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- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Lise Laclautre
- Telefoonnummer: +334752963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Studie Locaties
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Clermont-Ferrand, Frankrijk, 63000
- Werving
- CHU de Clermont-Ferrand
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Contact:
- Lise Laclautre
- Telefoonnummer: +334754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Hoofdonderzoeker:
- Solène Fel
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Calprotectin levels
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
calprotectin level
Tijdsspanne: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
|
at birth
|
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calprotectin level
Tijdsspanne: 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
Tijdsspanne: 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
|
|
calprotectin level
Tijdsspanne: 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
|
|
calprotectin level
Tijdsspanne: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
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at birth
|
|
transcriptomic
Tijdsspanne: 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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transciptomic
Tijdsspanne: at birth
|
mRNA expression level in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
transciptomic
Tijdsspanne: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
transciptomic
Tijdsspanne: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
transciptomic
Tijdsspanne: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
Tijdsspanne: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Solène FEL, University Hospital, Clermont-Ferrand
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- RNI 2026 FEL
- 2026-A00010-51 (Andere identificatie: ANSM)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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