RecruitingNAINTERVENTIONAL

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

This study is investigating whether the amount of exercise a mother does during pregnancy can affect her baby's heart and lung health shortly after birth. Researchers will also be checking the baby's growth and development up to the age of two years. This is an additional part of a larger study called 'PregMouv', which helps mothers find the best ways to stay active during pregnancy. By comparing babies whose mothers exercised at different levels, this research hopes to understand more about how keeping fit during pregnancy might benefit newborns and their early development. All information will be analysed carefully to ensure accurate results.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

100

Start

15 Oct 2025

Estimated completion

01 Apr 2029

Newborn Infant

What is this study about?

This research is looking into how a mother's physical activity during pregnancy might influence her baby's health. Specifically, it's studying the baby's heart and lung function right after birth. The idea is to see if babies whose mothers exercised more have different measurements for their heart rhythm and how well their lungs are working compared to babies whose mothers exercised less. This work is part of a larger study that helps pregnant women find the best ways to be active.

To do this, after your baby is born, they will have their heart rhythm and oxygen levels monitored for at least six hours. This is usually done while they are still in the hospital. The study will then follow your child's progress until they are two years old. During this time, their height and weight will be checked, and they will have a general health check-up. Parents will also be asked to complete a questionnaire about their child's development, like how they are learning and interacting.

The main goal is to understand if there is a link between how much a mother exercises during pregnancy and how her baby's heart and lungs work, and how they grow and develop. All the information collected will be analysed carefully by researchers who won't know which mother was in which exercise group, to make sure the results are fair and accurate. Ultimately, this study hopes to provide more information about the potential benefits of physical activity during pregnancy for the baby's early life.

Key takeaways

The study explores links between mothers' pregnancy exercise and babies' health.
It checks newborn heart and lung function, then growth up to age two.
No new medicines or treatments are given to babies.
Participation involves monitoring after birth and follow-up check-ups.
Parents can withdraw their child at any point without affecting care.

Who may be eligible?

Your baby might be able to take part in this study if you, as the mother, were already involved in the main PregMouv study and had some information collected about your physical activity during pregnancy. Also, your baby must have been born at Clermont Ferrand University Hospital.

Before your baby can join, you will need to give your permission for them to participate. The study team will explain everything to you clearly so you can make an informed decision.

However, your baby cannot take part if they needed certain strong medications to support their heart in the first few days of life, or if they needed intensive breathing support through a machine that would make it impossible to properly check their oxygen levels. Also, if you do not wish for your baby to participate, or if you are not able to give your consent, then your baby cannot be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was I already a participant in the main PregMouv study?
Was my baby born at Clermont Ferrand University Hospital?
Did my baby NOT need strong heart support medications right after birth?
Did my baby NOT need intensive breathing support that would prevent oxygen monitoring?
Am I able and willing to give permission for my baby to join?

Answer every question to see your result.

What does participation involve?

If your baby takes part, they will have a small device attached to them, called an ECG Holter, to record their heart rhythm for at least 6 hours while they are in the hospital after birth. Another device, an oximeter, will check their oxygen levels at the same time. These are standard, painless tests. There are no medications involved in this study. You, as the mother, would have already had your physical activity tracked during pregnancy as part of the main PregMouv study.

The study will then follow your child's development until they are two years old. This will involve visits where your child's height and weight are measured, usually around their second birthday. They will also have a routine health check-up. You will be asked to fill out a questionnaire about your child's development, for example, about their learning and social skills. The total duration of your child's participation in the study, from birth to age two, is about two years.

Potential risks and benefits

There are no significant risks to your baby from taking part in this study. The tests used, such as monitoring heart rhythm and oxygen levels, are routine and painless. Your baby will not be given any experimental treatments or medications. The potential benefits are that the information gathered could help us better understand how a mother's exercise during pregnancy may impact a baby's heart, lungs, and overall development, which could lead to better advice for pregnant women in the future. You are free to withdraw your consent for your child to participate at any time without giving a reason, and this will not affect your child's medical care in any way.

Locations (1)

CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting

Common questions

What is the study trying to find out?

It's looking at whether exercise during pregnancy affects a baby's heart and lung health, growth, and development up to age two.

What will happen to my baby if they join?

They will have their heart rhythm and oxygen levels monitored after birth, and their growth and development will be checked until they are two years old.

Are there any medicines involved?

No, this study does not involve any medicines or experimental treatments for your baby.

How long will my baby be in the study?

From birth until they are two years old, which is about two years in total.

Can I change my mind about my baby taking part?

Yes, you can withdraw your consent for your baby to participate at any time without affecting their medical care.

How to find out more

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr +33473754963 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.