Clinical trial NCT03748888: Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)
Official title: Physical Exercise, Cardiovascular Adaptation Monitoring in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Pregnant Women
Maternal-Fetal Relations
Keywords: Cardiovascular system
Antenatal physical activity
Maternal heart rate
Foetal heart rate
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2018-11-21
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will involve two study groups.

1. 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.
2. Control group (CG). Pregnant women allocated in CG will not receive any intervention. They will maintain standard health care during pregnancy.
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in maternal cardiac output during and after pregnancy.
timeFrame: 18 and 36 weeks of gestation, 12 weeks postpartum.
measure: Changes in maternal heart rate during and after pregnancy.
timeFrame: 18 and 36 weeks of gestation, 12 weeks postpartum.
measure: Changes in maternal heart rate variability during and after pregnancy
timeFrame: 18 and 36 weeks of gestation, 12 weeks postpartum.
measure: Foetal heart rate
timeFrame: 36 weeks pregnancy
Secondary outcomes:
measure: Changes in active pregnant women energy expenditure
timeFrame: 18 and 36 weeks pregnancy.
measure: Changes in sedentary pregnant women energy expenditure
timeFrame: 18 and 36 weeks pregnancy.
measure: Energy expenditure during the early postpartum period.
timeFrame: 12 weeks postpartum.
measure: Gestational weight gain.
timeFrame: 36 weeks pregnancy.
measure: Changes in maternal body fat percentage during pregnancy.
timeFrame: 18 and 36 weeks pregnancy.
measure: Birth weight
timeFrame: Second week after birth.
measure: Results from Qol-Grav questionnaire during second and third trimester of pregnancy.
timeFrame: 18 and 36 weeks pregnancy.
measure: Pre-pregnancy physical activity levels recorded by the modified physical activity questionnaire.
timeFrame: 12 weeks pregnancy.
measure: Pregnancy physical activity levels during first trimester recorded by the modified physical activity questionnaire.
timeFrame: 12 weeks pregnancy.
measure: Pregnancy physical activity levels during second and third trimester recorded by the modified physical activity questionnaire.
timeFrame: 36 weeks pregnancy.
measure: Changes in quality of sleep during pregnancy.
timeFrame: 18 and 36 weeks of pregnancy.
measure: Quality of sleep during postpartum.
timeFrame: 12 weeks postpartum.
measure: Sleep patterns in the three months old infant
timeFrame: 12 weeks postpartum.
Other outcomes:
measure: Type of birth.
timeFrame: 2 weeks postpartum.
measure: Type of analgesia used during labour
timeFrame: 2 weeks postpartum.
measure: New born's Apgar score
timeFrame: 2 weeks postpartum.
measure: Changes in maternal hand grip strength during pregnancy.
timeFrame: 18 and 36 weeks of pregnancy.
measure: Maternal hand grip strength during postpartum.
timeFrame: 12 weeks postpartum.
measure: Changes in maternal upper body range of motion during pregnancy.
timeFrame: 18 and 36 weeks of pregnancy.
measure: Maternal upper body range of motion during postpartum.
timeFrame: 12 weeks postpartum.
Locations:
city: Swansea
country: United Kingdom
facility: Singleton Hospital, Maternity Unit
Study officials:
affiliation: Swansea University
name: MICHAEL J LEWIS, Prof
role: STUDY_CHAIR
References:
citation: Carpenter RE, Emery SJ, Uzun O, Rassi D, Lewis MJ. Influence of physical exercise on baroreceptor sensitivity during pregnancy. J Matern Fetal Neonatal Med. 2017 Mar;30(5):514-519. doi: 10.1080/14767058.2016.1179275. Epub 2016 May 12.
citation: Carpenter RE, D'Silva LA, Emery SJ, Uzun O, Rassi D, Lewis MJ. Changes in heart rate variability and QT variability during the first trimester of pregnancy. Physiol Meas. 2015 Mar;36(3):531-45. doi: 10.1088/0967-3334/36/3/531. Epub 2015 Feb 18.