CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187395
First received: September 13, 2005
Last updated: March 9, 2009
Last verified: September 2005

September 13, 2005
March 9, 2009
April 2003
Not Provided
Mean dBP at 28, 32 and 36 weeks gestation
Same as current
Complete list of historical versions of study NCT00187395 on ClinicalTrials.gov Archive Site
Clinician compliance with treatment protocols; women's satisfaction with care.
Clinician compliance with treatment protocols; women’s satisfaction with care.
Not Provided
Not Provided
 
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
Control of Hypertension in Pregnancy Study: A Pilot Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Transient Hypertension, Pregnancy
Procedure: Randomized to either a 'less tight' group or a 'tight' group
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
December 2005
Not Provided

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.
Female
18 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00187395
MCT- 59755, ISRCTN57277508
Not Provided
Not Provided
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Laura Magee, MD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP