Testing the Developmental Origins Hypothesis
- Conditions
- DiabetesStrokeObesity
- Registration Number
- NCT01545492
- Lead Sponsor
- Children's & Women's Health Centre of British Columbia
- 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.
- Detailed Description
INTRODUCTION: Growing evidence shows that reduced fetal growth rate is associated with adult cardiovascular risk markers (e.g., obesity) and disease, and evidence worldwide indicates that this relationship is independent of birthweight. The leading theory describes 'developmental programming' in utero leading to permanent alteration of the fetal genome. While those changes are adaptive in utero, they may be maladaptive postnatally.
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.
METHODS: 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.
Sample size:. CHIPS will recruit 1028 women. We estimate that 80% of CHIPS centres will participate in CHIPS-Child, approximately 97% of babies will survive, and 90% of children will be followed to 12 m resulting in a sample size of 626. Power will be \>80% to detect a between-group difference of ≥0.25 in 'change in z-score for weight' between birth and 12 m (2-sided alpha=0.05, SD 1).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 626
- All women participating in CHIPS and their children born after recruitment.
- Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method difference in 'change in z score for weight' at 12 m(+/- 2m) birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m Between-group difference in early postnatal weight gain ('change in z score for weight') between birth and 12 m (p\<0.05), 24m, 36m, 48m \& 60m.
- Secondary Outcome Measures
Name Time Method hypothalamic pituitary adrenal axis function average of 12m (+/-2m) of age Hair collected at 12m (+/-2m) of age will be analysed for hypothalamic pituitary adrenal axis function (hair cortisol for overall cortisol production).
differences in DNA methylation average of 12 m (+/- 2m) of age Buccal swab samples collected at 12m (+/-2m) of age will be assessed for between-groups differences in DNA methylation, using targeted (genes associated with growth, obesity, cardiovascular disease, and/or a developmental programming effect) and global (genome-wide microarray) methods.
Trial Locations
- Locations (41)
Hospital Dr Sotero del Rio
🇨🇱Puente Alto, Chile
Norton Hospital Downtown & Suburban
🇺🇸Louisville, Kentucky, United States
VU Medical Center
🇳🇱Amsterdam, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Christchurch Women's Hospital
🇳🇿Christchurch, New Zealand
Hospital Base Osorno
🇨🇱Osorno, Chile
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Tergooiziekenhuizen
🇳🇱Hilversum, Netherlands
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
BC Children & Women's Health Centre
🇨🇦Vancouver, British Columbia, Canada
King Edward Memorial Hospital
🇦🇺Subiaco, Australia
CHUS Fleurimont
🇨🇦Sherbrooke, Ontario, Canada
UMCG
🇳🇱Groningen, Netherlands
Diakonessen Ziekenhuis
🇳🇱Utrecht, Netherlands
UMCU
🇳🇱Utrecht, Netherlands
Maxima Medical Centre
🇳🇱Veldhoven, Netherlands
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Ipswich Hospital
🇦🇺Ipswich, Australia
Hopital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Tartu University Hospital - Women's Clinic
🇪🇪Tartu, Estonia
MUMC Maastricht
🇳🇱Maastricht, Netherlands
Isala Klinieken Zwolle
🇳🇱Zwolle, Netherlands
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
🇬🇧Sunderland, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
York District Hospital
🇬🇧York, United Kingdom
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
OLVG
🇳🇱Amsterdam, Netherlands
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Southport & Ormskirk Hospital
🇬🇧Ormskirk, United Kingdom
Copper University Hospital
🇺🇸Camden, New Jersey, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
🇨🇦Surrey, British Columbia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada