Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000272493
Ethics application status
Not yet submitted
Date submitted
17/05/2007
Date registered
21/05/2007
Date last updated
21/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Diet and exercise in pregnancy
Scientific title
Weighing pregnant women to achieve ideal weight gains in pregnancy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight gain in pregnancy 1812 0
Condition category
Condition code
Reproductive Health and Childbirth 1902 1902 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will weigh themselves at each antenatal visit from recruitment until 36 weeks gestation and record weight on a patient held record. The aim of weighing is to motivate women to achieve optimal weight gain, and so potentially reduce adverse pregnacy outcomes including fetal macrosomia, hypertension , gestational diabetes.
Intervention code [1] 1763 0
Prevention
Comparator / control treatment
Women in the control group will be weighed at booking and at 36 weeks gestation.
Control group
Active

Outcomes
Primary outcome [1] 2707 0
Optimum maternal weight gain.
Timepoint [1] 2707 0
Weight will be measured at trial entry, and weight gain assessed at 36 weeks gestation.
Secondary outcome [1] 4573 0
Pregnancy outcomes. Pregnancy outcomes including mode of delivery, postpartum haemorrhage, hypertension, gestational diabetes, prematurity, fetal growth
Timepoint [1] 4573 0
Assessed post partum

Eligibility
Key inclusion criteria
Homen with a singleton pregnancy
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
data assessor will be blinded to assignment
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2048 0
University
Name [1] 2048 0
University of Melbourne-Department of Obstetrics and Gynaecology
Country [1] 2048 0
Australia
Primary sponsor type
Individual
Name
Dr Alexis Shub
Address
Country
Secondary sponsor category [1] 1854 0
University
Name [1] 1854 0
University of Melbourne Department of Obstetrics and Gynecology
Address [1] 1854 0
Country [1] 1854 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3802 0
Mercy Hospital for Women
Ethics committee address [1] 3802 0
Ethics committee country [1] 3802 0
Australia
Date submitted for ethics approval [1] 3802 0
Approval date [1] 3802 0
Ethics approval number [1] 3802 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27866 0
Address 27866 0
Country 27866 0
Phone 27866 0
Fax 27866 0
Email 27866 0
Contact person for public queries
Name 10952 0
Dr Alexis Shub
Address 10952 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 10952 0
Australia
Phone 10952 0
+61 3 84584248
Fax 10952 0
Email 10952 0
ashub@internode.on.net
Contact person for scientific queries
Name 1880 0
Dr Alexis Shub
Address 1880 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 1880 0
Australia
Phone 1880 0
+61 3 84584248
Fax 1880 0
Email 1880 0
ashub@internode.on.net

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.