- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Lise Laclautre
- Número de telefone: +334752963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Locais de estudo
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Clermont-Ferrand, França, 63000
- Recrutamento
- CHU de Clermont-Ferrand
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Contato:
- Lise Laclautre
- Número de telefone: +334754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Investigador principal:
- Solène Fel
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Calprotectin levels
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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calprotectin level
Prazo: at birth
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
transciptomic
Prazo: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
transciptomic
Prazo: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
Prazo: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Solène FEL, University Hospital, Clermont-Ferrand
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- RNI 2026 FEL
- 2026-A00010-51 (Outro identificador: ANSM)
Informações sobre medicamentos e dispositivos, documentos de estudo
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