New BornCORDOMOUVNCT07579468
Impact of Physical Activity During Pregnancy on Biological Markers at Birth in Cord Blood (CORDOMOUV)
An observational study of New Born, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 2 daysHealthy volunteers can take part
- Conditions the study is for
- New Born
- What is being tested?
- physical activity level during pregnancy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns born to mothers who participated in the PregMouv study
Who may be able to join
- 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.
Who cannot join
- If parents refuse to participate or in situations where parents are protected by law, cord blood collection cannot be done.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +334754963, promo_interne_drci@chu-clermontferrand.fr
Solène Fel
About this study
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.
Read more
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
- Being tested
- physical activity level during pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity level during pregnancyBehavioural
Total physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable)
| Study group | Role | What they receive |
|---|---|---|
| cord blood | Not described Receives: Behavioral: physical activity level during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at birth
Secondary outcomes (11)
calprotectin level
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to delivery mode
Measured: at birth
calprotectin level
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
Measured: at birth
calprotectin level
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to gestational age at birth
Measured: at birth
calprotectin level
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
Measured: at birth
calprotectin level
Calprotectin levels (ng/mL) in umbilical cord blood at birth according to maternal body composition (kg/m²)
Measured: at birth
transcriptomic
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
Measured: at birth
transciptomic
mRNA expression level in umbilical cord blood at birth according to delivery mode
Measured: at birth
transciptomic
mRNA expression level in umbilical cord blood at birth according to maternal physical activity levels during pregnancy at T2
Measured: at birth
transciptomic
mRNA expression level in umbilical cord blood at birth according to gestational age at birth
Measured: at birth
transciptomic
mRNA expression level in umbilical cord blood at birth according to sedentary lifestyle levels at T2 and T3
Measured: at birth
transciptomic
mRNA expression level in umbilical cord blood at birth according to maternal body composition (kg/m²)
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New BornStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solène FEL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579468
- Sponsor's protocol ID
- RNI 2026 FEL
- Other IDs
- 2026-A00010-51
- Acronym
- CORDOMOUV
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity During Pregnancy on Biological Markers at Birth in Cord Blood (CORDOMOUV)
- ClinicalTrials.gov ID
- NCT07579468
- Acronym / sponsor ID
- CORDOMOUV / RNI 2026 FEL
- Conditions
- New Born
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cord blood | – | Behavioral: physical activity level during pregnancy |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns born to mothers who participated in the PregMouv study
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- If parents refuse to participate or in situations where parents are protected by law, cord blood collection cannot be done.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity level during pregnancyTotal physical activity time (in MET minutes/week) of pregnant women measured at Trimestry 3 (explanatory variable) | Behavioural | cord blood |
Primary outcome
Calprotectin levels
Time frame: 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
11 secondary outcomes
calprotectin level
Time frame: at birth
calprotectin level
Time frame: at birth
calprotectin level
Time frame: at birth
calprotectin level
Time frame: at birth
calprotectin level
Time frame: at birth
transcriptomic
Time frame: at birth
transciptomic
Time frame: at birth
transciptomic
Time frame: at birth
transciptomic
Time frame: at birth
transciptomic
Time frame: at birth
transciptomic
Time frame: at birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Solène FEL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Born, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+334752963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calprotectin levels (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.