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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
History of Changes
  Purpose

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 Intervention
Transient Hypertension, Pregnancy
 Procedure: Randomized to either a 'less tight' group or a 'tight' group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Control of Hypertension in Pregnancy Study: A Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

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.

Estimated Enrollment: 132
Study Start Date: April 2003
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187395

Locations
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)
Investigators
Principal Investigator: Laura Magee, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
CHIPS Pilot Trial website  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00187395     History of Changes
Other Study ID Numbers: MCT- 59755, ISRCTN57277508
Study First Received: September 13, 2005
Last Updated: March 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
hypertension
blood pressure
pregnancy

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

ClinicalTrials.gov processed this record on May 23, 2013