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

NCT07579468 | Not Yet Recruiting

• 2 other identifiers: RNI 2026 FEL2026-A00010-51
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

New Born

Outcome Measures

Primary Outcomes (1)

• Calprotectin levels

  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

Secondary Outcomes (11)

• calprotectin level

  at birth

• calprotectin level

  at birth

• calprotectin level

  at birth

• calprotectin level

  at birth

• calprotectin level

  at birth

Study Arms (1)

cord blood

Behavioral: physical activity level during pregnancy

Interventions

physical activity level during pregnancy BEHAVIORAL

Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)

cord blood

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns born to mothers who participated in the PregMouv study

You may qualify if:

• 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.

You may not qualify if:

• If parents refuse to participate or in situations where parents are protected by law, cord blood collection cannot be done.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cord blood

Study Officials

• Solène FEL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+334752963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

FR (1)