Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)

Swansea University

Status: Completed

Conditions: Pregnant Women; Pregnancy Related; Maternal-Fetal Relations

Treatments: Behavioral: Exercise group

Study type: Interventional

Funder types: Other

Identifiers

NCT03748888

663830-SU-079

17/WA/0414 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

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).

Enrollment: 138 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women with healthy pregnancy
2. Aged 18-40 years
3. Single pregnancy
4. Pregnancy stage <= 16 weeks' gestation at the point of consent.
5. Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).

Exclusion criteria

1. Known complications of pregnancy
2. Known contraindications for physical exercise
3. Known major cardiovascular or respiratory pathology
4. Three or more previous term pregnancies
5. Inability to communicate in English or Welsh.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Exercise group

Experimental group

Description:

An antenatal physical activity (APA) programme will be designed for participants in the exercise group.

Treatment:

Behavioral: Exercise group

Control Group

No Intervention group

Description:

Sedentary participants.