- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02703753
TOP-mums, for a Healthy Start
15 de julio de 2020 actualizado por: Maastricht University Medical Center
TOwards Prepared Mums (TOP-mums), for a Healthy Start: A Lifestyle Intervention to Reduce Overweight and Smoking in Women With a Pregnancy Wish to Prevent Perinatal Morbidity
This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity.
Half of the patients will receive the lifestyle intervention while the other half will receive usual care.
It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
112
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dorien Reijnders, PhD
- Número de teléfono: +31 683049082
- Correo electrónico: dorien.reijnders@mumc.nl
Copia de seguridad de contactos de estudio
- Nombre: Anita Vreugdenhil, MD, PhD
- Número de teléfono: +31 43 38 75284
- Correo electrónico: a.vreugdenhil@mumc.nl
Ubicaciones de estudio
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Limburg
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Maastricht, Limburg, Países Bajos, 6229HX
- Reclutamiento
- Maastricht University Medical Center
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Contacto:
- Dorien Reijnders, PhD
- Número de teléfono: +31683049082
- Correo electrónico: dorien.reijnders@mumc.nl
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Women with a pregnancy wish within 1 year;
- Aged 18-40 years;
- Overweight/obesity (BMI ≥ 25 kg/m2).
Exclusion Criteria:
- Haemodynamically significant heart disease;
- Restrictive lung disease;
- Congenital metabolic disease;
- Mentally retarded;
- Bariatric surgery;
- Diabetes type II, dependent on medicine.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
The intervention is an integral and multidisciplinary lifestyle intervention consisting of a healthy diet, appropriate physical activity and, if applicable, smoking cessation, customised to the needs of the women.
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The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
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Sin intervención: Control group
The control group will receive usual care, including standard lifestyle advices during consultation with the GP, midwife, obstetrician or at the child well being centre.
Furthermore, the control group will receive 1 recipe for a healthy meal per week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Reduction in body weight
Periodo de tiempo: From baseline to 6 weeks postpartum
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From baseline to 6 weeks postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Gestational weight gain
Periodo de tiempo: 6 weeks of gestational age to 36 weeks of gestational age
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6 weeks of gestational age to 36 weeks of gestational age
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Postpartum weight retention
Periodo de tiempo: 6 weeks of gestational age to 6 months postpartum
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6 weeks of gestational age to 6 months postpartum
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Smoking cessation
Periodo de tiempo: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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Biochemical verification of tobacco use
Periodo de tiempo: Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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The amount of carbon monoxice (CO) in exhaled breath will be measured using a CO monitor (piCO Baby Smokerlyzer®, Bedfont, Kent, United Kingdom).
Biochemical verification will also be done by measurement of urine cotinine.
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Baseline. Prepregnancy: after 1, 2, 3, 6, 9 and 12 months. During pregnancy: at 6,12,20,32,36 and 40 weeks of gestational age. Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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Dietary habits
Periodo de tiempo: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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By a food diary and the three factor eating questionnaire.
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Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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Physical activity habits
Periodo de tiempo: Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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By an accelerometer and the Baecke questionnaire.
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Baseline. Prepregnancy: after 3 and 12 months. During pregnancy: at 6 and 32 weeks of gestational age. Postpartum: 3 and 12 months.
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Miscarriage
Periodo de tiempo: During pregnancy: at 6, 12 and 20 weeks of gestational age.
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During pregnancy: at 6, 12 and 20 weeks of gestational age.
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Time to pregnancy
Periodo de tiempo: From pregnancy wish to first day of last menstruation
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From pregnancy wish to first day of last menstruation
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Pregnancy complications
Periodo de tiempo: At birth
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Gestational diabetes mellitus, pregnancy-induced hypertension, preeclampsia.
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At birth
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Delivery complications
Periodo de tiempo: At birth
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Caesarean section, induction of labour, vacuum extraction, postpartum haemorrhage, maternal hospital stay, shoulder dystocia.
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At birth
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Vitamin D status
Periodo de tiempo: Will be measured at baseline and at 32 weeks of gestational age.
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Will be measured at baseline and at 32 weeks of gestational age.
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Dysmaturity and macrosomia
Periodo de tiempo: At birth
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At birth
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Prematurity
Periodo de tiempo: At birth
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Birth before 37 weeks of gestational age
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At birth
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Fasting glucose level
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Fasting insulin level
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Insuline resistance (HOMA-IR)
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Total cholesterol
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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LDL cholesterol
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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HDL cholesterol
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Triglycerides
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Free fatty acids
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Alkaline phosphatase
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Gamma-GT
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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ASAT
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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ALAT
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: 3, 6 and 12 months.
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Blood pressure
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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Will be measured at baseline; Prepregnancy: after 1, 2, 3, 6, 9 and 12 months; During pregnancy: at 6, 12, 20, 32, 36 and 40 weeks of gestational age; Postpartum: at 6 weeks and at 3, 6, 9 and 12 months.
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Pulse wave velocity
Periodo de tiempo: Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.
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Will be measured at baseline; Prepregnancy: after 3, 6 and 12 months; During pregnancy: at 6, 20 and 32 weeks of gestational age; Postpartum: at 6 and 12 months.
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Fat mass and fatt free mass
Periodo de tiempo: Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
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Body composition will be measured using the deuterium dilution method
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Will be measured at baseline, at 32 weeks of gestational age during pregnancy and 6 months postpartum
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Fasting glucose level of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Fasting insulin level of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Insulin resistance (HOMA-IR) of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Total cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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LDL cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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HDL cholesterol of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Triglycerides of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Free fatty acids of the child
Periodo de tiempo: At birth and 12 months postpartum
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At birth and 12 months postpartum
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Tidal volume of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
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Will be measured at 6 weeks and 12 months postpartum
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Respiratory rate of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
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Will be measured at 6 weeks and 12 months postpartum
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Respiratory system resistance of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
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Will be measured at 6 weeks and 12 months postpartum
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Respiratory system reactance of the child
Periodo de tiempo: Will be measured at 6 weeks and 12 months postpartum
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Will be measured at 6 weeks and 12 months postpartum
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Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion acetylcholine
Periodo de tiempo: Will be measured at 6 weeks and 3 and 12 months postpartum
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Will be measured at 6 weeks and 3 and 12 months postpartum
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Endothelial vasodilatation of the child: Percentage change between baseline and maximum perfusion nitroprusside
Periodo de tiempo: Will be measured at 6 weeks and 3 and 12 months postpartum
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Will be measured at 6 weeks and 3 and 12 months postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Anita Vreugdenhil, MD, PhD, Maastricht UMC+
- Silla de estudio: Luc Zimmermann, Prof, MD, Maastricht UMC+
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de julio de 2016
Finalización primaria (Anticipado)
1 de diciembre de 2020
Finalización del estudio (Anticipado)
1 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
25 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
3 de marzo de 2016
Publicado por primera vez (Estimar)
9 de marzo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2020
Última verificación
1 de junio de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- METC152026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lifestyle intervention
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
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Shiraz University of Medical SciencesTerminado
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Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
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IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
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The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
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IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
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VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
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Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia