- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Lise Laclautre
- Telefonnummer: +334752963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Studiesteder
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-
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Clermont-Ferrand, Frankrig, 63000
- Rekruttering
- CHU de Clermont-Ferrand
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Kontakt:
- Lise Laclautre
- Telefonnummer: +334754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
-
Ledende efterforsker:
- Solène Fel
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Calprotectin levels
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
calprotectin level
Tidsramme: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
calprotectin level
Tidsramme: 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
|
|
calprotectin level
Tidsramme: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
calprotectin level
Tidsramme: 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
Tidsramme: 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
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
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at birth
|
|
transciptomic
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
transciptomic
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
transciptomic
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
transciptomic
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
Tidsramme: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Solène FEL, University Hospital, Clermont-Ferrand
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RNI 2026 FEL
- 2026-A00010-51 (Anden identifikator: ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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