Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
300

Summary

Conditions
  • Maternal-Fetal Relations
  • Pregnancy Related
  • Pregnant Women
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The present study will involve two study groups. Exercise group (EG). Pregnant women allocated in the EG will receive and intervention based on a supervised antenatal physical activity programme during 20-24 weeks. They must be enrolled in the study between their 12-16 weeks of gestation. Control group (CG). Pregnant women allocated in CG will not receive any intervention. They will maintain standard health care during pregnancy. Masking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only males

Description

Overwhelming research supports the general benefit of antenatal physical activity (APA) for pregnant women, but there is a lack of knowledge about the influence of exercise on cardiovascular physiology in healthy and overweight pregnant women and their foetuses. Also some research supports the theor...

Overwhelming research supports the general benefit of antenatal physical activity (APA) for pregnant women, but there is a lack of knowledge about the influence of exercise on cardiovascular physiology in healthy and overweight pregnant women and their foetuses. Also some research supports the theory of foetal programming; which establish that maternal habits during pregnancy will impact in-utero environment, so if this maternal habits are healthy ones they could improve foetal health. Cardio vascular disease (CVD) was the top cause of death all over the world in 2015. In Wales CVD as cause of death is still one of the top ones. However, these statistics could be improved if people adopt healthier lifestyle habits, since 54% and 45% of Welsh women are overweight/obese or sedentary respectively. Pregnancy seems to be a teachable moment for women and the starting point of adopting healthy life-style habits. Therefore, by introducing Welsh pregnant women to exercise, there is the potential to improve their health and of their foetuses an also exert an exponential impact on future generations. The main theme of this study focuses on providing evidence of the impact of APA on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period. This is a 3-year study carried out in Swansea University, Singleton Hospital. The project leading to this application has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 663830. Healthy pregnant women with no contraindications for exercise will be eligible for the study and those who want to participate in the project will be allocated into an exercise group (EG) or a control group (CG). EG participants will receive an intervention based on an APA during 20-24weeks, CG participants will follow their standard health care during pregnancy. All participants must attend three cardiovascular assessment protocols (18-22 weeks & 32-36weeks during pregnancy, 12weeks postpartum). These protocols will involve maternal/foetal electrocardiograph and echocardiograph evaluation, heart-rate monitoring and moderate physical exercise (walking).

Tracking Information

NCT #
NCT03748888
Collaborators
European Union
Investigators
Study Chair: MICHAEL J LEWIS, Prof Swansea University