CHIPS (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.
Transient Hypertension, Pregnancy
Procedure: Randomized to either a 'less tight' group or a 'tight' group
|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|
- Mean dBP at 28, 32 and 36 weeks gestation
- Clinician compliance with treatment protocols; women's satisfaction with care.
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||December 2005|
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.
|Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre|
|Toronto, Ontario, Canada, M5G 1N8|
|Principal Investigator:||Laura Magee, MD||Sunnybrook Health Sciences Centre|