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Impact of Physical Activity During Pregnancy on Biological Markers at Birth in Cord Blood (CORDOMOUV) (CORDOMOUV)

4. maj 2026 opdateret af: University Hospital, Clermont-Ferrand

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

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Newborns born to mothers who participated in the PregMouv study

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
cord blood
Adfærdsmæssigt: physical activity level during pregnancy
Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Calprotectin levels
Tidsramme: 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

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
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
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
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
at birth
calprotectin level
Tidsramme: at birth
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
at birth
transcriptomic
Tidsramme: at birth
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Efterforskere

  • Ledende efterforsker: Solène FEL, University Hospital, Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

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

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med New Born

Kliniske forsøg med physical activity level during pregnancy

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