The Six-Minute Walk Test in Pregnant Women – a Reference Range Study
Research type
Research Study
Full title
The Six-Minute Walk Test in Pregnant Women – a Reference Range Study
IRAS ID
190013
Contact name
Steve Yentis
Contact email
Sponsor organisation
Royal Women's Hospital, Melbourne, Australia
Clinicaltrials.gov Identifier
ACTRN12615000964516, Trial registry number; U1111-1173-7990 , Universal Trial number
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
This international, multicentre, observational study aims to establish the reference range for the six-minute walk test, and the rating of breathlessness with exertion in healthy pregnant women and non-pregnant women of child-bearing age. The six-minute walk test is a simple, non-invasive exercise test that measures the distance an individual is able to cover by walking for 6 minutes. It has been used to assess cardiovascular fitness in non-pregnant adults but has not been utilised in pregnancy. The determination of these outcomes may enable the detection of women with reduced exercise capacity who may be at risk of developing heart disease or raised blood pressure in pregnancy. New onset raised blood pressure in pregnancy is a potentially serious complication that affects around 13 million women throughout the world each year, and it is hypothesised that reduced cardiovascular fitness in pregnant women may be a risk factor for this condition.
The study will be conducted at the Royal Women's Hospital in Melbourne, Chelsea and Westminster Hospital in London, and Mowbray Maternity Hospital in Cape Town over 24 months. Five hundred women will be recruited. Of them, 300 will be healthy nulliparous of ≥ 36 weeks gestation, 100 healthy nulliparous of < 24 weeks gestation, and 100 healthy nulliparous women aged 18-40 years (non-pregnant). (Only women in the first group will be recruited at Chelsea and Westminster Hospital).
This study, as the first in a series of studies, may lead to a reduction in morbidity and mortality from new onset hypertension in pregnant women, thereby benefitting a very large number of women and their families. This study specifically will provide information to women and clinicians about the normal symptoms of pregnancy which in turn will enable a more reliable method of symptom reporting thereby facilitating earlier recognition of cardiovascular complications in pregnant women.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0720
Date of REC Opinion
22 Dec 2015
REC opinion
Further Information Favourable Opinion