Physical Exercise, Cardiovascular Adaptation Monitoring in Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Swansea University
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Changes in maternal cardiac output during and after pregnancy.
Study Overview
Brief Summary
The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.
Detailed 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women with healthy pregnancy
- •Aged 18-40 years
- •Single pregnancy
- •Pregnancy stage <= 16 weeks' gestation at the point of consent.
- •Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).
Exclusion Criteria
- •Known complications of pregnancy
- •Known contraindications for physical exercise
- •Known major cardiovascular or respiratory pathology
- •Three or more previous term pregnancies
- •Inability to communicate in English or Welsh.
Outcomes
Primary Outcomes
Changes in maternal cardiac output during and after pregnancy.
Time Frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal cardiac output at rest, during exercise and after exercise measured in L/min would be recorded from study participants to analyse and compare potential changes inter and intra group.
Changes in maternal heart rate during and after pregnancy.
Time Frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal heart rate at rest and after exercise would be recorded in beats per minute to be analysed and compared inter and intra group.
Foetal heart rate
Time Frame: 36 weeks pregnancy
Foetal heart rate baseline would be measured at rest, during and after exercise. It would be analysed and compared in between groups.
Changes in maternal heart rate variability during and after pregnancy
Time Frame: 18 and 36 weeks of gestation, 12 weeks postpartum.
Maternal heart rate variability at rest, during and after exercise would be measured by r to r interval. It would be recorded and analysed to compare inter and intra group changes.
Secondary Outcomes
- Changes in active pregnant women energy expenditure(18 and 36 weeks pregnancy.)
- Changes in sedentary pregnant women energy expenditure(18 and 36 weeks pregnancy.)
- Energy expenditure during the early postpartum period.(12 weeks postpartum.)
- Gestational weight gain.(36 weeks pregnancy.)
- Changes in maternal body fat percentage during pregnancy.(18 and 36 weeks pregnancy.)
- Birth weight(Second week after birth.)
- Results from Qol-Grav questionnaire during second and third trimester of pregnancy.(18 and 36 weeks pregnancy.)
- Pre-pregnancy physical activity levels recorded by the modified physical activity questionnaire.(12 weeks pregnancy.)
- Changes in quality of sleep during pregnancy.(18 and 36 weeks of pregnancy.)
- Sleep patterns in the three months old infant(12 weeks postpartum.)
- Pregnancy physical activity levels during first trimester recorded by the modified physical activity questionnaire.(12 weeks pregnancy.)
- Pregnancy physical activity levels during second and third trimester recorded by the modified physical activity questionnaire.(36 weeks pregnancy.)
- Quality of sleep during postpartum.(12 weeks postpartum.)
Investigators
Olga Roldan-Reoyo
Principal Investigator
Swansea University