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Clinical Trials/NCT03748888
NCT03748888
Completed
Not Applicable

Physical Exercise, Cardiovascular Adaptation Monitoring in Pregnancy

Swansea University1 site in 1 country138 target enrollmentApril 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Swansea University
Enrollment
138
Locations
1
Primary Endpoint
Changes in maternal cardiac output during and after pregnancy.
Status
Completed
Last Updated
3 years ago

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. 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).

Registry
clinicaltrials.gov
Start Date
April 26, 2018
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Olga Roldan-Reoyo

Principal Investigator

Swansea University

Eligibility Criteria

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.)

Study Sites (1)

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