None listed
Conditions
Brief summary
This international multicentre prospective observational study, performed at the Royal Women’s Hospital, Melbourne, Australia, and Chelsea & Westminster Hospital, London, UK, and Mowbray Maternity Hospital, Cape Town, South Africa aims to determine the reference range for an exercise test, the six minute walk test, in healthy pregnant women and non-pregnant women of childbearing age. This test is commonly used in non-pregnant adults to determine cardiovascular fitness and as a prognostic test in adults with chronic medical conditions. Its utility has not been investigated in pregnant women. It is hoped that this study will provide the baseline data for further studies investigating the usefulness of this test in pregnant women and non-pregnant women of childbearing age. Specifically, the use of this test to predict women who will develop new onset hypertension in pregnancy, the use of this test as part of a pre-pregnancy exercise intervention program to reduce the likelihood of developing new onset hypertension in pregnancy, and the use of the test to quantify symptoms of fatigue and breathlessness in pregnancy. As part of this study 30 pregnant women in second trimester will undergoing three additional test - the incremental shuttle walk test, cardiopulmonary exercise testing and transthoracic echocardiography. The reason to do this is to determine the relationship between submaximal exercise testing with exercise tests (The Six Minute Walk Test - an unpaced test, and the Incremental Shuttle Walk Test - a paced test) and cardiac function with echocardiography and direct measurement of maximal oxygen utilisation capacity with the cardiopulmonary exercise testing.
Interventions
The Six Minute Walk (6MWT) Test, conducted as specified by the National Heart Foundation of Australia, with two walk tests performed and this should take a maximum of 30 min to complete including the breaks.
The Incremental Shuttle Walk Test conducted as specified by "Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J 2014;44:1428-46." This test will ta
The Six Minute Walk (6MWT) Test, conducted as specified by the National Heart Foundation of Australia, with two walk tests performed and this should take a maximum of 30 min to complete including the breaks. The Incremental Shuttle Walk Test conducted as specified by "Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J 2014;44:1428-46." This test will take approximately 30 minutes and be conducted one-on-one by one of the trained research investigators (including a physiotherapist or trained research midwife). Transthoracic echocardiography according to guidelines by the American Society of Echocardiography. This test will take approximately 15 minutes and be conducted one-on-one by one of the trained research investigators (including a trained obstetric anaesthetist (TTE trained) or cardiac sonographer). Cardiopulmonary exercise testing (CPET) according to accepted guidelines "American Thoracic S, American College of Chest P. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med 2003;167:211-77." This test will take approximately 1 hour and will be conducted using a stationary bicycle (cycle ergometer), one-on-one with the trained research and clinical team at Peter MacCallum Hospital. Testing will occur over two separate days and will be conducted in women in the early pregnancy group of participants in the 6MWT study (healthy nulliparous pregnant women approximately less than 24 weeks gestation, no musculoskeletal problems, no pelvic floor problems – all outpatients). The two testing days are to occur within a seven-day period. On the first testing day participants will complete three of four tests. Day One: Resting echocardiography – Royal Women’s Hospital The Minute Walk Test (6MWT) - Royal Women’s Hospital Cardiopulmonary Exercise Testing (CPEP) – Peter MacCallum Cancer Centre Day Two: Perform the Incremental Shuttle walk Test (ISWT) – Royal Women’s Hospital Selection of participants Testing will be conducted in women in the early pregnancy group of participants in the 6MWT study (healthy nulliparous pregnant women approximately less than 24 weeks gestation, no musculoskeletal problems, no pelvic floor problems – all outpatients). Therefore, we will recruit women from this group of participants. A convenience sample of 100 clinicians (obstetricians, obstetric trainees and midwifes) will be invited to participate in a questionnaire regarding the assessment and management of breathlessness and exertion in pregnant women (a scenario will be presented of a hypothetical primaparous woman at 30 weeks’ gestation). Objective scales - modified Borg Dyspnoea Scale (BDS) and the rating of Perceived exertion scale (RPE) will be used to numerically score clinicians grading of breathlessness and exertion.
Sponsors
The Royal Women's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy pregnant nulliparous women will be defined as American Society of Anesthesiologists (ASA) Classification I or II, with no significant medical or surgical illnesses, and aged 18 - 40 years. Second trimester women will be recruited from 140 to 236 weeks gestation. Term pregnant women will be recruitment from 360 weeks gestation until delivery. Healthy non-pregnant nulliparous women will be defined as American Society of Anesthesiologists (ASA) Classification I or II, with no significant medical or surgical illnesses, and aged 18 - 40 years. a. Women less than 24 weeks pregnant will be included if body mass index is less than or equal to 32 kg/m2 at the time of the study b. Women equal to or greater than 36 weeks pregnant will be included if body mass index is less than 35 kg/m2 at the time of the study c. Non-pregnant women will be included if body mass index is equal to or less than 30 kg/m2 at the time of the study
Exclusion criteria
Any woman with pre-existing conditions that limit ability to exercise (joint, muscle, bone, neurological), pre-existing or gestational diabetes, pre-existing or pregnancy acquired cardiovascular disease, multiple pregnancy, smokers, any woman in labour or postpartum and inability to consent to study. a. Women less than 24 weeks pregnant will be excluded if body mass index is greater than 32 kg/m2 at the time of the study b. Women equal to or greater than 36 weeks pregnant will be excluded if body mass index equal to or greater than 35 kg/m2 at the time of the study c. Non-pregnant women will be excluded if body mass index is greater than 30 kg/m2 at the time of the study
Outcome results
None listed