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

Control of Hypertension in Pregnancy Study: A Pilot Trial

Sponsors

Lead Sponsor: Sunnybrook Health Sciences Centre

Collaborator: Canadian Institutes of Health Research (CIHR)

Source 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.

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.

Overall Status Completed
Start Date April 2003
Completion Date December 2005
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean dBP at 28, 32 and 36 weeks gestation
Secondary Outcome
Measure Time Frame
Clinician compliance with treatment protocols; women's satisfaction with care.
Enrollment 132
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Randomized to either a 'less tight' group or a 'tight' group

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 48 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Laura Magee, MD Principal Investigator Sunnybrook Health Sciences Centre
Location
Facility: Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
Location Countries

Canada

Verification Date

September 2005

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov