Pregnancy RelatedNCT06572943
The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
A study testing Moderate intensity physical activity in people with Pregnancy Related, run by George Makrydimas at 1 site in Greece.
Trial summary
The investigators aim to evaluate the effect of long-term moderate intensity physical activity during pregnancy in maternal and fetal cardiovascular system. A randomized clinical trial was designed with two groups (Study group and Control Group). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Moderate intensity physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 26 Aug 2024to 1 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women during 1st trimester, who had the routine dating scan at 11-13+6 gestational weeks [also known as Nuchal translucency (NT) scan] and the uterine arteries (UtA) PI assessment
Who cannot join
- Diabetes Mellitus (Type I or II)
- Maternal age < 18 years old
- Body Mass Index (BMI) > 40
- Contraindications for PA: Multiple Pregnancies, Vaginal Bleeding, Hypertension or Gestational Hypertension, Uncontrolled Thyroid Diseases, Cardiovascular Diseases (e.g. valvular diseases, congenital heart diseases, cardiomyopathies, atrial fibrillation, coronary heart disease) or respiratory system diseases (asthma, chronic obstructive pulmonary disease) or systemic disease (cancer, autoimmune diseases) or several other diseases considered to be barriers for PA during pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University Hospital of Ioannina
Ioannina, 45500
George Makrydimas, Professor, +30 6944542420, gmakrydi@uoi.gr
About this study
The investigators aim to evaluate the effect of long-term moderate intensity physical activity during pregnancy in maternal and fetal cardiovascular system. A randomized clinical trial was designed with two groups (Study group and Control Group).
Read the detailed description
Physical activity (PA) enhances not only physical but also mental health.PA contributes to the prevention of a variety of diseases in general population including hypertension, diabetes mellitus, stress, and depression. Nevertheless, pregnancy is a time period that various changes take place in a woman's body. Those alterations might be either facilitators or barriers for conducting PA during pregnancy.
When it comes to pregnancy several benefits have been associated with PA for both mother and fetus; such as low gestational weight gain, lower incidence of gestational diabetes mellitus (GDM), better management of Pre-eclampsia and post-partum weight retention. Moreover, PA improves mental health in pregnant women, while recent studies have revealed that physical exercise during pregnancy can improve oxidative stress, inflammation and endothelial function. The vast majority of Obstetricians \& Gynecologists recommend that pregnant women should be urged to start or continue doing physical activity in the absence of contraindications. To be more specific, pregnant women should do at least 150 minutes of moderate intensity PA weekly. However, several studies support that pregnant women all over the world does not meet those recommendations. Relevant evidence of published literature are scarce regarding the alterations on maternal and fetal cardiovascular system due to chronic exercise .
Thus, investigators aim to evaluate the effect of long-term moderate intensity PA in maternal and fetal cardiovascular system. Thus, a randomized clinical trial with two groups (study group-control group) was designed. The study group includes pregnant women during the 1st trimester that will undergo moderate intensity PA, while the control group includes pregnant women that will receive the routine antenatal care. Participants will be followed up until 6 months postpartum.
To be more specific, all participants will receive a pedometer to record their daily steps from the first trimester until the postpartum period. The intervention group will additional receive detailed recommendations for 30 minutes of moderate intensity exercise at least 4-5 times per week (if not daily) and brochures with relevant information will be administrated as well. Moreover, brochures with dietary recommendations during pregnancy will be given to all participants.
Three routine antenatal ultrasound scans at 11-13+6 , 20-24, and 32-36 gestational weeks will be performed. Maternal Uterine Dopplers will be assessed at every scan, while fetal Dopplers will be done at 2nd and 3rd trimester. Maternal cardiovascular assessment will take place at 1st trimester, 3rd trimester and postpartum with transthoracic echocardiography, ophthalmic artery Doppler, Flow Mediated Dilatation and Arterial Stiffness . Fetal heart function will be assessed at 2nd and 3rd trimester. Evaluation of the infants' heart will also be performed at 6 months postpartum. A questionnaire evaluating mental health known as Depression-Anxiety and Stress Scale 21 (DASS-21) in pregnant women will be administered during the 1st and 3rd trimester. Maternal body fat measurements will take place at each trimester and postpartum. In addition fat composition of both the fetus will be evaluated by ultrasound before the delivery and the newborn within 48 hours following birth. Maternal blood sample will be collected during 1st trimester, 3rd trimester and postpartum and blood sample from the umbilical cord during labour, to assess several parameters.
