Pregnant WomanPREGMOUVNCT06585085
Physical Activity and Sedentary Behavior During Pregnancy
A study testing In person PA sessions, Interactive videoconference PA sessions and In person and by videoconference (mixed format) PA sessions. in people with Pregnant Woman, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA). Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- In person PA sessions, Interactive videoconference PA sessions and In person and by videoconference (mixed format) PA sessions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2024to Oct 2028
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women of more of 18 years and who are being monitored for pregnancy in the Clermont-Ferrand metropolitan area,
- Planned to give birth in a maternity unit localized in Clermont-Ferrand metropolitan area (CHU Estaing or Clinique de la Chataigneraie),
- Agreeing to be randomized, to follow the physical activity program offered in the Clermont-Ferrand metropolitan area, and to follow up as part of the study,
- Able to give informed consent to participate in the research,
- Affiliated to a social security scheme
- And between 14+0d and 21+6d weeks of gestation.
Show all 25Show fewer
- Non inclusion Criteria:
- Women under guardianship, curators, deprived of liberty or under court protection,
- With a history of recurrent miscarriage,
- Presenting a multiple pregnancy,
- Hemoglobinemia <9g/dL or symptomatic anemia,
- Presenting eating disorders or a BMI ≤ 18.5 or a BMI ≥ 40,
- With orthopedic limitations,
- Presenting cardiovascular or pulmonary disease,
- Uncontrolled thyroid disease,
- Presenting a high level of smoking,
- With significant health problems,
- Premature rupture of membranes,
- Premature labor during this pregnancy or a history of at least 2 premature births,
- Persistent vaginal bleeding,
- Cervical incompetence,
- Evidence of intrauterine growth restriction,
- Uncontrolled epilepsy,
- Diabetes (previous or gestational, diagnosed in the 1st trimester) or chronic hypertension,
- Or having a planned home birth.
Who cannot join
None listed.
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
Chloé BARASINSKI, cbarasinski@chu-clermontferrand.fr
Chloé BARASINSKI
About this study
Official title: Care Pathway Organization in Order to Increase Physical Activity Levels and Limit Sedentary Behavior During Pregnancy: a Randomized Controlled Trial
Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA).
Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).
Read the detailed description
PA has beneficial effects on physical, psychological, and social health, and its regular practice helps to prevent numerous chronic diseases. During pregnancy, PA also has many benefits for women's physical condition, weight gain, gestational hypertension, lower back and pelvic pain, and postpartum depressive symptoms and may also reduce fetal macrosomia and positively affect neurogenesis, language development, memory, and other learning-associated cognitive functions. (CNSF 2021). PA is thus recommended to all pregnant women for 150 to 180 minutes a week, adapted to their health status, physical condition, and course of pregnancy. It is also recommended that women limit their Sedentary Behaviour (SB) (to ≤7 waking h/day) during pregnancy.
No French study has assessed the impact of a PA program during pregnancy, and no published study has proposed videoconference PA sessions during pregnancy. Pregnant women's adherence to PA is a limiting factor found in many interventional studies. Possible changes in maternal behavior in practicing PA and reducing SB during pregnancy could also favorably affect the health of mother and child and thus subsequent PA. Given PA's many benefits and SB's harmful effects during pregnancy, assessing programs that enable pregnant women to both increase PA levels and reduce SB seems pertinent and valuable.
- Conditions
- Pregnant Woman
- Being tested
- In person PA sessions, Interactive videoconference PA sessions, In person and by videoconference (mixed format) PA sessions.
- Keywords
- physical activity, sedentary behaviour, care pathway
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In person PA sessionsBehavioural
Group B women will have access to a weekly program of 3 face-to-face PA sessions. The face-to-face sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. They will also be offered at one or more times depending on the number of groups. Locations and times will be specified on the online booking software. Women can only register for 3 sessions per week.
Interactive videoconference PA sessionsBehavioural
Women in Group C will have access to a weekly program of 3 PA sessions via interactive videoconferencing. These sessions will have the same format as the face-to-face sessions with visualization of the APA professional, visualization of the participants (who can also choose to be masked). The PA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 3 sessions per week.
In person and by videoconference (mixed format) PA sessions.Behavioural
Women in Group D will have access to a weekly program of 3 mixed-format PA sessions, with 2 interactive distance learning sessions and 1 in-person session. The in-person sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. Locations and times will be specified on the online booking software. Women can only register for 1 face-to-face session per week. The other 2 sessions will be offered via interactive videoconferencing. These sessions will have the same format as the in-person sessions, with visualization of the APA professional, visualization of the participants. The APA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 2 videoconference's sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| A - Free PA practice | No intervention | The women in group A (control group) will receive the usual care provided for any pregnancy, i.e. personalised information on physical activity and sedentary behaviour, with the provision of information booklets. They will be free to exercise during their pregnancy |
| B | Experimental | In-person supervised PA sessions Receives: Behavioral: In person PA sessions |
| C | Experimental | Interactive videoconference PA sessions Receives: Behavioral: Interactive videoconference PA sessions |
| D | Experimental | In person and by videoconference (mixed format) PA sessions Receives: Behavioral: In person and by videoconference (mixed format) PA sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's adherence to PA at the end of the second trimester
measurement of the PA level, measured by accelerometer, expressed in MET.minutes/week by wearing a tri-axial accelerometer on the hip
Measured: between 24 and 30 weeks of gestation
Secondary outcomes (35)
women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester
measurement of sedentary time (defined as a state of wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed using a tri-axial hip accelerometer
Measured: between 24 and 30 weeks of gestation
Women's participation at PA sessions
For women in groups B, C and D, rate of sessions completed on the number of eligible sessions according to their randomization group and the socio-demographic criteria
Measured: After 39 weeks of gestation, end of planned participation in sessions
Pregnancy and Postpartum Evolution of PA Time
PA time measured with a tri-axial accelerometer at the hip
Measured: at 4 distinct times: between 24+0d and 30+0d weeks of gestation, between 32+0d and 37+6d weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum
Evolution in sedentary behavior during pregnancy and postpartum
sedentary time (defined as wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed will be compared according to each intervention modality. Sedentary behavior will be measured by wearing a tri-axial accelerometer on the hip
Measured: at 4 distinct times: between 24 and 30 weeks of gestation, between 32+0day and 37+6day weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum
Women's perception of the determinants of their level of physical activity and sedentary behaviour
Qualitative study by means of semi-structured telephone interviews with a minimum of 100 women, i.e. a minimum of 25 women per group, a number to be adapted according to the data saturation that will be obtained
Measured: during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation
Impact of physical activity on maternal antenatal morbidity
occurrence of maternal pathology during pregnancy (gestational arterial hypertension [PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation] and/or, pre-eclampsia [hypertension with albuminuria > 0.3g/L per 24 hours] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA)
Measured: At delivery
Impact of sedentary behaviour on maternal antenatal morbidity
occurrence of maternal pathology during pregnancy (gestational arterial hypertension [PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation] and/or, pre-eclampsia [hypertension with albuminuria > 0.3g/L per 24 hours] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA)
Measured: At delivery
Impact of physical activity on perpartum maternal morbidity
A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss > 500mL in the 24 hours after delivery)"
Measured: 24 hours after delivery
Impact of sedentary behaviour on perpartum maternal morbidity
A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss > 500mL in the 24 hours after delivery)"
Measured: 24 hours after delivery
Impact of physical activity on postpartum maternal morbidity
: presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Measured: 6 months postpartum
Impact of sedentary behaviour on postpartum maternal morbidity
: presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Measured: 6 months postpartum
Impact of physical activity on the experience of childbirth
Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
Measured: 4 weeks postpartum
Impact of sedentary behaviour on the experience of childbirth
Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
Measured: 4 weeks postpartum
Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
Score obtained in the WHOQOL-Bref questionnaire
Measured: between 24 and 30 weeks of gestation
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
Score obtained in the WHOQOL-Bref questionnaire
Measured: between 24 and 30 weeks of gestation
Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
Score obtained in the WHOQOL-Bref questionnaire
Measured: between 32 and 37 SA+6day weeks of gestation
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
Score obtained in the WHOQOL-Bref questionnaire
Measured: between 32 and 37 SA+6day weeks of gestation
Impact of physical activity on the quality of life of pregnant women at 2 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Measured: between 6 and 10 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Measured: between 6 and 10 weeks postpartum
Impact of physical activity on the quality of life of pregnant women at 6 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Measured: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Measured: between 20 and 24 weeks postpartum
Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 24 and 30 weeks of gestation
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 24 and 30 weeks of gestation
Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 32 and 37 SA+6day weeks of gestation
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 32 and 37 SA+6day weeks of gestation
Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum
Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum
Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Measured: between 20 and 24 weeks postpartum
Impact of physical activity on sexual quality of life
Score on the FSFI Female Sexual Function Index questionnaire
Measured: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on sexual quality of life
Score on the FSFI Female Sexual Function Index questionnaire
Measured: between 20 and 24 weeks postpartum
Impact of physical activity on early neonatal morbidity
a composite criterion: "Apgar score <7 at 5 min and/or arterial pH <7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit"
Measured: At delivery
Impact of sedentary behaviour on early neonatal morbidity
a composite criterion: "Apgar score <7 at 5 min and/or arterial pH <7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit"
Measured: At delivery
Impact of physical activity on the newborn's birth weight
occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Measured: At delivery
Impact of sedentary behaviour on the newborn's birth weight
occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Measured: At delivery
Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods
Cost-effectiveness incremental study (including modelling of the gains linked to the reduction in C-section)
Measured: Data collected during the pregnancy and until 2 month of post-partum
cost-utility study analysis from the point of view of health insurance of the proposed intervention methods
Cost-utility study (based on the usefulness felt by women) from the point of view of health insurance using the EQ5D-5L (5 Level Euroqol 5 Dimensions) and a mapping analysis of the WHOQOL-Bref
Measured: Data collected during the pregnancy and until 6 month of post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start10 Sep 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 654 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Réseau de Santé en Périnatalité d'Auvergne, ASM Omnisports - Pôle Sport-Santé, Office Municipal du Sport - Espace Sport Santé, Observatoire national de l'activité physique et de la sédentarité, Ville de Clermont-Ferrand, Ministère de la Santé et de la Prévention
- Responsible party
- Sponsor
- Investigators
- Chloé BARASINSKI, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585085
- Sponsor's protocol ID
- RBHP 2024 BARASINSKI
- Other IDs
- 2024-A00459-38
- Acronym
- PREGMOUV
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathway Organization in Order to Increase Physical Activity Levels and Limit Sedentary Behavior During Pregnancy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06585085
- Acronym / sponsor ID
- PREGMOUV / RBHP 2024 BARASINSKI
- Conditions
- Pregnant Woman
- Keywords
- physical activity, sedentary behaviour, care pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 654 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Réseau de Santé en Périnatalité d'Auvergne, ASM Omnisports - Pôle Sport-Santé, Office Municipal du Sport - Espace Sport Santé, Observatoire national de l'activité physique et de la sédentarité, Ville de Clermont-Ferrand, Ministère de la Santé et de la Prévention
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Sep 2024 (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.
Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA).
Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).
Detailed description
PA has beneficial effects on physical, psychological, and social health, and its regular practice helps to prevent numerous chronic diseases. During pregnancy, PA also has many benefits for women's physical condition, weight gain, gestational hypertension, lower back and pelvic pain, and postpartum depressive symptoms and may also reduce fetal macrosomia and positively affect neurogenesis, language development, memory, and other learning-associated cognitive functions. (CNSF 2021). PA is thus recommended to all pregnant women for 150 to 180 minutes a week, adapted to their health status, physical condition, and course of pregnancy. It is also recommended that women limit their Sedentary Behaviour (SB) (to ≤7 waking h/day) during pregnancy.
No French study has assessed the impact of a PA program during pregnancy, and no published study has proposed videoconference PA sessions during pregnancy. Pregnant women's adherence to PA is a limiting factor found in many interventional studies. Possible changes in maternal behavior in practicing PA and reducing SB during pregnancy could also favorably affect the health of mother and child and thus subsequent PA. Given PA's many benefits and SB's harmful effects during pregnancy, assessing programs that enable pregnant women to both increase PA levels and reduce SB seems pertinent and valuable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - Free PA practice | No intervention | –The women in group A (control group) will receive the usual care provided for any pregnancy, i.e. personalised information on physical activity and sedentary behaviour, with the provision of information booklets. They will be free to exercise during their pregnancy |
| B | Experimental | Behavioral: In person PA sessionsIn-person supervised PA sessions |
| C | Experimental | Behavioral: Interactive videoconference PA sessionsInteractive videoconference PA sessions |
| D | Experimental | Behavioral: In person and by videoconference (mixed format) PA sessions.In person and by videoconference (mixed format) PA sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Pregnant women of more of 18 years and who are being monitored for pregnancy in the Clermont-Ferrand metropolitan area,
- Planned to give birth in a maternity unit localized in Clermont-Ferrand metropolitan area (CHU Estaing or Clinique de la Chataigneraie),
- Agreeing to be randomized, to follow the physical activity program offered in the Clermont-Ferrand metropolitan area, and to follow up as part of the study,
- Able to give informed consent to participate in the research,
