The Effect of Long-Term Moderate Intensity Exercise During Pregnancy on Maternal and Fetal Cardiovascular System
NCT Number: NCT06572943
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Related
Interventions: OTHER: Moderate intensity physical activity
Sponsor: George Makrydimas
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-26
Completion Date: 2026-09-01

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).

Primary Outcome Measures: Uterine Arteries Pulsatility Index at each trimester, Uterine Arteries Pulsatility Index will be measured with Ultrasound Doppler by the same operator, at each trimester, 11-13+6, 20-24, and 32-36 gestational weeks
Secondary Outcome Measures: Umbilical artery Pulsatility Index during the 2nd and 3rd trimester, Measured with Ultrasound Doppler by the same operator, 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, 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., 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, >20 weeks until 4-6 weeks postpartum|Maternal body fat measurements, Measured with calibrated body fat scale, 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., Between 36-40 weeks gestation|Gestational age at labor, Gestational weeks, 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., 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, 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., 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., 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, 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, 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., 20-24, 32-36 gestational weeks and 5-7 months postpartum.