototerapia, tratamiento por sospecha de sepsis, necesidad de transfusion sanguínea |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The incidence of spontaneous preterm birth <37 weeks (259 days) of
gestation;
Birthweight below the 3rd, 5th and 10th centile;
Stillbirth or neonatal death due to any cause.
Major adverse outcomes before discharge from the hospital
(intraventricular haemorrhage, respiratory distress syndrome,
retinopathy of prematurity, or necrotising entercolitis).
Need for neonatal special care (admission to a neonatal intensive care
unit, ventilation, phototherapy, treatment for proven or suspected
sepsis, or blood transfusion). |
Parto pretémino < 37 semanas de embarazo (259 días).
Peso al nacimiento por debajo del percentile 3, 5 y 10.
Muerte fetal o neonatal debido a cualquier causa.
Resultado adverso importante antes del alta hospitalaria (hemorragia intraventricular, distress respiratorio, retinopatía del premature, enterocolitis necrotizante).
Necesidad de ingreso en la UCI neonatal o neonatología, ventilación, fototerapia, tratamiento por sospecha de sepsis, necesidad de transfusion sanguínea |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | 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
| 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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
|
The end of the study for individual participants will be defined as 30 days after the birth of the baby/end of the pregnancy.
The end of the study as a whole will be defined as the last visit of the last patient (n=1,180) with details of their complete pregnancy outcome. |
El final del estudio para los participantes se define como 30 días después del nacimiento del bebé / final del embarazo.
El final del estudio se define como la última visita del último paciente ( n = 1.180 ) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |