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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00187395
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 12, 2009
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Transient Hypertension, Pregnancy Procedure: Randomized to either a 'less tight' group or a 'tight' group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Control of Hypertension in Pregnancy Study: A Pilot Trial
Study Start Date : April 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mean dBP at 28, 32 and 36 weeks gestation

Secondary Outcome Measures :
  1. Clinician compliance with treatment protocols; women's satisfaction with care.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00187395

Canada, Ontario
Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
Toronto, Ontario, Canada, M5G 1N8
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Laura Magee, MD Sunnybrook Health Sciences Centre

Additional Information: Identifier: NCT00187395     History of Changes
Other Study ID Numbers: MCT- 59755
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: September 2005

Keywords provided by Sunnybrook Health Sciences Centre:
blood pressure

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications