- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07579468
Impact of Physical Activity During Pregnancy on Biological Markers at Birth in Cord Blood (CORDOMOUV) (CORDOMOUV)
Currently, an interventional protocol for physical activity during pregnancy is underway at the Clermont University Hospital (PREGMOUV study). In addition, we have implemented a protocol for 2 years monitoring of children birthed of this study (NEOMOUV study).
Recent data from the scientific literature show that a woman's engagement in regular and appropriate physical activity during her pregnancy presents few dangers while ensuring benefits for the mother-baby dyad. Indeed, physical activity reduces maternal complications such as preeclampsia, gestational diabetes and depression and has many advantages for the child with in particular a reduction in the risk of macrosomia then obesity and diabetes.
Neonatal sepsis is a major risk factor for childhood mortality. There is strong negative association between cord blood levels of calprotectin and sepsis risk in human newborns with levels of calprotectin at birth are significantly lower in infants that later experience blood-culture-proven late-onset neonatal sepsis. In adults, plasma calprotectin levels increase following acute exercise. However after 4 weeks trainging plasma calprotectin level decrease. So in response to acute exercise, plasma calprotectin levels increase but in contrast, there is a negative association between basal plasma calprotectin levels and regular physical activity. Therefore, we do not know what impact mother' regular physical activity can have on the level of calprotectin in the cord blood.
The objective of this project is to investigate the impact of physical activity during pregnancy on calprotectin value at cord blood.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lise Laclautre
- Número de teléfono: +334752963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63000
- Reclutamiento
- CHU de Clermont-Ferrand
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Contacto:
- Lise Laclautre
- Número de teléfono: +334754963
- Correo electrónico: promo_interne_drci@chu-clermontferrand.fr
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Investigador principal:
- Solène Fel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Newborns born to mothers who participated in the PregMouv study (which aims to evaluate an intervention allowing women to better adhere to physical activity: program free/face-to-face/videoconference/mixed) and born at the Clermont Ferrand University Hospital.
Exclusion Criteria:
- If parents refuse to participate or in situations where parents are protected by law, cord blood collection cannot be done.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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cord blood
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Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Calprotectin levels
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL), collected from cord blood immediately after birth according to Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3
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at birth
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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calprotectin level
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
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at birth
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calprotectin level
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
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at birth
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calprotectin level
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth
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at birth
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calprotectin level
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
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at birth
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calprotectin level
Periodo de tiempo: at birth
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Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
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at birth
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transcriptomic
Periodo de tiempo: at birth
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mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
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at birth
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transciptomic
Periodo de tiempo: at birth
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mRNA expression level in umbilical cord blood at birth according to delivery mode
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at birth
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transciptomic
Periodo de tiempo: at birth
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mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
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at birth
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transciptomic
Periodo de tiempo: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
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at birth
|
|
transciptomic
Periodo de tiempo: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
Periodo de tiempo: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
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at birth
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Solène FEL, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- RNI 2026 FEL
- 2026-A00010-51 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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