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

ConditionNew Born
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-2
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Newborns born to mothers who participated in the PregMouv study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • physical activity level during pregnancy

    Behavioral

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

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: cord blood1 intervention

Trial outcomes

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

Time frame
at birth

Secondary outcomes

1

calprotectin level

Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode

Time frame
at birth
2

calprotectin level

Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2

Time frame
at birth
3

calprotectin level

Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth

Time frame
at birth
4

calprotectin level

Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3

Time frame
at birth

Other outcomes

Sponsors and contacts

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