CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
- Conditions
- Transient Hypertension, Pregnancy
- Registration Number
- NCT00187395
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
- dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean dBP at 28, 32 and 36 weeks gestation
- Secondary Outcome Measures
Name Time Method Clinician compliance with treatment protocols; women's satisfaction with care.
Trial Locations
- Locations (1)
Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
🇨🇦Toronto, Ontario, Canada