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.

Study Overview

• Status: Not yet recruiting
• Conditions: New Born
• Intervention / Treatment: Behavioral: physical activity level during pregnancy

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: +334752963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
    • Contact: Lise Laclautre; Phone Number: +334754963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Solène Fel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Newborns born to mothers who participated in the PregMouv study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cord blood	Behavioral: physical activity level during pregnancy; Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
calprotectin level	Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode	at birth
calprotectin level	Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2	at birth
calprotectin level	Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth	at birth
calprotectin level	Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3	at birth
calprotectin level	Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)	at birth
transcriptomic	mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)	at birth
transciptomic	mRNA expression level in umbilical cord blood at birth according to delivery mode	at birth
transciptomic	mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2	at birth
transciptomic	mRNA expression level in umbilical cord blood at birth according to gestational age at birth	at birth
transciptomic	mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3	at birth
transciptomic	mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)	at birth

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Solène FEL, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RNI 2026 FEL; 2026-A00010-51 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No