All participants will be fully informed about the purpose of the study and will be included only after signing the Informed Consent Form. All data collected will be confidential and only accessible to members of the research team. These data will be coded according to GDPR. The clinical implementation of this study will be according to the International Code of Medical Ethics of the World Medical Association (Declaration of Helsinki), and all participants submitted a written informed consent since a detailed description of all aspects and the objectives of the study are explained and fully understood. The ethical committee of the University Hospital of Ioannina approved this study (decision number: 3/30-01-2024; date of approval; 30 January 2024).
- Conditions
- Pregnancy Related
- Being tested
- Moderate intensity physical activity
- Keywords
- pregnancy, physical activity, exercise, Maternal cardiovascular system, Fetal cardiovascular system
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity physical activityOther
Moderate intensity exercise of 30 minutes for at least 4-5 times per week (if not daily).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine Antenatal Care. Brochures with dietary recommendations will be given. |
| Experimental | Experimental | Detailed recommendations and brochures regarding physical activity will be given.Moreover brochures with dietary recommendations will be administrated. Receives: Other: Moderate intensity physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Arteries Pulsatility Index at each trimester
Uterine Arteries Pulsatility Index will be measured with Ultrasound Doppler by the same operator, at each trimester
Measured: 11-13+6, 20-24, and 32-36 gestational weeks
Secondary outcomes (14)
Umbilical artery Pulsatility Index during the 2nd and 3rd trimester
Measured with Ultrasound Doppler by the same operator
Measured: 20-24, and 32-36 gestational weeks
Middle Cerebral Artery Pulsatility Index during the 2nd and 3rd trimester
Measured with Ultrasound Doppler by the same operator
Measured: 20-24, and 32-36 gestational weeks
Incidence of Gestational Diabetes
Diagnosis will be made based on oral glucose tolerance test with ingestion of 75g of glucose. Abnormal is considered either of the following: fasting glucose >92mg/dl, glucose >180mg/dl one hour after, glucose >153mg/dL two hours after.
Measured: 26-29 weeks gestation
Incidence Pre-eclampsia
New onset of hypertension and proteinuria or the new onset of hypertension plus significant end-organ dysfunction with or without proteinuria
Measured: >20 weeks until 4-6 weeks postpartum
Maternal body fat measurements
Measured with calibrated body fat scale
Measured: 11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum
Gestational weight Change
Comparison of maternal weight at the time of inclusion in the study and at the final ultrasound examination.
Measured: Between 36-40 weeks gestation
Gestational age at labor
Gestational weeks
Measured: Delivery
Maternal mental health
Depression-Anxiety and Stress Scale 21. This scale is a 21 item self report questionnaire designed to measure the severity of a range of symptoms common ot both Depression and Anxiety. Each item is scored from 0 (did not apply to me) to 3(applied to me very much or most of the time). The scale ot which each item belongs is indicated by the letters D(Depression), A(Anxiety) and S (Stress). For each scale (D, A\&S) sum the scores for identified items. The higher scores indicate more severe conditions.
Measured: 11-13+6. and 32-36 gestational weeks
Maternal cardiovascular adaptations during pregnancy and postpartum
Transthoracic echocardiography will be performed by specialist cardiologist and will assess the following parameters: PWV, cSBP, cPP, LVEF, LVEDd, LVM, GLS, EDV, ESV, LAV, LAVI, MPI, LVMI, IVS, VTI, TR, PWT, RWT, E wave velοcity, A wave velocity, Deceleration time E/A ratio, Lateral e' velocity, Septal e' velocity
Measured: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Arterial stiffness and FMD adaptations thorough pregnancy
: Arterial Stiffness will be evaluated using the Mobil-O-Graph tool as assessed by the Pulse wave Velocity (PWV). FMD represents a non-invasive method to determine the endothelial dysfunction in the brachial artery in response to reactive hyperaemia.
Measured: 11-13+6. and 32-36 gestational weeks and 8-12 weeks postpartum
Maternal Blood Samples' findings
: Maternal blood samples will be analyzed by certified laboratories and the findings will be evaluated. Comparisons between the two groups will take place.
Measured: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Umbilical cord blood samples; findings
Umbilical cord blood samples will be analyzed by certified laboratories and the findings will be evaluated. Comparisons between the two groups will take place
Measured: Delivery
Fetus and Neonatal Fat Composition
Fat composition of the neonate will be measured with ultrasound at the level of femur, humerus abdomen and scapula. Comparisons between the two groups will take place
Measured: Before delivery and within 48 hours following delivery
Fetal heart adaptations and cardiovascular changes of the infant
The following parameters were obtained via fetal echocardiography during ultrasound examinations at 20-24 and 32-36 gestational weeks as well as transthoracic echocardiography of the infant at 5-7 months old: MAPSE, TAPSE, LVCO, LVEF, E/A ratio, AoI PI, DA PI, Aorta peak velocity, Pulmonary Artery peak Velocity. A comparison between the two groups (study group-control group) will be conducted, as well.
