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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of exercise during pregnancy on maternal and neonatal outcomes.
Scientific title
Randomised controlled study of the effects of exercise during pregnancy on maternal insulin sensitivity and neonatal outcomes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 621 0
Condition category
Condition code
Reproductive Health and Childbirth 694 694 0 0
Normal pregnancy

Study type
Description of intervention(s) / exposure
Exercise group: A programme of moderate-intensity aerobic (cycling) exercise performed for 40 minutes, 5 times per week, from 20 weeks gestation to term.
Intervention code [1] 645 0
Comparator / control treatment
Control group: Asked to maintain their current level of habitual physical activity
Control group

Primary outcome [1] 846 0
Maternal insulin sensitivity
Timepoint [1] 846 0
Assessed at 20 weeks and 35 weeks gestation
Secondary outcome [1] 1682 0
Neonatal auxology.
Timepoint [1] 1682 0
Secondary outcome [2] 1683 0
Neonatal and maternal body composition.
Timepoint [2] 1683 0
Assessed two weeks postpartum.

Key inclusion criteria
Healthy non-smoking nulliparous women, with a confirmed singleton pregnancy of less than 20 weeks at enrolment. BMI greater than 18 kg/m2.
Minimum age
20 Years
Maximum age
35 Years
Can healthy volunteers participate?
Key exclusion criteria
A previous pregnancy of greater than 20 weeks; a first-degree relative with diabetes mellitus; the presence of any chronic illness that may affect either the pregnancy or the ability to participate in an exercise programme; the presence of any other medical condition known to be associated with reduced insulin sensitivity and the development of any absolute contraindication for exercise during pregnancy (as defined by ACOG).

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to study groups is performed by an independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is performed by an independent statistician using a computerised random number generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 232 0
New Zealand
State/province [1] 232 0

Funding & Sponsors
Funding source category [1] 769 0
Government body
Name [1] 769 0
National Research Centre for Growth and Development (NZ)
Address [1] 769 0
Country [1] 769 0
New Zealand
Primary sponsor type
University of Auckland
New Zealand
Secondary sponsor category [1] 630 0
Name [1] 630 0
Address [1] 630 0
Country [1] 630 0

Ethics approval
Ethics application status

Brief summary
Physical activity has well-documented health benefits and has been shown to be safe and well-tolerated during pregnancy. Regular exercise during pregnancy may help regulate maternal nutrient supply to the fetus and have important long-term health consequences for offspring. This study will examine the effects of exercise during pregnancy on maternal insulin sensitivity and neonatal outcomes. A cohort of 120 healthy women will be recruited through maternity carers to complete this study. They will be randomised to either a prescribed moderate exercise programme or no-exercise control group for the remainder of pregnancy. Maternal insulin sensitivity will be assessed at baseline and at 35 weeks. Outcomes in offspring will include birth size, body composition, and metabolic markers present in cord blood at birth. Structural and functional changes to the placenta in response to exercise will also be examined. The results of this study will determine the potential benefits of exercise during pregnancy.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35441 0
Address 35441 0
Country 35441 0
Phone 35441 0
Fax 35441 0
Email 35441 0
Contact person for public queries
Name 9834 0
Sarah Hopkins
Address 9834 0
Liggins Institute
University of Auckland
Private Bag 92019
Country 9834 0
New Zealand
Phone 9834 0
+64 3737599
Fax 9834 0
Email 9834 0
Contact person for scientific queries
Name 762 0
Dr Paul Hofman
Address 762 0
Liggins Institute
University of Auckland
Private Bag 92019
Country 762 0
New Zealand
Phone 762 0
+64 3737599
Fax 762 0
Email 762 0

No information has been provided regarding IPD availability
Summary results
No Results