- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Lise Laclautre
- Telefonnummer: +334752963
- E-post: promo_interne_drci@chu-clermontferrand.fr
Studieorter
-
-
-
Clermont-Ferrand, Frankrike, 63000
- Rekrytering
- CHU de Clermont-Ferrand
-
Kontakt:
- Lise Laclautre
- Telefonnummer: +334754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Huvudutredare:
- Solène Fel
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
cord blood
|
Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Calprotectin levels
Tidsram: at birth
|
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
|
at birth
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
calprotectin level
Tidsram: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
calprotectin level
Tidsram: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
calprotectin level
Tidsram: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
calprotectin level
Tidsram: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
calprotectin level
Tidsram: at birth
|
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
|
transcriptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
|
transciptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to delivery mode
|
at birth
|
|
transciptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
|
at birth
|
|
transciptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
|
at birth
|
|
transciptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
|
at birth
|
|
transciptomic
Tidsram: at birth
|
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
|
at birth
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Solène FEL, University Hospital, Clermont-Ferrand
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RNI 2026 FEL
- 2026-A00010-51 (Annan identifierare: ANSM)
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