Measured: 20-24, 32-36 gestational weeks and 5-7 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start26 Aug 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Makrydimas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, George Makrydimas, University Hospital, Ioannina
- Investigators
- George Makrydimas, Professor, Study director, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572943
- Sponsor's protocol ID
- 3/30-01-2024 (θ. 6)
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martland R, Mondelli V, Gaughran F, Stubbs B. Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. J Sports Sci. 2020 Feb;38(4):430-469. doi: 10.1080/02640414.2019.1706829. Epub 2019 Dec 31.
PubMed 31889469Zschucke E, Gaudlitz K, Strohle A. Exercise and physical activity in mental disorders: clinical and experimental evidence. J Prev Med Public Health. 2013 Jan;46 Suppl 1(Suppl 1):S12-21. doi: 10.3961/jpmph.2013.46.S.S12. Epub 2013 Jan 30.
PubMed 23412549Davies G, Artal R. It's time to treat exercise in pregnancy as therapy. Br J Sports Med. 2019 Jan;53(2):81. doi: 10.1136/bjsports-2018-100360. Epub 2018 Dec 15. No abstract available.
PubMed 30554145Michalek IM, Comte C, Desseauve D. Impact of maternal physical activity during an uncomplicated pregnancy on fetal and neonatal well-being parameters: a systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:265-272. doi: 10.1016/j.ejogrb.2020.06.061. Epub 2020 Jun 29.
PubMed 32634674Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.
PubMed 32217980Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.
PubMed 30337460Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and sedentary behavior among US pregnant women. Prev Med. 2011 Jul-Aug;53(1-2):39-43. doi: 10.1016/j.ypmed.2011.04.014. Epub 2011 May 4.
PubMed 21575654Hesketh KR, Evenson KR. Prevalence of U.S. Pregnant Women Meeting 2015 ACOG Physical Activity Guidelines. Am J Prev Med. 2016 Sep;51(3):e87-9. doi: 10.1016/j.amepre.2016.05.023. No abstract available.
PubMed 27544437Fernandez-Buhigas I, Martin Arias A, Vargas-Terrones M, Brik M, Rolle V, Barakat R, Munoz-Gonzalez MD, Refoyo I, Gil MM, Santacruz B. Fetal and maternal Doppler adaptation to maternal exercise during pregnancy: a randomized controlled trial. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183759. doi: 10.1080/14767058.2023.2183759.
PubMed 36889747Chatzakis C, Sotiriadis A, Fatouros IG, Jamurtas AZ, Deli CK, Papagianni M, Dinas K, Mastorakos G. The Effect of Physical Exercise on Oxidation Capacity and Utero-Placental Circulation in Pregnancies with Gestational Diabetes Mellitus and Uncomplicated Pregnancies, a Pilot Study. Diagnostics (Basel). 2022 Jul 16;12(7):1732. doi: 10.3390/diagnostics12071732.
PubMed 35885635
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
- ClinicalTrials.gov ID
- NCT06572943
- Acronym / sponsor ID
- 3/30-01-2024 (θ. 6)
- Conditions
- Pregnancy Related
- Keywords
- pregnancy, physical activity, exercise, Maternal cardiovascular system, Fetal cardiovascular system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- George MakrydimasUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Aug 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.
The investigators aim to evaluate the effect of long-term moderate intensity physical activity during pregnancy in maternal and fetal cardiovascular system. A randomized clinical trial was designed with two groups (Study group and Control Group).
Detailed description
Physical activity (PA) enhances not only physical but also mental health.PA contributes to the prevention of a variety of diseases in general population including hypertension, diabetes mellitus, stress, and depression. Nevertheless, pregnancy is a time period that various changes take place in a woman's body. Those alterations might be either facilitators or barriers for conducting PA during pregnancy.
