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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01545492




Registration number
NCT01545492
Ethics application status
Date submitted
24/02/2012
Date registered
6/03/2012
Date last updated
6/03/2012

Titles & IDs
Public title
Testing the Developmental Origins Hypothesis
Scientific title
CHIPS-Child:Testing the Developmental Origins Hypothesis
Secondary ID [1] 0 0
H08-00882CHIPS-Child
Universal Trial Number (UTN)
Trial acronym
CHIPS-Child
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Stroke 0 0
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tight - Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control \[target diastolic BP 85mmHg\]

Less Tight - Children born to women in the CHIPS RCT randomized to "Less Tight" \[target diastolic BP 100mmHg\].
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
difference in 'change in z score for weight' at 12 m(+/- 2m)
Timepoint [1] 0 0
birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m
Secondary outcome [1] 0 0
hypothalamic pituitary adrenal axis function
Timepoint [1] 0 0
average of 12m (+/-2m) of age
Secondary outcome [2] 0 0
differences in DNA methylation
Timepoint [2] 0 0
average of 12 m (+/- 2m) of age

Eligibility
Key inclusion criteria
* All women participating in CHIPS and their children born after recruitment.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
626
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [2] 0 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
- Ipswich
Recruitment postcode(s) [2] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
Chile
State/province [11] 0 0
Osorno
Country [12] 0 0
Chile
State/province [12] 0 0
Puente Alto
Country [13] 0 0
Estonia
State/province [13] 0 0
Tartu
Country [14] 0 0
Netherlands
State/province [14] 0 0
Amsterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
Groningen
Country [16] 0 0
Netherlands
State/province [16] 0 0
Hilversum
Country [17] 0 0
Netherlands
State/province [17] 0 0
Maastricht
Country [18] 0 0
Netherlands
State/province [18] 0 0
Nieuwegein
Country [19] 0 0
Netherlands
State/province [19] 0 0
Utrecht
Country [20] 0 0
Netherlands
State/province [20] 0 0
Veldhoven
Country [21] 0 0
Netherlands
State/province [21] 0 0
Zwolle
Country [22] 0 0
New Zealand
State/province [22] 0 0
Christchurch
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Birmingham
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Bradford
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Lancaster
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Newcastle Upon Tyne
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Nottingham
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Ormskirk
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Plymouth
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sunderland
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Swansea
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Wolverhampton
Country [33] 0 0
United Kingdom
State/province [33] 0 0
York

Funding & Sponsors
Primary sponsor type
Other
Name
Children's & Women's Health Centre of British Columbia
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Laura A Magee, MD
Address 0 0
BC Children & Women's Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kristal T Louie, MS
Address 0 0
Country 0 0
Phone 0 0
604.875.2424
Fax 0 0
Email 0 0
CHIPS-Child@cw.bc.ca
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01545492