How a mother's physical activity during pregnancy affects a newborn's heart patterns and oxygen levels
Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns
This project will see if how much a pregnant woman exercises changes her baby’s heart rate patterns and oxygen levels after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07264400 on ClinicalTrials.gov |
What this trial studies
This is an ancillary analysis of the PregMouv program linking maternal physical activity (measured by accelerometer in MET/min/week) to newborn physiological recordings. Newborns born at Clermont-Ferrand will have at least six hours of Holter ECG and continuous oximetry recorded during their maternity stay, with blind interpretation of results. Researchers will compare heart rate variability metrics, average oxygen saturation, and time spent below 90% saturation across maternal activity levels and look for correlations. Children will also be followed to age two for growth and neurodevelopmental screening using clinical exam and parent questionnaires (ASQ).
Who should consider this trial
Good fit: Newborns whose mothers participated in the PregMouv study and who are born at Clermont-Ferrand University Hospital with parental consent are eligible.
Not a fit: Newborns needing aminergic support, invasive ventilatory support, or those whose heart-rate or oximetry data cannot be analyzed (or whose parents decline) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could help refine pregnancy exercise advice to support better newborn heart regulation and oxygenation.
How similar studies have performed: Linking maternal exercise to neonatal heart-rate variability and oximetry is a relatively novel approach with limited prior data, although some studies have tied maternal activity to fetal and neonatal outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All newborns of mothers who participated in the PregMouv study and who have at least one piece of data for the main criterion from the PregMouv study (physical activity at T1/T2), * born at the Clermont Ferrand University Hospital and after parental agreement for their child to participate may be included. Exclusion Criteria: * Newborns requiring aminergic support in the first days of life, * making heart rate variability analysis impossible, * having received invasive ventilatory support that does not allow analysis of the oximetry recording. * Parental refusal or inability of parents to give their consent for their child to participate.
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Justine Paysal — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.