When it comes to pregnancy several benefits have been associated with PA for both mother and fetus; such as low gestational weight gain, lower incidence of gestational diabetes mellitus (GDM), better management of Pre-eclampsia and post-partum weight retention. Moreover, PA improves mental health in pregnant women, while recent studies have revealed that physical exercise during pregnancy can improve oxidative stress, inflammation and endothelial function. The vast majority of Obstetricians \& Gynecologists recommend that pregnant women should be urged to start or continue doing physical activity in the absence of contraindications. To be more specific, pregnant women should do at least 150 minutes of moderate intensity PA weekly. However, several studies support that pregnant women all over the world does not meet those recommendations. Relevant evidence of published literature are scarce regarding the alterations on maternal and fetal cardiovascular system due to chronic exercise .
Thus, investigators aim to evaluate the effect of long-term moderate intensity PA in maternal and fetal cardiovascular system. Thus, a randomized clinical trial with two groups (study group-control group) was designed. The study group includes pregnant women during the 1st trimester that will undergo moderate intensity PA, while the control group includes pregnant women that will receive the routine antenatal care. Participants will be followed up until 6 months postpartum.
To be more specific, all participants will receive a pedometer to record their daily steps from the first trimester until the postpartum period. The intervention group will additional receive detailed recommendations for 30 minutes of moderate intensity exercise at least 4-5 times per week (if not daily) and brochures with relevant information will be administrated as well. Moreover, brochures with dietary recommendations during pregnancy will be given to all participants.
Three routine antenatal ultrasound scans at 11-13+6 , 20-24, and 32-36 gestational weeks will be performed. Maternal Uterine Dopplers will be assessed at every scan, while fetal Dopplers will be done at 2nd and 3rd trimester. Maternal cardiovascular assessment will take place at 1st trimester, 3rd trimester and postpartum with transthoracic echocardiography, ophthalmic artery Doppler, Flow Mediated Dilatation and Arterial Stiffness . Fetal heart function will be assessed at 2nd and 3rd trimester. Evaluation of the infants' heart will also be performed at 6 months postpartum. A questionnaire evaluating mental health known as Depression-Anxiety and Stress Scale 21 (DASS-21) in pregnant women will be administered during the 1st and 3rd trimester. Maternal body fat measurements will take place at each trimester and postpartum. In addition fat composition of both the fetus will be evaluated by ultrasound before the delivery and the newborn within 48 hours following birth. Maternal blood sample will be collected during 1st trimester, 3rd trimester and postpartum and blood sample from the umbilical cord during labour, to assess several parameters.
All participants will be fully informed about the purpose of the study and will be included only after signing the Informed Consent Form. All data collected will be confidential and only accessible to members of the research team. These data will be coded according to GDPR. The clinical implementation of this study will be according to the International Code of Medical Ethics of the World Medical Association (Declaration of Helsinki), and all participants submitted a written informed consent since a detailed description of all aspects and the objectives of the study are explained and fully understood. The ethical committee of the University Hospital of Ioannina approved this study (decision number: 3/30-01-2024; date of approval; 30 January 2024).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine Antenatal Care. Brochures with dietary recommendations will be given. |
| Experimental | Experimental | Other: Moderate intensity physical activityDetailed recommendations and brochures regarding physical activity will be given.Moreover brochures with dietary recommendations will be administrated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women during 1st trimester, who had the routine dating scan at 11-13+6 gestational weeks [also known as Nuchal translucency (NT) scan] and the uterine arteries (UtA) PI assessment
Key exclusion criteria (4 listed)
- Diabetes Mellitus (Type I or II)
- Maternal age < 18 years old
- Body Mass Index (BMI) > 40
- Contraindications for PA: Multiple Pregnancies, Vaginal Bleeding, Hypertension or Gestational Hypertension, Uncontrolled Thyroid Diseases, Cardiovascular Diseases (e.g. valvular diseases, congenital heart diseases, cardiomyopathies, atrial fibrillation, coronary heart disease) or respiratory system diseases (asthma, chronic obstructive pulmonary disease) or systemic disease (cancer, autoimmune diseases) or several other diseases considered to be barriers for PA during pregnancy.
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 |
|---|---|---|
| Moderate intensity physical activityModerate intensity exercise of 30 minutes for at least 4-5 times per week (if not daily). | Other | Experimental |
Primary outcome
Uterine Arteries Pulsatility Index at each trimester
Time frame: 11-13+6, 20-24, and 32-36 gestational weeks
Uterine Arteries Pulsatility Index will be measured with Ultrasound Doppler by the same operator, at each trimester
14 secondary outcomes
Umbilical artery Pulsatility Index during the 2nd and 3rd trimester
Time frame: 20-24, and 32-36 gestational weeks
Middle Cerebral Artery Pulsatility Index during the 2nd and 3rd trimester
Time frame: 20-24, and 32-36 gestational weeks
Incidence of Gestational Diabetes
Time frame: 26-29 weeks gestation
Incidence Pre-eclampsia
Time frame: >20 weeks until 4-6 weeks postpartum
Maternal body fat measurements
Time frame: 11-13+6., 20-24, and 32-36 gestational weeks, 8-12 weeks postpartum
Gestational weight Change
Time frame: Between 36-40 weeks gestation
Gestational age at labor
Time frame: Delivery
Maternal mental health
Time frame: 11-13+6. and 32-36 gestational weeks
Maternal cardiovascular adaptations during pregnancy and postpartum
Time frame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Arterial stiffness and FMD adaptations thorough pregnancy
Time frame: 11-13+6. and 32-36 gestational weeks and 8-12 weeks postpartum
Maternal Blood Samples' findings
Time frame: 11-13+6, 32-36 gestational weeks and 8-12 weeks postpartum
Umbilical cord blood samples; findings
Time frame: Delivery
Fetus and Neonatal Fat Composition
Time frame: Before delivery and within 48 hours following delivery
Fetal heart adaptations and cardiovascular changes of the infant
Time frame: 20-24, 32-36 gestational weeks and 5-7 months postpartum.
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 11 Dec 2024.
- Background: PubMed 31889469Martland R, Mondelli V, Gaughran F, Stubbs B. Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. J Sports Sci. 2020 Feb;38(4):430-469. doi: 10.1080/02640414.2019.1706829. Epub 2019 Dec 31.
- Background: PubMed 23412549Zschucke E, Gaudlitz K, Strohle A. Exercise and physical activity in mental disorders: clinical and experimental evidence. J Prev Med Public Health. 2013 Jan;46 Suppl 1(Suppl 1):S12-21. doi: 10.3961/jpmph.2013.46.S.S12. Epub 2013 Jan 30.
- Background: PubMed 30554145Davies G, Artal R. It's time to treat exercise in pregnancy as therapy. Br J Sports Med. 2019 Jan;53(2):81. doi: 10.1136/bjsports-2018-100360. Epub 2018 Dec 15. No abstract available.
- Background: PubMed 32634674Michalek IM, Comte C, Desseauve D. Impact of maternal physical activity during an uncomplicated pregnancy on fetal and neonatal well-being parameters: a systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:265-272. doi: 10.1016/j.ejogrb.2020.06.061. Epub 2020 Jun 29.
- Background: PubMed 32217980Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.
- Background: PubMed 30337460Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.
- Background: PubMed 21575654Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and sedentary behavior among US pregnant women. Prev Med. 2011 Jul-Aug;53(1-2):39-43. doi: 10.1016/j.ypmed.2011.04.014. Epub 2011 May 4.
- Background: PubMed 27544437Hesketh KR, Evenson KR. Prevalence of U.S. Pregnant Women Meeting 2015 ACOG Physical Activity Guidelines. Am J Prev Med. 2016 Sep;51(3):e87-9. doi: 10.1016/j.amepre.2016.05.023. No abstract available.
- Background: PubMed 36889747Fernandez-Buhigas I, Martin Arias A, Vargas-Terrones M, Brik M, Rolle V, Barakat R, Munoz-Gonzalez MD, Refoyo I, Gil MM, Santacruz B. Fetal and maternal Doppler adaptation to maternal exercise during pregnancy: a randomized controlled trial. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2183759. doi: 10.1080/14767058.2023.2183759.
- Background: PubMed 35885635Chatzakis C, Sotiriadis A, Fatouros IG, Jamurtas AZ, Deli CK, Papagianni M, Dinas K, Mastorakos G. The Effect of Physical Exercise on Oxidation Capacity and Utero-Placental Circulation in Pregnancies with Gestational Diabetes Mellitus and Uncomplicated Pregnancies, a Pilot Study. Diagnostics (Basel). 2022 Jul 16;12(7):1732. doi: 10.3390/diagnostics12071732.
- Exercise in PregnancyLink provided by the sponsor.
- Physical activity and pregnancy. RCOGLink provided by the sponsor.
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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.
George Makrydimas, Professor study director
University Hospital, Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity physical activity in people with Pregnancy Related, run by George Makrydimas at 1 site in Greece.
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 4 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 11 Dec 2024. 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 Greece. 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 George Makrydimas, Professor (+306944542420, grmak@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Arteries Pulsatility Index at each trimester (time frame: 11-13+6, 20-24, and 32-36 gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572943, which also lists 10 linked publications.
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 11 Dec 2024.