Back to resultsCHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
Primary Purpose
Transient Hypertension, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Randomized to either a 'less tight' group or a 'tight' group
Sponsored by
About this trial
This is an interventional treatment trial for Transient Hypertension, Pregnancy focused on measuring hypertension, blood pressure, pregnancy
Eligibility Criteria
Inclusion Criteria: dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks. Exclusion Criteria: dBP consistently < 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.
Sites / Locations
- Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
Outcomes
Primary Outcome Measures
Mean dBP at 28, 32 and 36 weeks gestation
Secondary Outcome Measures
Clinician compliance with treatment protocols; women's satisfaction with care.
Full Information
NCT ID
NCT00187395
First Posted
September 13, 2005
Last Updated
March 9, 2009
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00187395
Brief Title
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
Official Title
Control of Hypertension in Pregnancy Study: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
Brief Summary
Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.
Detailed Description
To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Hypertension, Pregnancy
Keywords
hypertension, blood pressure, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Randomized to either a 'less tight' group or a 'tight' group
Primary Outcome Measure Information:
Title
Mean dBP at 28, 32 and 36 weeks gestation
Secondary Outcome Measure Information:
Title
Clinician compliance with treatment protocols; women's satisfaction with care.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.
Exclusion Criteria:
dBP consistently < 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Magee, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.sunnybrook.ca/research/?page=sri_proj_cmicr_trial_chips_home
Description
CHIPS Pilot Trial website
Learn more about this trial
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
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