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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
INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control \[target diastolic BP (dBP) 100mmHg\] or 'tight' control \[target dBP 85mmHg\] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.

CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination \[anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background\]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.

OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.
Trial website
https://clinicaltrials.gov/study/NCT01545492
Trial related presentations / publications
Wadhwa PD, Buss C, Entringer S, Swanson JM. Developmental origins of health and disease: brief history of the approach and current focus on epigenetic mechanisms. Semin Reprod Med. 2009 Sep;27(5):358-68. doi: 10.1055/s-0029-1237424. Epub 2009 Aug 26.
Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705.
Gilbert EF, Varakis J, Opitz JM, ZuRhein GM, Ware R, Viseskul C, Kaveggia EG, Hartmann HA. Generalized gangliosidosis type II (juvenile GM1 gangliosidosis). A pathological, histochemical and ultrastructural study. Z Kinderheilkd. 1975 Sep 11;120(3):151-80. doi: 10.1007/BF00439006.
Painter RC, Roseboom TJ, Bleker OP. Prenatal exposure to the Dutch famine and disease in later life: an overview. Reprod Toxicol. 2005 Sep-Oct;20(3):345-52. doi: 10.1016/j.reprotox.2005.04.005.
Tobi EW, Lumey LH, Talens RP, Kremer D, Putter H, Stein AD, Slagboom PE, Heijmans BT. DNA methylation differences after exposure to prenatal famine are common and timing- and sex-specific. Hum Mol Genet. 2009 Nov 1;18(21):4046-53. doi: 10.1093/hmg/ddp353. Epub 2009 Aug 4.
Silveira PP, Portella AK, Goldani MZ, Barbieri MA. Developmental origins of health and disease (DOHaD). J Pediatr (Rio J). 2007 Nov-Dec;83(6):494-504. doi: 10.2223/JPED.1728.
Cameron N, Demerath EW. Critical periods in human growth and their relationship to diseases of aging. Am J Phys Anthropol. 2002;Suppl 35:159-84. doi: 10.1002/ajpa.10183.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01545492