- Affiliated to a social security scheme
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| In person PA sessionsGroup B women will have access to a weekly program of 3 face-to-face PA sessions. The face-to-face sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. They will also be offered at one or more times depending on the number of groups. Locations and times will be specified on the online booking software. Women can only register for 3 sessions per week. | Behavioural | B |
| Interactive videoconference PA sessionsWomen in Group C will have access to a weekly program of 3 PA sessions via interactive videoconferencing. These sessions will have the same format as the face-to-face sessions with visualization of the APA professional, visualization of the participants (who can also choose to be masked). The PA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 3 sessions per week. | Behavioural | C |
| In person and by videoconference (mixed format) PA sessions.Women in Group D will have access to a weekly program of 3 mixed-format PA sessions, with 2 interactive distance learning sessions and 1 in-person session. The in-person sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. Locations and times will be specified on the online booking software. Women can only register for 1 face-to-face session per week. The other 2 sessions will be offered via interactive videoconferencing. These sessions will have the same format as the in-person sessions, with visualization of the APA professional, visualization of the participants. The APA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 2 videoconference's sessions per week. | Behavioural | D |
Primary outcome
Women's adherence to PA at the end of the second trimester
Time frame: between 24 and 30 weeks of gestation
measurement of the PA level, measured by accelerometer, expressed in MET.minutes/week by wearing a tri-axial accelerometer on the hip
35 secondary outcomes
women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester
Time frame: between 24 and 30 weeks of gestation
Women's participation at PA sessions
Time frame: After 39 weeks of gestation, end of planned participation in sessions
Pregnancy and Postpartum Evolution of PA Time
Time frame: at 4 distinct times: between 24+0d and 30+0d weeks of gestation, between 32+0d and 37+6d weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum
Evolution in sedentary behavior during pregnancy and postpartum
Time frame: at 4 distinct times: between 24 and 30 weeks of gestation, between 32+0day and 37+6day weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum
Women's perception of the determinants of their level of physical activity and sedentary behaviour
Time frame: during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation
Impact of physical activity on maternal antenatal morbidity
Time frame: At delivery
Impact of sedentary behaviour on maternal antenatal morbidity
Time frame: At delivery
Impact of physical activity on perpartum maternal morbidity
Time frame: 24 hours after delivery
Impact of sedentary behaviour on perpartum maternal morbidity
Time frame: 24 hours after delivery
Impact of physical activity on postpartum maternal morbidity
Time frame: 6 months postpartum
Impact of sedentary behaviour on postpartum maternal morbidity
Time frame: 6 months postpartum
Impact of physical activity on the experience of childbirth
Time frame: 4 weeks postpartum
Impact of sedentary behaviour on the experience of childbirth
Time frame: 4 weeks postpartum
Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
Time frame: between 24 and 30 weeks of gestation
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
Time frame: between 24 and 30 weeks of gestation
Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
Time frame: between 32 and 37 SA+6day weeks of gestation
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
Time frame: between 32 and 37 SA+6day weeks of gestation
Impact of physical activity on the quality of life of pregnant women at 2 months postpartum
Time frame: between 6 and 10 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum
Time frame: between 6 and 10 weeks postpartum
Impact of physical activity on the quality of life of pregnant women at 6 months postpartum
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
Time frame: between 24 and 30 weeks of gestation
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
Time frame: between 24 and 30 weeks of gestation
Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
Time frame: between 32 and 37 SA+6day weeks of gestation
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
Time frame: between 32 and 37 SA+6day weeks of gestation
Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on sexual quality of life
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on sexual quality of life
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on early neonatal morbidity
Time frame: At delivery
Impact of sedentary behaviour on early neonatal morbidity
Time frame: At delivery
Impact of physical activity on the newborn's birth weight
Time frame: At delivery
Impact of sedentary behaviour on the newborn's birth weight
Time frame: At delivery
Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods
Time frame: Data collected during the pregnancy and until 2 month of post-partum
cost-utility study analysis from the point of view of health insurance of the proposed intervention methods
Time frame: Data collected during the pregnancy and until 6 month of post-partum
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Chloé BARASINSKI 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?
A study testing In person PA sessions, Interactive videoconference PA sessions and In person and by videoconference (mixed format) PA sessions. in people with Pregnant Woman, 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 25 inclusion and 0 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 16 Sep 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 (+33473754963, 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?
Women's adherence to PA at the end of the second trimester (time frame: between 24 and 30 weeks of gestation). 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 16 Sep 2026.