Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01545492
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
2012-02-24
Brief Title:
Testing the Developmental Origins Hypothesis
Sponsor:
Childrens Womens Health Centre of British Columbia
Organization:
Childrens Womens Health Centre of British Columbia
Study Overview
Official Title:
CHIPS-ChildTesting the Developmental Origins Hypothesis
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIPS-Child
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 childs 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
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 childs 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 eg 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 childs 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 025 in change in z-score for weight between birth and 12 m 2-sided alpha005 SD 1
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 childs 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 025 in change in z-score for weight between birth and 12 m 2-sided alpha005 SD 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None