Recruiting

Observational Study

Sponsor:

Children's & Women's Health Centre of British Columbia

Code:

NCT01545492

Conditions

Diabetes

Stroke

Obesity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Diabetes

Stroke

Obesity

Study ID

NCT01545492

Start date

Jan, 2012

Status verified date

Mar, 2012

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All women participating in CHIPS and their children born after recruitment.

Exclusion Criteria:

  • Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.

Study Design

Enrollment

626 participants

Anticipated

Interventions and Outcome Measures

Arms

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" \[target diastolic BP 100mmHg\].

Primary outcome measure

  • difference in 'change in z score for weight' at 12 m(+/- 2m) [ Time Frame: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m ]

Central Contacts and Locations

Central contacts

Locations

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Norton Hospital Downtown & Suburban

Recruiting

Louisville, Kentucky, United States, 40202

Copper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada

Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre

Recruiting

Surrey, British Columbia, Canada

BC Children & Women's Health Centre

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Principal Investigator:

Laura A Magee, MD FRCPC MSc

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada

London Health Sciences Centre

Recruiting

London, Ontario, Canada

CHUS Fleurimont

Recruiting

Sherbrooke, Ontario, Canada

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Hopital Sainte-Justine

Recruiting

Montreal, Quebec, Canada

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada

More Information

Sponsor

Children's & Women's Health Centre of British Columbia

Last update posted

Mar 6, 2012

Last verified

Mar, 2012

Keywords

  • CHIPS
  • famine
  • reprogramming
  • developmental
  • blood
  • pressure
  • randomised
  • randomized
  • hypertension
  • anthropometry
  • measurement
  • genetics
  • epigenetics
  • methylation
  • cortisol
  • stress
  • DNA
  • growth
  • weight
  • length
  • height

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's & Women's Health Centre of British Columbia on 2012-03-06.