Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572943
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Physical activity PA enhances not only physical but also mental healthPA 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 womans 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 11-136 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 330-01-2024 date of approval 30 January 2024
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 11-136 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 330-01-2024 date of approval 30 January 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None